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| ID | Type | Description | Link |
|---|---|---|---|
| self funded study | Other Identifier | Cairo university-faculty of dentistry |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| kholoud shaaban principle investigator, BDS | Contact | 0201007548590 | kholoud.shaaban@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| nada wassef main supervisor, associate professor | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry-Cairo university | Cairo | Cairo Governorate | 12613 | Egypt |
Individual participant data (IPD) will not be shared due to institutional and ethical considerations.
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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.
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This study will implement triple blinding, where the participants, investigator, and outcome assessors will be unaware of group allocations to reduce bias in results.
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| 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. |
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| 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. |
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| Faculty of Dentistry Cairo university | Egypt | Cairo Governorate | 12613 | Egypt |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D045783 | Clove Oil |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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