Cavities of Teeth, Dental Decay
Conditions
Keywords
dental materials, dental adhesives, dental fillings, dental cavities, Scotchbond Universal Plus, Scotchbond Universal, Filtek Universal Restorative
Brief summary
This research study is looking at a new bond-promoting substance (a dental adhesive called 3M™ Scotchbond™ Universal Plus Adhesive) used between the tooth and dental restoration (filling). This is a randomized, split-mouth study designed to evaluate whether Scotchbond™ Universal Plus Adhesive (SBU+) is as effective at bonding dental fillings as Scotchbond™ Universal Adhesive (SBU) for preparation of posterior Class I and Class II restorations in adult patients. Participants must have at least two (2) back teeth that need a filling either on the chewing surface alone (Class I) and/or on the chewing surface and between your teeth (Class II). One tooth will be restored using SBU+ and the other tooth will be restored using SBU adhesive, both filled using Filtek™ Universal Restorative as the filling material.
Detailed description
This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study. The study is designed to compare the clinical efficacy of Scotchbond™ Universal Plus Adhesive with Scotchbond™ Universal Adhesive when used in self-etch mode for preparation of posterior Class I and Class II restorations using Filtek™ Universal Restorative material in adult patients. Selected endpoints are based partly on the FDI World Dental Federation criteria. Subjects who meet all inclusion and none of the exclusion criteria and who have provided informed consent will be eligible for enrollment and must be treated within 21 days of screening. Either two pre-molars or two molars from each Subject will be randomized in a 1:1 ratio such that one of the teeth will be randomized to undergo restoration using SBU+ Adhesive (Treatment), and the other tooth will undergo restoration using SBU Adhesive (Control). Both study teeth will be restored using Filtek™ Universal Restorative material as the filling material. Individual subject participation is expected to last 2 years (± 45 days) with scheduled study visits at screening, day of restoration/baseline, and follow-up visits at 6 months (± 14 days), 1 year (± 30 days), and 2 years (± 45 days) after restoration. The entire duration of the study is expected to last approximately 3 years, with individual Subject participation expected to last up to 2 years (± 45 days). To help minimize or avoid bias in the study, randomization of study teeth will occur after teeth preparation but before the initial application of any adhesive. All assessments will be performed by two dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms. All examiners will be trained and calibrated for the scoring criteria before any Subject assessment occurs, and examiners will be retrained and recalibrated if any new evaluator is added to the list of assessors. After the second examiner has completed their assessments, then the examiners will compare their evaluations and a consensus will be reached for each of the scoring criteria at each visit. A consensus will be reached before the Subject leaves the visit, and the consensus assessments will be entered into the Case Report Form (CRF).
Interventions
DEVICEScotchbond™ Universal Plus Adhesive
Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative
DEVICEScotchbond™ Universal Adhesive
Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative
Sponsors
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
All assessments will be performed by two dental examiners that are independent of the dentist that placed the restorations and are blinded to the treatment arms.
Intervention model description
This is a prospective, randomized, controlled, open-label, assessor-blinded, split-mouth, single-center post-market clinical follow-up study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. The Subject is between the ages of 18 and 70 years old at time of consent. 2. The Subject requires at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (\< 1 mm in the buccolingual direction). 3. Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps 4. Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established. 5. The Subject is able and willing to sign Informed Consent Form in English without assistance. 6. The Subject is able and willing to be available for all scheduled study visits. 7. The Subject is in good general health (ie, meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria). 8. The selected teeth need to have occlusal contact with an antagonistic natural tooth. 9. The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.
Exclusion criteria
1. The Subject has a history of adverse reaction to any materials used in this study. 2. The Subject is pregnant or breast feeding at the time of screening. 3. The Subject has fewer than 20 teeth. 4. The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study. 5. The Subject has advanced periodontal disease (ie, Grace & Smales Mobility Index grade ≥ 2) that involve the study teeth. 6. The Subject had orthodontic appliance treatment within the previous 3 months. 7. The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism. 8. The Subject has severe xerostomia. 9. The study tooth has a history of or existing, prolonged tooth hypersensitivity. 10. The study tooth is an abutment for fixed or removable prostheses. 11. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth. 12. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system. 13. The Subject is unable to understand study procedures or provide consent in English. 14. The Subject is an employee or student of the study investigator(s). Intraoperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of Restorative Material | 24 months post-restoration | The percentage of restorations with partial or complete loss of the restoration materials |
| Fracture of Restorative Material | 24 months post-restoration | Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria. |
| Marginal Adaptation | 24 months post-restoration | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention of Restorative Material | 6 months post-restoration | The percentage of restorations with partial or complete loss of the restoration materials |
| Fracture of Restorative Material | 6 months post-restoration | Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria. |
| Marginal Adaptation | baseline day of restoration | Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria. |
Countries
United States
Participant flow
Recruitment details
The patient population was selected from current patients under clinical treatment at the University of Minnesota Dental School. Patients were between the ages of 18 and 70 years old at time of consent, of either sex, and of any ethnic background. Eligible patients needed to have at least two direct composite restorations for posterior (premolars or molars) Class I or Class II carious lesions in vital teeth that were asymptomatic and with minimal mobility.
