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

NCT ID: NCT06902532

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-01-01

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Arm 1: → Coconut Oil Pulling with Clove Oil

Arm 1: Coconut Oil Pulling with Clove Oil

Arm Description:

Participants in this group will swish 10 mL of coconut oil mixed with 2 drops of clove oil once daily for 4 weeks. The aim is to evaluate its effect on reducing Streptococcus mutans levels in children.

Group Type: EXPERIMENTAL

coconut oil pulling with clove oil

Intervention Type: 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.

Arm 2: → Coconut Oil Pulling

Arm 2: Coconut Oil Pulling

Arm Description:

Participants in this group will swish 10 mL of pure coconut oil once daily for 4 weeks. This arm assesses the impact of coconut oil alone on Streptococcus mutans reduction in children.

Group Type: EXPERIMENTAL

coconut oil pulling

Intervention Type: 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.

Arm 3: → Fluoride Mouthwash

Arm 2: Coconut Oil Pulling

Arm Description:

Participants in this group will swish 10 mL of pure coconut oil once daily for 4 weeks. This arm assesses the impact of coconut oil alone on Streptococcus mutans reduction in children.

Group Type: ACTIVE_COMPARATOR

Fluoride Mouthwash

Intervention Type: 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.

Interventions

coconut 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.

Intervention Type: BEHAVIORAL

coconut 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.

Intervention Type: BEHAVIORAL

Fluoride Mouthwash

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Kholoud shaaban abdelmonaem mohamed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nada wassef main supervisor, associate professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of Dentistry-Cairo university

Cairo, Cairo Governorate, Egypt

Faculty of Dentistry Cairo university

Egypt, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

kholoud shaaban principle investigator, BDS

Role: CONTACT

kholoud.shaaban@dentistry.cu.edu.eg

0201007548590

Facility Contacts

kholoud shaaban principle investigator, BDS

Role: primary

021007548590

kholoud shaaban principle investigator, BDS

Role: primary

kholoud.shaaban@dentistry.cu.edu.eg

0201007548590

Other Identifiers

self funded study

Identifier Type: OTHER

Identifier Source: secondary_id

COPCO-2025

Identifier Type: -

Identifier Source: org_study_id