Radiographic Progression of Infiltrated Caries Lesions In-vivo

Study Overview
=================
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.

Official Title
-----------------
Radiographic Progression of Infiltrated Caries Lesions In-vivo

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Device: Resin infiltration
* Behavioral: Caries management


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Preventative measures<br>Caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation | Behavioral: Caries management<br>* Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements<br>* Other names: Home use of over-the-counter oral health products;|
| Active Comparator: Lesion infiltration<br>Resin infiltration of caries lesion in addition to caries management by preventative measures of oral hygiene instruction, diet counseling and fluoride supplementation | Device: Resin infiltration<br>* Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy<br>* Other names: ICON (DMG, Germany);Behavioral: Caries management<br>* Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements<br>* Other names: Home use of over-the-counter oral health products;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Discrete time survival analysis of time to first lesion progression. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental caries, Proximal surfaces, Posterior teeth, Carious lesions, Tooth diseases, Preventive therapy