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

NCT06531148 | Unknown

• 1 other identifier: A0303023PP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chemo-Mechanical Caries Removal

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation

  A-Efficacy: B- Child satisfaction and pain experience: C-Time assessment

  11.2 ± 3.3 min

Study Arms (2)

Chemo-mechanical caries removal

EXPERIMENTAL

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

Other: Chemo-mechanical caries removal

Conventional drilling method

OTHER

* 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.

Other: Chemo-mechanical caries removal

Interventions

Chemo-mechanical caries removal OTHER

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.

Chemo-mechanical caries removal; Conventional drilling method

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (2)

Dentistry

Al Mansurah, El-dahlewa, 35516, Egypt

Location

Dentistry

Al Mansurah, 35516, Egypt

Location

Central Study Contacts

Mutasim Babiker Elbashir, Master

CONTACT

800-555-5555; dr.mutasimbabiker@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a randomized controlled clinical trial with split-mouth technique

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: July 31, 2024
• Primary Completion: October 2, 2024
• Study Completion: November 11, 2024
• Last Updated: July 31, 2024

Record last verified: 2023-10

Locations

EG (2)