Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10-PAF03721 | Other Identifier | U-Michigan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| DMG Dental Material Gesellschaft mbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.
A 3-year longitudinal, prospective, randomized control clinical trial (RCT) is designed incorporating a split-mouth intra-oral design. Young volunteers (14-35 years old) with at least two early lesions in posterior teeth will be enrolled into this clinical trial to evaluate the clinical effectiveness of arresting lesion progression by infiltrating the lesions. The infiltration protocol included application of on-market materials and applicators, and was performed in one session.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preventative measures | Placebo Comparator | Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation |
|
| Lesion infiltration | Active Comparator | Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin infiltration | Device | Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) | Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR). | Baseline through 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories | Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA). | Baseline through 3 years |
| Lesion Survival After 3 Years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mathilde C Peters, DMD, PhD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Peters MC, Tuzzio F, Nedley M, Davis W, Bayne SC. Resin Infiltration Effects In A Caries-Active Environment. J Dent Res 92(Spec Iss A):377, 2013. | ||
| 25080756 | Result | Resin infiltration effects in a caries-active environment. J Calif Dent Assoc. 2014 Jun;42(6):372. No abstract available. | |
| Result | Peters MC, Bula A, Nedley M, Davis W, Bayne SC. Efficacy of Resin Infiltration in High Caries-Active Environment -- 3YR Results. J Dent Res 93(Spec Iss B): 1017, 2014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Paired, split-mouth study design: Each patient received at least 1 pair of 2 treatments (one of each arm). Eligible tooth pairs selected for similarity. Random allocation of treatment to study teeth of each tooth pair.
Recruitment was not as expected and halted after one year. Local options to enhance patient accrual were exhausted. The total patient pool was small, but of sufficient scientific value to continue and complete the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lesion Infiltration and Preventative Management Only | Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth). A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only. --- Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled: 17 patients; 1 patient was not treated according to protocol. Baseline: 16 patients with 22 tooth pairs.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lesion Infiltration and Preventative Management Only | Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) | Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR). | Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR). | Posted | Number | Lesions | Baseline through 3 years | Lesions | Lesions |
|
Baseline through 3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lesion Infiltration | Resin infiltration of caries lesion in addition to SOC caries management by preventative measures SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements |
Not provided
Not provided
Small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mathilde C Peters | UMichigan | mcpete@umich.edu |
Not provided
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Caries management | Behavioral | Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements |
|
|
Discrete time survival analysis of time to first lesion progression.
| 3 years |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories | Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA). | Posted | Number | Lesions | Baseline through 3 years | Lesions | Lesions |
|
|
|
|
| Secondary | Lesion Survival After 3 Years | Discrete time survival analysis of time to first lesion progression. | Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased. | Posted | Number | Lesions | 3 years | Lesions | Lesions |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Preventative Measures | Caries management by preventative measures only SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements | 0 | 16 | 0 | 16 |
Not provided
Not provided
Not provided