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Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03166163
Study type Interventional
Source Cairo University
Contact
Status Enrolling by invitation
Phase N/A
Start date May 20, 2017
Completion date June 11, 2017

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