Caries, Salivary Function, Tooth Sensitivity
Conditions
Keywords
Icon
Brief summary
This is a three year single site clinical evaluation of a FDA approved (510(k):K100062) lesion penetrating resin used to infiltrate and hamper progression of proximal carious lesions. The purpose of this study is to compare lesion progression infiltrated with (Icon, Hamburg, Germany) to a similar sized lesion in the same patient treated with a placebo. The study is designed as a randomized, controlled, prospective clinical trial with a three year follow-up evaluation period. The clinical site will enroll 150 subjects (in the age range of 19 years or older) with 2 study lesions. The patients will be evaluated at six time points over a period of 3 years. Lesion status and caries risk will be monitored at 6-month intervals, while radiographic evaluation will be conducted at 12-month intervals at 1-, 2- and 3-year recall visits.
Detailed description
Introduction Dental caries is the most widespread of all diseases. It causes destruction of tooth structure by dissolving the enamel on the outside of the tooth first and then progressing into the inside of the tooth. While it is possible to use traditional dental fillings to replace diseased tooth structure, it is far better to slow down or reverse the disease process so that no fillings are needed. One of the most difficult places to use preventive or non-surgical treatment is the contact area between teeth. Recently there is evolving interest in using composites to infiltrate enamel and dentin areas that have just begun to be destroyed by caries. The infiltration technique arrests the lesion progression by sealing the porous surface and restores the damage avoiding ongoing acidic damage of tooth structure. Objective Assess the clinical efficacy s of using Icon to infiltrate initial lesions below the tooth surfaces that exist on the contact surfaces between posterior teeth as a means of stabilizing diseased tooth structure and arresting further lesion development. Materials and Methods One hundred fifty volunteers (19+ years) with two early lesions in posterior teeth will be enrolled into a clinical trial to evaluate the clinical efficacy of infiltrating the lesions as compared to current watch-and-wait approaches that are combined with good oral hygiene and fluoride application. Each subject will have a treated lesion and a control lesion. Only small early lesions without clinical signs of surface cavitation will be selected. The control lesions will be stabilized through a normal preventive regimen, while the treatment lesions will be infiltrated with a resin. Lesion status will be monitored every six months by clinical examination and as well using annual radiographs. Clinical Significance Infiltrating a caries lesion is a potential effective strategy to strengthen damaged tooth structure and to reduce caries progression without any surgical intervention.
Interventions
DEVICEResin infiltration
The study is a split-mouth design. One tooth with a proximal caries lesion will randomly receive the infiltrating resin (Icon) while the other will receive a placebo, according to the manufactures´ instruction for Icon. In short, teeth will be isolated with a rubber dam and the tooth surface cleaned with non-fluoride prophylactic paste and pumice. The Icon material will be applied following the manufacturer's instructions and light cured, followed by polished using interproximal finishing/polishing strips (Sof Lex, 3M ESPE, St Paul, MN). Subjects will be given a letter to take to their local dentist asking them not to treat the selected lesions without informing the investigator first.
OTHERMock treatment
For the mock treatment the procedure will be identical to the Resin Infiltration intervention, with the exception that a placebo will be used. Essentially, syringes identical to the Icon materials will be supplied by DMG for the placebo procedure. The syringes will be filled with solutions having the same consistency and color as the Icon material.
Sponsors
DMG Dental Material Gesellschaft mbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Split-mouth design
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be age 19 years and older * Have at least two vital carious teeth with caries ranging from enamel to just into dentin. * If the lesion is not on a 3rd molar * If the lesion is not developmental. * If the lesion is not cavitated * Be a regular dental attendee able to return for assessments * Be in good medical health and able to tolerate the dental procedure * Have no chronic periodontitis which could compromise tooth retention. * Have normal salivary function. * Have normal bone levels * No lingering cold sensitivity * No periapical sensitivity * No sensitivity to percussion
Exclusion criteria
* Do not meet the inclusion criteria * Are not able to tolerate the time required for the study * There is a history of an adverse reaction to any materials used in the study * They are irregular dental attendees * They maintain an unacceptable standard of oral hygiene. * They have chronic periodontitis * There is severe salivary gland dysfunction or reduced salivary flow is observed * They are unable to return for recall appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Invasive Interventions (Fillings) | 3 years | Cumulative number of study lesions that have progressed to a state were an invasive intervention (filling) has been required to restore the teeth as determined via an dental examination (baseline versus 3 year follow up). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling) | 6 months and 12 months | Change in categorical lesion depth (progression to next depth category lesion; E1-\>E2-\>D1-\>D2-\>filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin). Reference: Anusavice K. Present and future approaches for the control of caries. J Dent Educ. 2005;69(5):538-854. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | 6 months and 12 months | Teeth included in the study were clincially assed for sensitivity to percussion, papillary bleeding, cold response. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from patients seeking treatment at the University of Alabama at Birmingham, School of Dentistry, USA, and through advertisements. The first participant was enrolled in August 2015 and the last was enrolled in August 2017.
Pre-assignment details
Within-person study (split-mouth design): Per participant at least one lesion pair (two lesions on seperate teeth) were included. These two lesions were randomly allocated to either treatment (resin infiltration) or control (mock treatment) group resulting in paired lesions within the participants. For some participants more than one lesion pair was included.
