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
| Registry | NCT03166163, acronym mouthwash |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 86 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Gingival Bleeding |
| Interventions | Azadirachta indica, Chlorhexidine mouthwash (Drug) |
| Dates | start 2017-05-20, primary completion 2017-06-11 (estimated), completion 2017-06-11 (estimated), first posted 2017-05-25, last updated 2017-05-25 |
| Locations | 1 site in Egypt |
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All trials for Gingival Bleeding All trials of Azadirachta indica All trials of Chlorhexidine mouthwash
i will compare the effect of neem extract mouthwash versus the chlorhexidine mouthwash on bleeding on brushing among a group of Egyptian children.
1. First , we will select the patients according to the inclusion criteria.
2. 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.
3. 2%neem extract will be used to prepare mouthwash while, chlorhexidine will be used as positive control.
4. Chlorhexidine will be coded with the letter "A" and the mouthwash of 2%neem extract with the letter "B".
5. The participants included will be allocated into 2 groups by drawing of sealed and opaque envelopes containing the codes "A" and "B"
6. 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.
7. 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.
8. After 3 weeks, we will ask the patient if there is any gingival bleeding in addition we will measure the sulcus bleeding index.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Azadirachta indica (Neem extract) | Experimental | Drug: Azadirachta indica | its herbal mouthwash that will be given to a group a Egyptian children twice a day(10 ml each) for 3 weeks |
| chlorhexidine mouthwash | Active comparator | Drug: Chlorhexidine mouthwash | its an antimoicrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily(10 ml each) for 3 weeks |
Sex: All, ages: 8 Years to 10 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Samar Sherif Ali Moustafa | Cairo | Egypt |