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

NCT06902532 | Not Yet Recruiting DMC

• 2 other identifiers: COPCO-2025self funded study
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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. 1.Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil.
2. 2.Coconut Oil Pulling Group - Daily swishing with coconut oil alone.
3. 3.Fluoride Mouthwash Group (Control) - Using fluoride mouthwash as per standard guidelines.

Conditions

Dental Caries

Keywords

Tooth Decay Streptococcus Mutans Oil Pulling Coconut Oil Clove Oil Fluoride Mouthwash Pediatric Dentistry Oral Hygiene

Outcome Measures

Primary Outcomes (1)

• streptococcus mutans count

  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

  Baseline (T0), immediately after intervention (T1), and after 4 weeks (T2).

Study Arms (3)

Arm 1: → Coconut Oil Pulling with Clove Oil

EXPERIMENTAL

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.

Behavioral: coconut oil pulling with clove oil

Arm 2: → Coconut Oil Pulling

EXPERIMENTAL

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.

Behavioral: coconut oil pulling

Arm 3: → Fluoride Mouthwash

ACTIVE COMPARATOR

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.

Drug: Fluoride Mouthwash

Interventions

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.

Arm 1: → Coconut Oil Pulling with Clove Oil

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.

Arm 2: → Coconut Oil Pulling

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.

Arm 3: → Fluoride Mouthwash

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patients who have recently received fluoride treatments (within the last 2 weeks).
• Patients with a history of recent antibiotic administration (within the last 2 weeks).
• Patients who have recently used antimicrobial mouth rinses in the last 12 hours or topical fluoride treatments.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Dentistry-Cairo university

Cairo, Cairo Governorate, 12613, Egypt

Location

Faculty of Dentistry Cairo university

Egypt, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Clove Oil

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• nada wassef main supervisor, associate professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

kholoud shaaban principle investigator, BDS

CONTACT

0201007548590; kholoud.shaaban@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will implement triple blinding, where the participants, investigator, and outcome assessors will be unaware of group allocations to reduce bias in results.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)