Clinical trial

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

Name
PED 20-3D
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. Secondary Objective: Effect of SDF and Laser Application on the subsequently applied pits and fissure sealants.
Trial arms
Trial start
2020-06-01
Estimated PCD
2023-06-01
Trial end
2023-10-01
Status
Completed
Phase
Early phase I
Treatment
SDF1
Topical SDF application
Arms:
Group B, Group D
Other names:
silver diamine fluoride
Diode Laser
Irradiating Enamel by Diode laser
Arms:
Group A, Group C
Other names:
Class 4 dental laser
Pit Fissure Sealant
Sealing occlusal pits and fissures
Arms:
Group C, Group D
Other names:
PFS
Size
23
Primary endpoint
Number of molars with arrested initial decay
1 year follow up
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 23, 'type': 'ACTUAL'}}
Updated at
2023-11-07

1 organization

2 products

1 indication

Product
SDF1
Indication
Dentist's Role