Participants by arm
| Arm | Count |
|---|---|
| Resin Infiltration / Mock Treatment (Split-mouth; Participants With Paired Lesions) Within-person study (split-mouth design): For each participant at least one pair of lesions has been included, whereas one lesion per pair was randomized to the treatment group (resin infiltration) and the other to the control group (mock treatment).
Resin infiltration or Mock treatment was performed at baseline (study start) according to manufacturers' instructions for the respective study lesion; in addition to general caries preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen). | 56 |
| Resin Infiltration / Mock Treatment (Split-mouth; Participants With Paired Lesions) Within-person study (split-mouth design): For each participant at least one pair of lesions has been included, whereas one lesion per pair was randomized to the treatment group (resin infiltration) and the other to the control group (mock treatment).
Resin infiltration or Mock treatment was performed at baseline (study start) according to manufacturers' instructions for the respective study lesion; in addition to general caries preventive measures (standard-oral care hygiene treatment, diet counselling and fluoride regimen). | 130 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study was terminated due to insufficient recruitment before 36 month follow up could be completed | 56 |
Baseline characteristics
| Characteristic | Resin Infiltration / Mock Treatment (Split-mouth; Participants With Paired Lesions) |
|---|---|
| Age, Categorical <=18 years | 13 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 30 years |
| Caries Risk (CR) High Caries Risk (67%<CR) | 0 Participants |
| Caries Risk (CR) Low Caries Risk (CR<33%) | 17 Participants |
| Caries Risk (CR) Moderate Caries Risk (34%<CR<66%) | 39 Participants |
| Lesion size Mock treatment group D1 | 10 Lesions |
| Lesion size Mock treatment group D2 | 0 Lesions |
| Lesion size Mock treatment group E1 | 42 Lesions |
| Lesion size Mock treatment group E2 | 13 Lesions |
| Lesion size Resin infiltration group D1 | 12 Lesions |
| Lesion size Resin infiltration group D2 | 0 Lesions |
| Lesion size Resin infiltration group E1 | 40 Lesions |
| Lesion size Resin infiltration group E2 | 13 Lesions |
| Race/Ethnicity, Customized African American | 19 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 32 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants |
| Race/Ethnicity, Customized Two ethnicities (Asian and Hispanic) | 1 Participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
Number of Invasive Interventions (Fillings)
Cumulative number of study lesions that have progressed to a state were an invasive intervention (filling) has been required to restore the teeth as determined via an dental examination (baseline versus 3 year follow up).
Time frame: 3 years
Population: This study was terminated. The 3 year follow up was not reached for any enrolled participant at the time of termination.
Secondary
Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling)
Change in categorical lesion depth (progression to next depth category lesion; E1-\>E2-\>D1-\>D2-\>filling) as measured by pairwise comparison of radiographs (baseline versus follow up time point). E1 (lesion within the outer half of enamel), E2 (inner half of enamel), D1 (outer third of dentin), D2 (middle third of dentin). Reference: Anusavice K. Present and future approaches for the control of caries. J Dent Educ. 2005;69(5):538-854.
Time frame: 6 months and 12 months
Population: The intended follow up time frame was 6, 12, 24 and 36 months. However, due to the termination of the study, only the 6 and 12 month follow ups were completed for the enrolled participants.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Resin Infiltration | Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling) | Progressed lesions at 6 month follow up | 3 Lesions |
| Resin Infiltration | Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling) | Progressed lesions at 12 month follow up | 7 Lesions |
| Mock Treatment | Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling) | Progressed lesions at 6 month follow up | 6 Lesions |
| Mock Treatment | Number of Lesions That Changed in Size (E1->E2->D1->D2-> Filling) | Progressed lesions at 12 month follow up | 9 Lesions |
Other Pre-specified
Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response
Teeth included in the study were clincially assed for sensitivity to percussion, papillary bleeding, cold response.
Time frame: 6 months and 12 months
Population: The intended follow up time frame was 6, 12, 24 and 36 months. However, due to the termination of the study, only the 6 and 12 month follow ups were completed for the enrolled participants.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Resin Infiltration | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Papillary bleeding at 12 months | 4 Lesions |
| Resin Infiltration | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Cold response at 12 months | 0 Lesions |
| Resin Infiltration | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Papillary bleeding at 6 months | 19 Lesions |
| Resin Infiltration | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Sensitivity to percussion at 6 months | 0 Lesions |
| Resin Infiltration | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Cold response at 6 months | 1 Lesions |
| Resin Infiltration | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Sensitivity to percussion at 12 months | 0 Lesions |
| Mock Treatment | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Cold response at 6 months | 0 Lesions |
| Mock Treatment | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Papillary bleeding at 6 months | 18 Lesions |
| Mock Treatment | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Papillary bleeding at 12 months | 4 Lesions |
| Mock Treatment | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Sensitivity to percussion at 12 months | 0 Lesions |
| Mock Treatment | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Cold response at 12 months | 1 Lesions |
| Mock Treatment | Number of Lesions With Sensitivity to Percussion, Papillary Bleeding, Cold Response | Sensitivity to percussion at 6 months | 0 Lesions |