Evaluation of Bleeding on Brushing Using Neem Extract Mouthwash Versus Chlorhexidine Mouthwash

Study Overview
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Brief Summary
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i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of Egyptian children.

Detailed Description
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First , we will select the patients according to the inclusion criteria. We will take sulcus bleeding index which is defined as an index of gingival inflammation in which bleeding is measured from four gingival units using a periodontal probe. The scoring is ranging around eight anterior teeth from 0 to 5.In this study, we will take only score 2 which is bleeding on probing, change in colour and no edema in order to reduce variability. 2%neem extract will be used to prepare mouthwash while, chlorhexidine will be used as positive control. Chlorhexidine will be coded with the letter A and the mouthwash of 2%neem extract with the letter B. The participants included will be allocated into 2 groups by drawing of sealed and opaque envelopes containing the codes A and B The intra and extraoral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and WHO probe. All materials will be packaged in sterilization wraps and autoclaved, following the required biosafety standards. The rinses will be performed twice daily, which will be supervised by the parents legal guardians previously instructed. Kits containing toothpaste an brush will be provided, so that the patients will use the same toothpaste, avoiding any interference with the results. After 3 weeks, we will ask the patient if there is any gingival bleeding in addition we will measure the sulcus bleeding index.

Official Title
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Evaluation of Bleeding on Brushing Among a Group of Egyptian Children After Using Azadirachta Indica (Neem Extract)Mouthwash Versus Chlorhexidine Mouthwash: A Randomized Controlled Trial

Conditions
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Gingival Bleeding

Intervention / Treatment
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* Drug: Azadirachta indica
* Drug: Chlorhexidine mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Children aged 8-10 years old with gingivitis 2. cooperative children 3.both genders 4.medically free 5. sulcus bleeding index score is 2 Exclusion Criteria: 1. Children undergoing orthodontic treatment 2.Children undergoing any other oral hygiene aid other than routine teeth brushing 3.Children with known history of allergy to any mouthwash or drug 4.Parents unable to give informed consent 5.Children taking antibiotic or antiseptic in previous two months

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azadirachta indica (Neem extract)<br>its herbal mouthwash that will be given to a group a Egyptian children twice a day(10 ml each) for 3 weeks | Drug: Azadirachta indica<br>* Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks<br>* Other names: neem extract;|
| Active Comparator: chlorhexidine mouthwash<br>its an antimoicrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily(10 ml each) for 3 weeks | Drug: Chlorhexidine mouthwash<br>* its an antimocrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily (10 ml each) for 3 weeks<br>* Other names: chlohexidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on brushing | measuring device(asking the patient) measuring unit (binary) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sulcus bleeding index | measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index) | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleeding on brushing