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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531148
Enrollment
30
Registered
2024-07-31
Start date
2024-07-31
Completion date
2024-11-11
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemo-Mechanical Caries Removal

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.

Interventions

OTHERChemo-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.

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Intervention model description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical evaluation11.2 ± 3.3 minA-Efficacy: B- Child satisfaction and pain experience: C-Time assessment

Countries

Egypt

Contacts

Primary ContactMutasim Babiker Elbashir, Master
dr.mutasimbabiker@gmail.com800-555-5555

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026