A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
NCT ID: NCT06531148
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2024-07-31
2024-11-11
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Chemo-mechanical caries removal
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
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.
Conventional drilling method
* 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Locations
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Dentistry
Al Mansurah, El-dahlewa, Egypt
Dentistry
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Mutasim Babiker Zainelabdin Elbashir, Master
Role: primary
Master
Role: backup
Other Identifiers
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A0303023PP
Identifier Type: -
Identifier Source: org_study_id