Two Preventive Measures on Caries Progression in Mixed Dentition Patients.

Study Overview
=================
Brief Summary
-----------------
Primary Objective: Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars. Secondary Objective: Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.

Detailed Description
-----------------
Primary Objective: Assessing the clinical effect of SDF and Laser on the prevention of initial caries progression with and without pits and fissure sealants in both permanent and primary molars. Scoring caried out by ICDAS Scoring criteria over a 1 year follow up period Secondary Objective: Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants. Measured by Simonson's criteria over 1 year follow up period.

Official Title
-----------------
Clinical Efficacy of SDF and Laser in Preventing Initial Caries Progression With and Without Fissure Sealants in Primary and Permanent Molars

Conditions
-----------------
Dentist's Role

Intervention / Treatment
-----------------
* Drug: SDF1
* Device: Diode Laser
* Drug: Pit Fissure Sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria .Children aged 6-9 years old. .Patients categorized as moderate to high caries risk (deft index >1) showing more than 1 new carious lesions or restorations in the last 36 months according to ADA Caries Risk Assessment Form (Age >6) .A split mouth study design was followed where all four second molars were selected for intervention in the primary molar group, while all first molars were selected for intervention in the permanent molar group. .The four molars selected in each patient (primary / permanent) should be fully erupted with no gingival overhangs /operculum and with no history of previous restorations or prior sealants. .According to International Caries Detection and Assessment System ICDAS grading, molars with (0, 1, 2) scores only were included. Exclusion Criteria: .Uncooperative or mentally challenged patients, with bad oral hygiene or rampant caries. .Patients providing history of bruxism or clenching affecting the posterior occlusion were excluded. .Children with known allergies or sensitivities to resins or silver products. .Molars that showed well-coalesced, self-cleansing pits & fissures or shallow grooves and severe forms of hypoplasia / fluorosis were excluded. .Patients & parents with high esthetic demands and concerns. .Unmotivated patients, or parents who refused to sign the consent form.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Diode laser application only | Device: Diode Laser<br>* Irradiating Enamel by Diode laser<br>* Other names: Class 4 dental laser;|
| Experimental: Group B<br>SDF application only | Drug: SDF1<br>* Topical SDF application<br>* Other names: silver diamine fluoride;|
| Experimental: Group C<br>Diode laser application followed by pits and fissure sealant. | Device: Diode Laser<br>* Irradiating Enamel by Diode laser<br>* Other names: Class 4 dental laser;Drug: Pit Fissure Sealant<br>* Sealing occlusal pits and fissures<br>* Other names: PFS;|
| Experimental: Group D<br>SDF application followed by pits and fissure sealant. | Drug: SDF1<br>* Topical SDF application<br>* Other names: silver diamine fluoride;Drug: Pit Fissure Sealant<br>* Sealing occlusal pits and fissures<br>* Other names: PFS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of molars with arrested initial decay | ICDAS II Score system | 1 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of molars with completely retained f pits and fissure sealants | Simonsen's Criteria | 1 year follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SDF, Diode Laser, Pits and fissure sealants, primary molars, permanent molars