Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.

Detailed Description
-----------------
The sample will be comprised of 141 patients between 3 to 10 year-old and 504 proximal surfaces of 12-to-17-year-old adolescents, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.

Official Title
-----------------
Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth: a Randomized Placebo-controlled Study.

Conditions
-----------------
Dental Caries, Compliance Behavior

Intervention / Treatment
-----------------
* Procedure: Resin Infiltration
* Procedure: 30% Silver Diammine Fluoride
* Procedure: Dental Flossing
* Procedure: Resin Infiltration Placebo
* Procedure: 30% Silver Diammine Fluoride Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary teeth: distal surface of the first molar, mesial surface of the second molar and distal surface of the second molar (when the first permanent molar is present) with initial caries lesion (ICDAS 1, 2 or 3). Permanent teeth: distal surface of the first premolar, mesial surface of the second premolar, distal surface of the second premolar, mesial surface of the first molar, distal surface of the first molar and mesial surface of the second molar with initial caries lesion (ICDAS 1, 2 or 3). Exclusion Criteria: Mesial surface of the first primary molar/premolar by the smaller contact with the distal surface of the canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 17 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resin Infiltration<br>Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing | Procedure: Resin Infiltration<br>* After cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion. The resin will be polymerized and applied again and polymerized.<br>* Other names: Icon;Procedure: Dental Flossing<br>* In this group, the patient will perform only mechanical removal of biofilm to floss daily.<br>* Other names: Oral hygiene;Procedure: 30% Silver Diammine Fluoride Placebo<br>* Soft tissues will be protected with petroleum jelly. The patient will receive sterile water application with a disposable microbrush for 3m. Then the surface will be washed for 30s.<br>* Other names: Cariestop Placebo;|
| Experimental: 30% Silver Diammine Fluoride<br>30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing | Procedure: 30% Silver Diammine Fluoride<br>* It will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.<br>* Other names: Cariestop;Procedure: Dental Flossing<br>* In this group, the patient will perform only mechanical removal of biofilm to floss daily.<br>* Other names: Oral hygiene;Procedure: Resin Infiltration Placebo<br>* In this group, the patient will be held only inserting the rubber dam and applied sterile water as a substitute for acid, ethanol and resin infiltration.<br>* Other names: Icon Placebo;|
| Active Comparator: Oral Hygiene<br>Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo | Procedure: Dental Flossing<br>* In this group, the patient will perform only mechanical removal of biofilm to floss daily.<br>* Other names: Oral hygiene;Procedure: Resin Infiltration Placebo<br>* In this group, the patient will be held only inserting the rubber dam and applied sterile water as a substitute for acid, ethanol and resin infiltration.<br>* Other names: Icon Placebo;Procedure: 30% Silver Diammine Fluoride Placebo<br>* Soft tissues will be protected with petroleum jelly. The patient will receive sterile water application with a disposable microbrush for 3m. Then the surface will be washed for 30s.<br>* Other names: Cariestop Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression of initial lesion caries |  | 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| approximal plaque reduction |  | 1, 3, 6, 12, 18 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental caries, primary teeth, permanent teeth, silver diamine fluoride