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UnknownNCT03166163

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
86 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
8 Years – 10 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DRUGAzadirachta indicaIts a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks
DRUGChlorhexidine mouthwashits an antimocrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily (10 ml each) for 3 weeks

Timeline

Start date
2017-05-20
Primary completion
2017-06-11
Completion
2017-06-11
First posted
2017-05-25
Last updated
2017-05-25

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT03166163. Inclusion in this directory is not an endorsement.