Pre-assignment details
Subjects were required to meet all inclusion and none of the exclusion criteria to be eligible for study participation. Any subject with pulp exposure of either study tooth during the restoration procedure was excluded from the study. Two Class I or Class II restorations were placed per patient. Selected study teeth were randomized in a 1:1 ratio with one tooth restored using SBU+ Adhesive (Treatment), and the other tooth restored using SBU Adhesive (Control).
Participants by arm
| Arm | Count |
|---|---|
| Scotchbond Universal Plus Treatment Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).
Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative | 51 |
| Scotchbond Universal Plus Treatment Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using Scotchbond Universal Plus (SBU+) Adhesive (Treatment).
Scotchbond™ Universal Plus Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU+ treatment group will undergo restoration with Scotchbond™ Universal Plus Adhesive using self-etch mode and Filtek Universal Restorative | 51 |
| Scotchbond Universal Comparator Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).
Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative | 51 |
| Scotchbond Universal Comparator Study tooth with posterior Class I or Class II carious lesion randomized to undergo restoration using the predicate device, Scotchbond Universal (SBU) Adhesive (Control).
Scotchbond™ Universal Adhesive: Eligible tooth with Class I or Class II carious lesion randomized to the SBU control group will undergo restoration with Scotchbond™ Universal Adhesive using self-etch mode and Filtek Universal Restorative | 51 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 13 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Scotchbond Universal Comparator | Total | Scotchbond Universal Plus Treatment |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 12.4 | 33 years STANDARD_DEVIATION 12.4 | 33 years STANDARD_DEVIATION 12.4 |
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 19 years to 64 years | 50 Participants | 50 Participants | 50 Participants |
| Age, Customized >= 65 years | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity: Hispanic or Latino | 5 Participants | 5 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino | 44 Participants | 44 Participants | 44 Participants |
| Race/Ethnicity, Customized Ethnicity: Unknown or Not Reported | 2 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race: American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race: Asian | 9 Participants | 9 Participants | 9 Participants |
| Race/Ethnicity, Customized Race: Black or African American | 12 Participants | 12 Participants | 12 Participants |
| Race/Ethnicity, Customized Race: Multiple Race | 4 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Race: Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race: Other | 3 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race: White | 23 Participants | 23 Participants | 23 Participants |
| Region of Enrollment United States | 51 participants | 51 participants | 51 participants |
| Sex/Gender, Customized Female | 28 Participants | 28 Participants | 28 Participants |
| Sex/Gender, Customized Male | 23 Participants | 23 Participants | 23 Participants |
| Tooth Characteristic: Restoration Class Class II Restorations | 22 Restorations | 47 Restorations | 25 Restorations |
| Tooth Characteristic: Restoration Class Class I Restorations | 29 Restorations | 55 Restorations | 26 Restorations |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 8 / 51 | 8 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Fracture of Restorative Material
Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI (Fédération Dentaire Internationale) World Dental Federation criteria.
Time frame: 24 months post-restoration
Population: 38 subjects completed the study; 1 subject had 1 tooth withdrawn prior to 24 months~Scoring categories for the fracture of restorative material are defined as follows:~1. Excellent/very good: No fractures/cracks~2. Good: Small hairline cracks~3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact~4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 1. Excellent/Very Good | 97 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 3. Sufficient/Satisfactory | 3 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 2. Good | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 2. Good | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 1. Excellent/Very Good | 100 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 3. Sufficient/Satisfactory | 0 percentage of restorations |
Primary
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Time frame: 24 months post-restoration
Population: Scoring categories for marginal adaptation are defined as follows:~1. Excellent/very good: No clinically detectable gap.~2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.~3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area.~4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base.~5. Poor: Generalized major gap or irregularities; or the restoration is loose but in situ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 2. Good | 92 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 3. Sufficient/Satisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 1. Excellent/Very Good | 8 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 1. Excellent/Very Good | 4 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 2. Good | 94 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 3. Sufficient/Satisfactory | 2 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
Primary
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration materials
Time frame: 24 months post-restoration
Population: 38 subjects completed the study; 1 subject in the treatment group had 1 tooth withdrawn prior to 24 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Retention of Restorative Material | No loss of restorative material | 97 percentage of restorations |
| Scotchbond Universal Plus Treatment | Retention of Restorative Material | Partial or complete loss of restorative material | 3 percentage of restorations |
| Scotchbond Universal Comparator | Retention of Restorative Material | No loss of restorative material | 100 percentage of restorations |
| Scotchbond Universal Comparator | Retention of Restorative Material | Partial or complete loss of restorative material | 0 percentage of restorations |
Secondary
Fracture of Restorative Material
Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.
