Dental Caries
Conditions
Keywords
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy
Brief summary
This study is investigating the efficacy of caries lesion infiltration therapy as compared to the current preventative approach for early caries lesions.
Detailed description
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.
Interventions
DEVICEResin infiltration
Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy
BEHAVIORALCaries management
Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements
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
14 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* 14-35 year old subjects * decayed-missing-filled permanent teeth (DMFT) ≥ 3 * having at least two early caries lesions in approximal posterior tooth surfaces * lesion 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 Showing Radiographic Progression as Measured by Lesion Size (Continuous) | Baseline through 3 years | Pairwise radiographic assessment of lesion progression: combined visual assessment (PWA) and digital subtraction radiography (DSR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories | Baseline through 3 years | Radiographic assessment of lesion depth category (R1-R5) by single radiograph assessment (SRA). |
| Lesion Survival After 3 Years | 3 years | Discrete time survival analysis of time to first lesion progression. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Lesion Infiltration and Preventative Management Only |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 21.1 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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).
Time frame: Baseline through 3 years
Population: Pairwise assessment: visual (PWA) + digital subtraction radiography (DSR).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lesion Infiltration | Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) | 2 Lesions |
| Preventative Measures | Number of Lesions Showing Radiographic Progression as Measured by Lesion Size (Continuous) | 11 Lesions |
p-value: 0.002Regression, Logistic
Secondary
Lesion Survival After 3 Years
Discrete time survival analysis of time to first lesion progression.
Time frame: 3 years
Population: Radiographic lesion increase by PWA+DSR. A tooth was included up until the time the lesion first increased.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lesion Infiltration | Lesion Survival After 3 Years | 11 Lesions |
| Preventative Measures | Lesion Survival After 3 Years | 3 Lesions |
p-value: 0.0077Discreet Time Survival Analysis
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).
Time frame: Baseline through 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lesion Infiltration | Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories | 2 Lesions |
| Preventative Measures | Number of Lesions Showing Radiographic Progression as Measured by Lesion Depth Categories | 9 Lesions |
p-value: 0.045Regression, Logistic