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| ID | Type | Description | Link |
|---|---|---|---|
| 12-PAF02598 | Other Identifier | U-Michigan |
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| Name | Class |
|---|---|
| DMG Dental Material Gesellschaft mbH | INDUSTRY |
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The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.
A 3-year prospective, randomized control clinical trial (RCT) is designed incorporating a split mouth intra-oral design. Young volunteers (18-24 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 resin infiltration therapy as adjunct to standard-of-care preventative measures. Lesion status (non-cavitated) is clinically confirmed prior to implementing the assigned therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resin infiltration | Active Comparator | Resin infiltration of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) |
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| Control | Sham Comparator | Sham treatment of early caries lesion in addition to preventative measures (oral hygiene, diet counseling, repeated fluoride varnish application) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resin infiltration | Device | Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) | Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year) | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lesions With Progression as Measured by Depth Category (N=Lesions) | Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr). | 3 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mathilde C Peters, DMD, PhD | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saunders USADC | West Point | New York | 10996 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31526071 | Derived | Peters MC, Hopkins AR Jr, Zhu L, Yu Q. Efficacy of Proximal Resin Infiltration on Caries Inhibition: Results from a 3-Year Randomized Controlled Clinical Trial. J Dent Res. 2019 Dec;98(13):1497-1502. doi: 10.1177/0022034519876853. Epub 2019 Sep 16. |
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Paired, split-mouth study design: Each patient received 2 paired treatments (one of each arm). Eligible tooth pairs were selected for similarity. Random allocation of treatment to study lesions per tooth pair.
Caries-active volunteer cadet-candidates and cadets, at high risk for caries disease, were recruited at United States Military Academy in West-Point, New York (USA).
| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Paired Lesions: Resin Infiltration / Control | Within-person study: both arms were applied in same participant (2 study teeth/lesions per person). Resin infiltration (test) or Sham Treatment (control) of two paired carious lesions in addition to preventative measures and behavioral modification. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Analysis populations are single and paired lesions
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Paired Lesions: Resin Infiltration / Control | Within-person study: both arms were applied in same participant (2 study teeth/lesions per person). |
| Units | Counts |
|---|---|
| Participants |
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| 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 With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) | Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year) | Posted | Count of Units | Lesions | 3 Years | Lesions | Lesions |
|
Baseline through 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Paired Lesions: Resin Infiltration / Control | Within-person study: both arms were applied in same participant (2 study teeth/lesions per person). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mathilde Peters (PI) | University of Michigan | 734-925-2750 | mcpete@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2011 | Dec 22, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D009057 | Stomatognathic Diseases |
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| Sham treatment | Device | Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification. |
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| Lesions |
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| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| Number of Lesions with Progression | Lesion progression is measured by assessment of single radiographs (using depth categories) and pairwise comparison of radiographs over time (continuous progression) | Count of Units | Lesions | Lesions |
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| Units | Counts |
|---|---|
| Participants |
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| Lesions |
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| Secondary | Number of Lesions With Progression as Measured by Depth Category (N=Lesions) | Radiographic lesion depth categories: E2 (inner enamel), D1 (outer dentin) and D2-rest (middle dentin or restored). Lesion depth assessment on single radiograph (baseline, 3 yr). | Posted | Count of Units | Lesions | 3 Years | Lesions | Lesions |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
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