Cavities of Teeth, Cavity
Conditions
Keywords
Dental Composite
Brief summary
The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
Detailed description
A recent review on clinical studies published on the performance of posterior composite restorations that were recalled at least up to 24-months reported that the overall failure rates for studies conducted between 2006-2016 was 13.13% and the two main reasons for failure in these two decades remained the same, i.e. secondary caries (25.68% - 29.47%) and composite fracture (28.84% - 39.07%). In in vitro studies, secondary caries has been attributed to interfacial gap or marginal defect both of which are consequences of polymerization contraction stresses. However, to date no clinical study has been able to directly establish a link between these stresses (and its consequences) to secondary caries. World Dental Federation (FDI) and United States Public Health Service (USPHS) clinical assessment criteria are the two main systems used to evaluate dental restorations in clinical trials. Both systems are designed to evaluate different properties of a restoration and properties pertaining to marginal integrity has been reported to be the most frequent properties investigated of a resin composite restoration. The grading descriptions for these properties are subjective and the discrimination between grading and between properties (especially between marginal stains and secondary caries) are problematic. Reasons to the lack of such a link is the discriminative deficiency of the clinical visual evaluation systems, the FDI and USPHS assessment criteria, and the ethical dilemma of restoration removal to assess for presence or absence of secondary caries. It has been long acknowledged that an objective clinical measuring tool and new clinical study designs for secondary caries is needed to further the understanding of secondary caries initiation and progression and how these relates to the marginal integrity of dental restorations. This brings forth the need of a sensitive yet clinically applicable assessment method for interfacial debonding and demineralization. Optical coherence tomography (OCT) is an optical, nondestructive and clinically- applicable technique that uses near infra red-light waves to provide cross-sectional images of structures. It is regarded as a standard-of-care equipment in ophthalmology and its clinical application has recently expanded to cardiology and dermatology. In dentistry, it has been used intra-orally in clinical trials to detect and quantify enamel demineralization and to detect mucosal and submucosal lesions. Optical coherence tomography and has been used to assess the performance of dental adhesives in a 12-month in vivo trial on non-carious cervical lesion. The authors reported that OCT outcome measures detected significant differences between groups while visual assessments did not. Hence supplementing the two visual assessment techniques with OCT outcome measures is expected to increase the sensitivity of short term interfacial debonding and demineralization changes. The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
Interventions
DEVICEComposite with 90 degree cavosurface angle
Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
DEVICEComposite with wide bevel
Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Good general health * Fair oral hygiene * At least 20 teeth in occlusion * Available for the duration of the study Tooth-level inclusion Criteria: * Participants with occlusal caries lesion/s in permanent posterior dentition except wisdom teeth * Caries lesion can be primary or secondary caries. * Caries lesion is in the International Caries Detection and Assessment System (ICDAS) 4 or 5 category. * The extent of the caries lesion bucco-lingually is likely not to exceed two-thirds of the occlusal table. * The selected tooth must be able to be isolated with either rubber dam or other isolation technique during clinical procedure. * The selected tooth must have an opposing antagonist. * The selected tooth should be periodontally healthy.
Exclusion criteria
\- Signs of bruxism Tooth-level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | 18 months post-operative | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 18 months post-operative. |
| Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative | 18 months post-operative | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality. |
| Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | Baseline | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at baseline. |
| Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | 6 months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 6 months post-operative. |
| Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Baseline | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at baseline. |
| Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | 6 months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 6 months post-operative. |
| Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | 18 months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 18 months post-operative. |
| Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | Baseline | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at baseline. |
| Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | 6 months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 6 months post-operative. |
| Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | 18 months Follow-up | The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 18 months post-operative. |
| Marginal Defect: World Dental Federation (FDI) Criteria - Baseline | Baseline | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality. |
| Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up | 6 months Follow-up | The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tooth-resin Interface Gap at the Occlusal Cavosurface Angle. | Baseline | Presence of tooth-resin interface gap of more than 0.1 mm at the cavosurface angle (margins) of the restoration, which indicates presence of moderate marginal defect, will be computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. |
| Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls | Baseline | Presence of elevated backscattered intensity along the superficial 2mm depth walls of the restoration, which indicates presence of debonding, will be computed as percentage volume of the restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. |
| Backscattered Intensity at the Occlusal Cavosurface Angle. | Baseline | Presence of elevated intensity at the cavosurface angle (margins) of the restoration, which indicates presence of minor marginal defect, is computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on referral from the dental clinics of the School of Dentistry University of Minnesota and enquiries from the public upon seeing flyers pasted at the Malcolm Moos Tower. The first and last participant were enrolled on 09/23/2021 and 7/15/22 respectively.
Pre-assignment details
Upon referral from the dental clinic or enquiries, potential participants were invited to attend a telemeeting where the participants were presented with the information of the trial using a MS Powerpoint slide deck. 46 participants were invited to the telemeeting and also attended an in-person screening session to determine whether they meet the inclusion criteria of the study. 36 met the inclusion criteria and were successfully enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins
Composite with 90 degree cavosurface angle: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. | 18 |
| Group 2 Lesion-specific cavity design with wide bevel throughout the cavity margins
Composite with wide bevel: Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. | 18 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 5 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 18 Participants | 34 Participants |
| Age, Continuous | 32.56 years STANDARD_DEVIATION 14.51 | 30.17 years STANDARD_DEVIATION 7.85 | 31.36 years STANDARD_DEVIATION 11.18 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 1 / 18 | 2 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 18 months post-operative.
Time frame: 18 months post-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | Score A | 14 Participants |
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | Score B | 0 Participants |
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | Score C | 0 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | Score A | 13 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | Score B | 0 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative | Score C | 0 Participants |
Primary
Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 6 months post-operative.
Time frame: 6 months Follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score A | 16 Participants |
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score B | 0 Participants |
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score C | 0 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score A | 17 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score B | 0 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score C | 0 Participants |
Primary
Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at baseline.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | Score A | 18 Participants |
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | Score B | 0 Participants |
| Group 1 | Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | Score C | 0 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | Score A | 18 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | Score B | 0 Participants |
| Group 2 | Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline | Score C | 0 Participants |
Primary
Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.
Time frame: 18 months post-operative
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative | 100% Score 1 | 8 Participants |
| Group 1 | Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative | 80 - 99 % Score 1 | 6 Participants |
| Group 2 | Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative | 100% Score 1 | 7 Participants |
| Group 2 | Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative | 80 - 99 % Score 1 | 6 Participants |
Primary
Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.
Time frame: 6 months Follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up | 100% Score 1 | 12 Participants |
| Group 1 | Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up | <100% Score 1 | 4 Participants |
| Group 2 | Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up | 100% Score 1 | 12 Participants |
| Group 2 | Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up | <100% Score 1 | 5 Participants |
Primary
Marginal Defect: World Dental Federation (FDI) Criteria - Baseline
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and \<100%) of the total length of the margin that is of Score 1 quality.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Defect: World Dental Federation (FDI) Criteria - Baseline | 100% of Score 1 | 7 Participants |
| Group 1 | Marginal Defect: World Dental Federation (FDI) Criteria - Baseline | <100% Score 1 | 11 Participants |
| Group 2 | Marginal Defect: World Dental Federation (FDI) Criteria - Baseline | 100% of Score 1 | 8 Participants |
| Group 2 | Marginal Defect: World Dental Federation (FDI) Criteria - Baseline | <100% Score 1 | 10 Participants |
Primary
Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 18 months post-operative.
Time frame: 18 months Follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | Score A | 14 Participants |
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | Score B | 0 Participants |
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | Score C | 0 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | Score A | 13 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | Score B | 0 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up | Score C | 0 Participants |
Primary
Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 6 months post-operative.
Time frame: 6 months Follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score A | 16 Participants |
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score B | 0 Participants |
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score C | 0 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score A | 17 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score B | 0 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up | Score C | 0 Participants |
Primary
Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at baseline.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | Score A | 18 Participants |
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | Score B | 0 Participants |
| Group 1 | Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | Score C | 0 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | Score A | 18 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | Score B | 0 Participants |
| Group 2 | Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline | Score C | 0 Participants |
Primary
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 18 months post-operative.
Time frame: 18 months Follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 2 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 4 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 3 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 5 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 1 | 14 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 5 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 1 | 13 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 2 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 3 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up | Score 4 | 0 Participants |
Primary
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 6 months post-operative.
Time frame: 6 months Follow-up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 2 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 4 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 3 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 5 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 1 | 16 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 5 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 1 | 17 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 2 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 3 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up | Score 4 | 0 Participants |
Primary
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at baseline.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 5 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 1 | 18 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 2 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 3 | 0 Participants |
| Group 1 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 4 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 4 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 3 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 1 | 18 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 5 | 0 Participants |
| Group 2 | Marginal Staining: World Dental Federation (FDI) Criteria - Baseline | Score 2 | 0 Participants |
Secondary
Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls
Presence of elevated backscattered intensity along the superficial 2mm depth walls of the restoration, which indicates presence of debonding, will be computed as percentage volume of the restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls | 16.20 Percentage | Standard Error 4.85 |
| Group 2 | Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls | 7.43 Percentage | Standard Error 5.3 |
Secondary
Backscattered Intensity at the Occlusal Cavosurface Angle.
Presence of elevated intensity at the cavosurface angle (margins) of the restoration, which indicates presence of minor marginal defect, is computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Backscattered Intensity at the Occlusal Cavosurface Angle. | 6.75 Percentage area | Standard Error 6.36 |
| Group 2 | Backscattered Intensity at the Occlusal Cavosurface Angle. | 1.56 Percentage area | Standard Error 4.33 |
Secondary
Tooth-resin Interface Gap at the Occlusal Cavosurface Angle.
Presence of tooth-resin interface gap of more than 0.1 mm at the cavosurface angle (margins) of the restoration, which indicates presence of moderate marginal defect, will be computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Tooth-resin Interface Gap at the Occlusal Cavosurface Angle. | 14.44 Percentage | Standard Error 4.36 |
| Group 2 | Tooth-resin Interface Gap at the Occlusal Cavosurface Angle. | 18.75 Percentage | Standard Error 17.63 |