Time frame: 6 months post-restoration
Population: Ten (10) of 51 subjects missed the 6-month follow-up visit.~Scoring categories for the fracture of restorative material are defined as follows:~1. Excellent/very good: No fractures/cracks~2. Good: Small hairline cracks~3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact~4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 1. Excellent/Very Good | 93 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 2. Good | 2 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 3. Sufficient/Satisfactory | 5 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 1. Excellent/Very Good | 98 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 3. Sufficient/Satisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 2. Good | 2 percentage of restorations |
Secondary
Fracture of Restorative Material
Fractures on study teeth graded on a 0-4 grading scale with a score of 1 being Excellent/very good and a score of 4 being Unsatisfactory. Grading scale is based on modified FDI World Dental Federation criteria.
Time frame: 12 months post-restoration
Population: Six of 51 subjects missed 1-year visit; 1 completed this visit but outside allowed window and was excluded from analysis.~Scoring categories for this endpoint are:~1. Excellent/very good: No fractures/cracks~2. Good: Small hairline cracks~3. Sufficient/Satisfactory: Two or more or larger hairline cracks and/or material chip fracture not affecting the marginal integrity or approximal contact~4. Unsatisfactory: Material chip fractures which damage marginal quality or approximal contacts
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 3. Sufficient/Satisfactory | 2.3 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 1. Excellent/Very Good | 95.4 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Fracture of Restorative Material | 2. Good | 2.3 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 1. Excellent/Very Good | 100 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 3. Sufficient/Satisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Fracture of Restorative Material | 2. Good | 0 percentage of restorations |
Secondary
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Time frame: 12 months post-restoration
Population: 44/51 subjects returned for this visit.~Scoring categories for this result are:~1. Excellent/very good: No clinically detectable gap~2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing~3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area~4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base~5. Poor: Generalized major gap or irregularities; or restoration is loose but in situ
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 2. Good | 80 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 3. Sufficient/Satisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 1. Excellent/Very Good | 20 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 1. Excellent/Very Good | 29.55 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 2. Good | 65.9 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 3. Sufficient/Satisfactory | 4.55 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
Secondary
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Time frame: baseline day of restoration
Population: Scoring categories for marginal adaptation are defined as follows:~1. Excellent/very good: No clinically detectable gap.~2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing.~3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area.~4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base.~5. Poor: Generalized major gap or irregularities; or the restoration is loose but in situ.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 2. Good | 67 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 3. Sufficient/Satisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 1. Excellent/Very Good | 33 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 1. Excellent/Very Good | 37 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 2. Good | 63 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 3. Sufficient/Satisfactory | 0 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
Secondary
Marginal Adaptation
Marginal adaptation of restorations graded on a scale of 1-5 with a score of 1 being Excellent/very good and a score of 5 being Poor. Grading scale is based on modified FDI World Dental Federation criteria.
Time frame: 6 months post-restoration
Population: 10 of 51 subjects missed 6-month visit.~Scoring categories for this result are:~1. Excellent/very good: No clinically detectable gap~2. Good: Marginal integrity deviates from the ideal but could be upgraded to ideal by polishing~3. Sufficient/satisfactory: Leakage/discoloration is present but limited to the marginal area~4. Unsatisfactory: Localized major gap that may result in exposure of dentine or base~5. Poor: Generalized major gap or irregularities; or restoration is loose but in situ
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 2. Good | 76 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 3. Sufficient/Satisfactory | 2 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Marginal Adaptation | 1. Excellent/Very Good | 22 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 5. Poor | 0 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 1. Excellent/Very Good | 17.1 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 2. Good | 80.5 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 3. Sufficient/Satisfactory | 2.4 percentage of restorations |
| Scotchbond Universal Comparator | Marginal Adaptation | 4. Unsatisfactory | 0 percentage of restorations |
Secondary
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration materials
Time frame: 6 months post-restoration
Population: Ten (10) of 51 subjects missed the 6-month follow-up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Retention of Restorative Material | No loss of restorative material | 100 percentage of restorations |
| Scotchbond Universal Plus Treatment | Retention of Restorative Material | Partial or complete loss of restorative material | 0 percentage of restorations |
| Scotchbond Universal Comparator | Retention of Restorative Material | No loss of restorative material | 100 percentage of restorations |
| Scotchbond Universal Comparator | Retention of Restorative Material | Partial or complete loss of restorative material | 0 percentage of restorations |
Secondary
Retention of Restorative Material
The percentage of restorations with partial or complete loss of the restoration materials
Time frame: 12 months post-restoration
Population: Six (6) of 51 subjects missed the 1-year follow-up visit. One (1) subject completed the 1-year follow-up visit, but outside the allowed time window and was excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Scotchbond Universal Plus Treatment | Retention of Restorative Material | Partial or complete loss of restorative material | 0 percentage of restorations |
| Scotchbond Universal Plus Treatment | Retention of Restorative Material | No loss of restorative material | 100 percentage of restorations |
| Scotchbond Universal Comparator | Retention of Restorative Material | No loss of restorative material | 100 percentage of restorations |
| Scotchbond Universal Comparator | Retention of Restorative Material | Partial or complete loss of restorative material | 0 percentage of restorations |