NCT06531148
Not yet recruiting
Not Applicable
A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children: Randomized Controlled Clinical Trial
ConditionsChemo-Mechanical Caries Removal
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Mansoura University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Clinical evaluation
Overview
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:
- 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.
Exclusion criteria:
- Un-cooperative child
- Molars with clinical and radiographic signs of pulp involvement.
- Children with special health care needs.
- Molars which have already been restored or have developmental anomaly.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Clinical evaluation
Time Frame: 11.2 ± 3.3 min
A-Efficacy: B- Child satisfaction and pain experience: C-Time assessment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Unknown
Not Applicable
Microbiological Assessment After Chemo-Mechanical Caries Removal Using Papain-based Enzyme Versus Conventional Rotary Tools in Occlusal Carious LesionsMicrobial ColonizationNCT03408626Cairo University2
Not yet recruiting
Phase 2
Clinical and microbiological effectiveness of herbal gum astringent after scaling in gingivitis patientsHealth Condition 1: K050- Acute gingivitisCTRI/2022/04/041627Purexa Global Pvt Ltd
Completed
Not Applicable
Mechanical Vs Chemomechanical Method For Calcium Hydroxide RemovalNecrotic PulpChronic Apical PeriodontitisNCT05744661Pakistan Institute of Medical Sciences60
Completed
Phase 2
Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic PeriodontitisChronic PeriodontitisNCT02013323Government Dental College and Research Institute, Bangalore60
Completed
Phase 3
Clinical and bacteriological Effects of Synbiotic as an Adjunct in Phase I Periodontal TherapyChronic periodontitis.Chronic periodontitisK05.3IRCT20130216012487N7Esfahan University of Medical Sciences28