Two Preventive Measures on Caries Progression in Mixed Dentition Patients.

Phase 2

Completed

• Conditions: Dentist's Role
• Interventions: Device: Diode Laser; Drug: SDF1; Drug: Pit Fissure Sealant

• Registration Number: NCT06119126
• Lead Sponsor: British University In Egypt

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-10-01
• Study First Submitted: 2023-10-29
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-05
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Diode Laser	Diode laser application followed by pits and fissure sealant.
Group C	Pit Fissure Sealant	Diode laser application followed by pits and fissure sealant.
Group A	Diode Laser	Diode laser application only
Group D	SDF1	SDF application followed by pits and fissure sealant.
Group B	SDF1	SDF application only
Group D	Pit Fissure Sealant	SDF application followed by pits and fissure sealant.

Primary Outcome Measures

Name	Time	Method
Number of molars with arrested initial decay	1 year follow up	ICDAS II Score system

Secondary Outcome Measures

Name	Time	Method
Number of molars with completely retained f pits and fissure sealants	1 year follow up	Simonsen's Criteria

Trial Locations

Locations (1)

Faculty of Dentistry British University; 🇪🇬 Cairo, Egypt