Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

Study Overview
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Brief Summary
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The mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients that prevent and control both supragingival biofilm and gingivitis, specially when used adjunctively to mechanical oral hygiene regimens.

Detailed Description
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In vitro and clinical researches using Punica granatum Linn shows antimicrobial and antiadherent activity against dental biofilm microorganisms. The purpose of this study was to evaluate the clinical effectiveness of a mouthwash of Punica granatum Linn. against biofilm and gingival inflammation in school children

Official Title
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Clinical Effectiveness and Microbiological Evaluation of a Mouthwash of Pomegranate (Punica Granatum Linn.) in School Children

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Punica granatum Linn.
* Drug: chlorhexidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group: 09-12 years old Presence of at least 20 teeth Simplified Oral Hygiene Index (S-OHI)≥ 1,6 Exclusion Criteria: Use of orthodontic appliance Recent (in the past 2 months)use of antibiotics and mouthwashes

Ages Eligible for Study
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Minimum Age: 9 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 |
| --- | --- |
| Experimental: Punica granatum Linn.<br>The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days. | Drug: Punica granatum Linn.<br>* Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days<br>* Other names: Pomegranate;|
| Active Comparator: chlorhexidine<br>The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days. | Drug: chlorhexidine<br>* standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days<br>* Other names: Periogard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the Gingival Index scores. | On day 0, we measured the Plaque Index (PI) (Silness; Löe, 1964) at baseline, on the seventh day and on the fourteenth day. | Baseline, Seventh Day and Fourteeth day (14 days) | 
| Difference in the Gingival Bleeding Index scores. | On day 0, we measured the Bleeding on Probing Index (BPI) (Ainamo; Bay, 1975) at baseline, on the seventh day and on the fourteenth day. | Baseline, Seventh Day andFourteeth day (14 days) | 
| Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study. | At baseline, we collected non-stimulated saliva samples into a sterile container for counting of oral streptococci in the laboratory. And on the fourteenth day, we carried out the second saliva collection and measured the clinical indices used. | Baseline and Fourteeth day (14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DENTAL PLAQUE, MEDICINAL PLANTS, GINGIVITIS