Two Preventive Measures on Caries Progression in Mixed Dentition Patients.

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

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.

Study Overview

• Status: Completed
• Conditions: Dentist's Role
• Intervention / Treatment: Device: Diode Laser; Drug: SDF1; Drug: Pit Fissure Sealant

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry British University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: British University In Egypt
• Investigators: Study Director: Noha Kabil, Professor, Head of Department; Study Director: Basma Gamal, Lecturer, Faculty Council Member

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: permanent molars; SDF; primary molars; Diode Laser; Pits and fissure sealants
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: PED 20-3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes