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NCT Number: NCT06902532

Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry-Cairo university, Cairo, Cairo Governorate, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

coconut oil pulling with clove oil

Behavioral

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.

coconut oil pulling

Behavioral

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.

Fluoride Mouthwash

Drug

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.

Primary outcomes

  1. streptococcus mutans count

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

kholoud shaaban principle investigator, BDS

CONTACT

[email protected]

0201007548590

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: COPCO

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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