NCT06531148

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Chemo-Mechanical Caries Removal

Interventions

Type	Name	Description
OTHER	Chemo-mechanical caries removal	Chemo-mechanical were be used as a Chemo-mechanical caries removal agent for one side of the bilateral carious teeth (selected randomly). Application of the material were be done according to the manufacturer's instructions (20). The material will be applied with a blunt spoon excavator and left for 2 minutes allowing the chemistry to work. The decayed dentin which becomes soft (due to the action of the material) was being scraped away using a blunt excavator in a pendulum movement without pressure. If necessary, the procedure will be repeated to get healthy dentin. The cavity will be visually inspected by caries detector dye to assess the complete removal of the carious dentin.

Timeline

• Start date: 2024-07-31
• Primary completion: 2024-10-02
• Completion: 2024-11-11
• First posted: 2024-07-31
• Last updated: 2024-07-31

Locations

2 sites across 1 country: Egypt