Effects of Three Different Mouth Rinses on Dental Plaque in Children

Study Overview
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Brief Summary
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Dental plaque is a major problem in the field of oral and dental health and its prevention is more important to avoid dental caries and gingival diseases. Mouth washes are very useful in the reduction of microbial plaque and gingival inflammation. Sodium fluoride mouth wash is one of the ways that prevent dental plaque. Recently, using herbal products are efficient in decreasing dental plaque. Pomegranate peels and Guava leaves extracts are an essential medicinal plant with various pharmacological properties. Aim of study: To evaluate and compare the efficiency of different mouth rinses (sodium fluoride mouth rinse, guava leaves aqueous extract and pomegranate aqueous extract) on dental plaque in children, clinically by measuring gingival and plaque indices scores and microbiologically by measuring of streptococcus mutans and lactobacillus. Materials and methods: forty apparently healthy and cooperative children were selected from the Outpatient Dental Clinic of Pediatric dentistry Department, Faculty of Dentistry, Suez Canal University. Children were randomly divided into three groups as follows: Group (I):10 children will rinse with sodium fluoride, Group (II): 10 children will rinse with guava leaves aqueous extract and Group (III):10 children will rinse with pomegranate peels aqueous extract. Group (IV):10 children will rinse with water (control group). Instructions for oral hygiene and using mouth wash will be demonstrated for every child. Clinical and microbiological examinations will be done firstly at day one before using any type of examined mouthwashes (0-base line), then clinical and microbiological follow up will be done after 7 and 15 days of using different mouthwash for each group.

Official Title
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Clinical and Microbiological Effects of Three Different Mouth Rinses Made of Sodium Fluoride, Guava Leaves Extract or Pomegranate Peel Extract on Dental Plaque in Children

Conditions
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Gingival Diseases

Intervention / Treatment
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* Drug: sodium fluoride solution
* Drug: guava leaves aqueous extract
* Drug: pomegranate peel aqueous extrac
* Other: Distilled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children are apparently healthy. Their age's ranges from 6-12 years {mixed dentition}, First permanent molars were fully erupted. Children are not taking antibiotics, steroids and inflammatory therapy for two weeks before study or during this study. Children are caries free at time of the study. Children with no regular use of chewing xylitol gum. Children without orthodontic appliance. Children are not using fluoride tooth paste or any topical fluoride application at time of study. Children who have dental plaque. Exclusion Criteria: Uncooperative children. Children with history of allergy to dental products or their products Parents refusal.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sodium fluoride solution<br>children will rinse with sodium fluoride solution mouth rinse (0.2%). | Drug: sodium fluoride solution<br>* sodium fluoride solution mouth rinse (0.2%).<br>|
| Active Comparator: guava leaves<br>children will rinse with guava leaves aqueous extract mouth rinse (0.5%). | Drug: guava leaves aqueous extract<br>* guava leaves aqueous extract mouth rinse (0.5%)<br>|
| Active Comparator: pomegranate peel<br>children will rinse with pomegranate peel aqueous extract mouth rinse (0.5%). | Drug: pomegranate peel aqueous extrac<br>* pomegranate peel aqueous extract mouth rinse (0.5%).<br>|
| Placebo Comparator: Control<br>children will rinse with distilled water | Other: Distilled water<br>* placebo distilled water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival health | gingival index score from 0 to 3, where 0 normal gingiva and 3 severe inflammation | baseline , after 7 days and after 15 days | 
| plaque accumulation and pocket depth | plaque index score from 0 to 3, where 0 no plaque and 3 abundance of soft matter within gingival pocket | baseline , after 7 days and after 15 days | 
| streptococcus mutans and lactobacilli count | calculate the counts of streptococcus mutans and lactobacilli | baseline , after 7 days and after 15 days |