Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531148
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
A Clinical and Microbiological Assessment of the Efficacy of Chemo-mechanical Caries Removal Versus Conventional Caries Removal Methods in Children Randomized Controlled Clinical Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None