Clinical trial NCT06902532: Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children
Official title: Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Keywords: Tooth Decay Streptococcus Mutans Oil Pulling Coconut Oil Clove Oil Fluoride Mouthwash Pediatric Dentistry Oral Hygiene
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 105
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a parallel group randomized controlled trial design with three intervention arms: coconut oil pulling with clove oil, coconut oil pulling alone, and fluoride mouthwash (control). The study evaluates the impact on Streptococcus mutans count in children.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 1.Children aged 6-12 years old. 2.Both male and female participants. 3.Patients in good general health condition with no systemic disease. 4.Patients' first guardians must provide written informed consent to participate in the study

Exclusion Criteria:

* 1.Patients who have recently received fluoride treatments (within the last 2 weeks).

  2.Patients with a history of recent antibiotic administration (within the last 2 weeks).

  3.Patients who have recently used antimicrobial mouth rinses in the last 12 hours or topical fluoride treatments.

Primary outcomes:
measure: streptococcus mutans count
timeFrame: Baseline (T0), immediately after intervention (T1), and after 4 weeks (T2).
Secondary outcomes:
Other outcomes:
Locations:
city: Egypt
country: Egypt
facility: Faculty of Dentistry Cairo university
state: Cairo
city: Cairo
country: Egypt
facility: Faculty of Dentistry-Cairo university
Study officials:
affiliation: Cairo University
name: nada wassef main supervisor, associate professor
role: STUDY_DIRECTOR
References: