A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Chemo-Mechanical Caries Removal

• Registration Number: NCT06531148
• Lead Sponsor: Mansoura University

Brief Summary

This study will be conducted to Assess the clinical and microbiological efficacy of chemomechanical caries removal (CarieMove® Gel) versus conventional excavation method in children.

The assessed parameters will be:

* Efficacy of caries removal.

* Pain reaction and mean time required for the treatment.

* Total bacterial count before and after treatment.

Detailed Description

Subjects:

A total of 30 children 7-9 years old with no history of systematic disease will be recruited from the out-patient pediatric dental clinic, Faculty of Dentistry, Mansoura University.

Each child with the following criteria will be eligible for the present study (22).

Inclusion criteria:

1. Cooperative child

2. Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.

3. The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.

4. The selected molars should have normal structure and morphology.

Exclusion criteria:

1. Un-cooperative child

2. Molars with clinical and radiographic signs of pulp involvement.

3. Children with special health care needs.

4. Molars which have already been restored or have developmental anomaly.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study Start: 2024-07-31
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-10-02
• Study Completion: 2024-11-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Cooperative child
2. Each child has two bilateral first permanent molars with simple Class 1 occlusal caries involving dentin.
3. The carious first permanent molars are free from clinical and radiographic evidence of pulp involvement.
4. The selected molars should have normal structure and morphology.

Exclusion Criteria

• 1- Un-cooperative child 2- Molars with clinical and radiographic signs of pulp involvement. 3- Children with special health care needs. 4- Molars which have already been restored or have developmental anomaly.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical evaluation	11.2 ± 3.3 min	A-Efficacy: B- Child satisfaction and pain experience: C-Time assessment

Trial Locations

Locations (1)

Dentistry; 🇪🇬 Mansoura, Egypt