Dental Caries
Conditions
Keywords
Tooth Decay Streptococcus Mutans Oil Pulling Coconut Oil Clove Oil Fluoride Mouthwash Pediatric Dentistry Oral Hygiene
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.
Interventions
BEHAVIORALcoconut oil pulling with clove oil
Participants will swish 10 mL of coconut oil mixed with 2 drops of clove oil once daily for 4 weeks. This intervention is designed to assess its antimicrobial efficacy in reducing Streptococcus mutans levels in children and improving oral hygiene.
BEHAVIORALcoconut oil pulling
Participants will swish 10 mL of pure coconut oil once daily for 4 weeks. This intervention aims to evaluate the effectiveness of coconut oil alone in reducing Streptococcus mutans levels and its potential role in maintaining oral health.
Participants will rinse with 10 mL of fluoride mouthwash three times daily for 4 weeks. This intervention serves as the active comparator, as fluoride mouthwash is a well-established method for reducing Streptococcus mutans levels and preventing dental caries.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This study will implement triple blinding, where the participants, investigator, and outcome assessors will be unaware of group allocations to reduce bias in results.
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| streptococcus mutans count | Baseline (T0), immediately after intervention (T1), and after 4 weeks (T2). | The primary outcome of this study is the reduction in Streptococcus mutans count in plaque samples collected from participants. Samples will be collected at three time points: baseline (T0), immediately after the intervention (T1), and four weeks post-intervention (T2). The bacterial count will be analyzed using Mitis Salivarius Bacitracin (MSB) Agar and expressed as colony-forming units per milliliter (CFU/mL). The count will be manually determined using a colony counter after incubation under anaerobic conditions for 24-72 hours at 37°C. Gram staining, catalase test, and sugar fermentation tests will be performed to confirm the presence of Streptococcus mutans |
Countries
Egypt
Contacts
Primary Contactkholoud shaaban principle investigator, BDS
Outcome results
None listed