Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-01 @ 11:51 AM
Study NCT ID:
NCT06902532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPCO
Brief Summary:
This study aims to compare the effectiveness of coconut oil pulling with clove oil, coconut oil pulling alone, and fluoride mouthwash in reducing Streptococcus mutans levels in children aged 6-12 years. Participants will be randomly assigned to one of three groups:
1. Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil.
2. Coconut Oil Pulling Group - Daily swishing with coconut oil alone.
3. Fluoride Mouthwash Group (Control) - Using fluoride mouthwash as per standard guidelines.
The primary outcome is the reduction in Streptococcus mutans count, assessed through microbiological analysis of saliva samples at baseline, immediately after intervention, and after 4 weeks. Secondary outcomes include patient acceptability, adherence, and gingival health.
This randomized controlled trial will provide insight into natural alternatives for oral health maintenance in children.
Study Location: Cairo University, Faculty of Dentistry. Estimated Study Duration: May 2025 - January 2026.
1. Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil.
2. Coconut Oil Pulling Group - Daily swishing with coconut oil alone.
3. Fluoride Mouthwash Group (Control) - Using fluoride mouthwash as per standard guidelines.
The primary outcome is the reduction in Streptococcus mutans count, assessed through microbiological analysis of saliva samples at baseline, immediately after intervention, and after 4 weeks. Secondary outcomes include patient acceptability, adherence, and gingival health.
This randomized controlled trial will provide insight into natural alternatives for oral health maintenance in children.
Study Location: Cairo University, Faculty of Dentistry. Estimated Study Duration: May 2025 - January 2026.
Detailed Description:
This study is a three-arm, randomized controlled trial assessing the impact of coconut oil pulling with clove oil compared to coconut oil alone and fluoride mouthwash on Streptococcus mutans reduction in children. Participants will be recruited from the Pediatric Dentistry Department at Cairo University and randomly assigned using a 1:1:1 allocation ratio.
Saliva samples will be collected at three time points (baseline, immediately after intervention, and 4 weeks post-intervention) for microbiological analysis. The study will also evaluate secondary outcomes such as patient compliance (measured using the MMAS-4 scale), acceptability (using a 5-point Likert scale), and gingival health (assessed with the Löe \& Silness Gingival Index).
The findings aim to determine whether natural oil-based methods can serve as effective, non-invasive alternatives to fluoride-based mouth rinses in pediatric populations.
Saliva samples will be collected at three time points (baseline, immediately after intervention, and 4 weeks post-intervention) for microbiological analysis. The study will also evaluate secondary outcomes such as patient compliance (measured using the MMAS-4 scale), acceptability (using a 5-point Likert scale), and gingival health (assessed with the Löe \& Silness Gingival Index).
The findings aim to determine whether natural oil-based methods can serve as effective, non-invasive alternatives to fluoride-based mouth rinses in pediatric populations.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| self funded study | OTHER | Cairo university-faculty of dentistry | View |