Dental Caries
Conditions
Keywords
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy
Brief summary
The purpose of this study is to determine whether lesion infiltration is an effective management strategy to arrest early tooth decay.
Detailed description
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.
Interventions
DEVICEResin infiltration
Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification. ICON product: FDA-510(k): K100062
DEVICESham treatment
Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.
Sponsors
DMG Dental Material Gesellschaft mbH
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
No
Inclusion criteria
* DMFT ≥ 3 (DMFT = index of decayed-missing-filled permanent teeth) * Having at least two early caries lesions in approximal posterior tooth surfaces * Lesions visible on radiograph
Exclusion criteria
* Current participation in another clinical study * Medically compromised subjects * Hyposalivation * Pregnancy * Allergic to methylmethacrylates * Allergic to latex * Symptomatic teeth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) | 3 Years | Cumulative lesion progression as measured by PW comparison of radiographs (baseline versus 3 year) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Progression as Measured by Depth Category (N=Lesions) | 3 Years | 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). |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Paired Lesions: Resin Infiltration / Control Within-person study: both arms were applied in same participant (2 study teeth/lesions per person). | 42 |
| Participants With Paired Lesions: Resin Infiltration / Control Within-person study: both arms were applied in same participant (2 study teeth/lesions per person). | 84 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Participants With Paired Lesions: Resin Infiltration / Control |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age, Continuous | 20.1 years STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Lesions with Progression | 58 Lesions |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Region of Enrollment United States | 42 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
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)
Time frame: 3 Years
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Resin Infiltration | Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) | 4 Lesions |
| Control | Number of Lesions With Progression as Measured by Pairwise (PW) Comparison (N=Lesions) | 14 Lesions |
p-value: =0.003McNemar
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).
Time frame: 3 Years
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Resin Infiltration | Number of Lesions With Progression as Measured by Depth Category (N=Lesions) | 3 Lesions |
| Control | Number of Lesions With Progression as Measured by Depth Category (N=Lesions) | 7 Lesions |
p-value: =0.17McNemar