Dental CariesCOPCONCT06902532
Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children
A study testing coconut oil pulling with clove oil, coconut oil pulling and Fluoride Mouthwash in people with Dental Caries, run by Cairo University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- coconut oil pulling with clove oil, coconut oil pulling and Fluoride Mouthwash
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2025to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of Dentistry-Cairo university
Cairo, Cairo Governorate, 12613
kholoud shaaban principle investigator, BDS, 021007548590
Faculty of Dentistry Cairo university
Egypt, Cairo Governorate, 12613
kholoud shaaban principle investigator, BDS, 0201007548590, kholoud.shaaban@dentistry.cu.edu.eg
kholoud shaaban principle investigator, BDS
About this study
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:
- Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil.
- Coconut Oil Pulling Group - Daily swishing with coconut oil alone.
- Fluoride Mouthwash Group (Control) - Using fluoride mouthwash as per standard guidelines.
Read more
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.
Read the 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
- Being tested
- coconut oil pulling with clove oil, coconut oil pulling, Fluoride Mouthwash
- Keywords
- Tooth Decay Streptococcus Mutans Oil Pulling Coconut Oil Clove Oil Fluoride Mouthwash Pediatric Dentistry Oral Hygiene
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coconut oil pulling with clove oilBehavioural
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 pullingBehavioural
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 MouthwashDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Fluoride Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (T0), immediately after intervention (T1), and after 4 weeks (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholoud shaaban abdelmonaem mohamed, Cairo University
- Investigators
- nada wassef main supervisor, associate professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902532
- Sponsor's protocol ID
- COPCO-2025
- Other IDs
- self funded study
- Acronym
- COPCO
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to institutional and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children
- ClinicalTrials.gov ID
- NCT06902532
- Acronym / sponsor ID
- COPCO / COPCO-2025
- Conditions
- Dental Caries
- Keywords
- Tooth Decay Streptococcus Mutans Oil Pulling Coconut Oil Clove Oil Fluoride Mouthwash Pediatric Dentistry Oral Hygiene
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil.
- Coconut Oil Pulling Group - Daily swishing with coconut oil alone.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: → Coconut Oil Pulling with Clove Oil | Experimental | Behavioral: coconut oil pulling with clove oilArm 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. |
| Arm 2: → Coconut Oil Pulling | Experimental | Behavioral: coconut oil pullingArm 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. |
| Arm 3: → Fluoride Mouthwash | Active comparator | Drug: Fluoride MouthwashArm 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coconut oil pulling with clove oilParticipants 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. | Behavioural | Arm 1: → Coconut Oil Pulling with Clove Oil |
| coconut oil pullingParticipants 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. | Behavioural | Arm 2: → Coconut Oil Pulling |
| Fluoride MouthwashParticipants 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. | Drug | Arm 3: → Fluoride Mouthwash |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to institutional and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
nada wassef main supervisor, associate professor study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coconut oil pulling with clove oil, coconut oil pulling and Fluoride Mouthwash in people with Dental Caries, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kholoud shaaban principle investigator, BDS (0201007548590, kholoud.shaaban@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
streptococcus mutans count (time frame: Baseline (T0), immediately after intervention (T1), and after 4 weeks (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.