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

Mansoura University

Status: Not yet enrolling

Conditions: Chemo-Mechanical Caries Removal

Treatments: Other: Chemo-mechanical caries removal

Study type: Interventional

Funder types: Other

Identifiers

NCT06531148

A0303023PP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Chemo-mechanical caries removal

Experimental group

Description:

A Chemo-mechanical caries removal agent for one side of the bilateral carious teeth (selected randomly). Application of the material will be done according to the manufacturer's instructions

Treatment:

Other: Chemo-mechanical caries removal

Conventional drilling method

Other group

Description:

* In this group, caries removal was performed using a low-speed handpiece with a carbon steel round bur. * The cavities were then examined using the same criteria that had been used with Group I to assess for any remaining caries. * After caries removal, a dentin sample was taken from the cavity floor in both groups using a sterile sharp spoon excavator. * The dentin sample was transported to a sterile screw-cap vial for bacterial count examination.

Treatment:

Other: Chemo-mechanical caries removal