Evaluation of Bleeding on Brushing Using Neem Extract Mouthwash Versus Chlorhexidine Mouthwash (mouthwash)
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|ClinicalTrials.gov Identifier: NCT03166163|
Recruitment Status : Unknown
Verified May 2017 by Samar Sherif Ali Mostafa, Cairo University.
Recruitment status was: Enrolling by invitation
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gingival Bleeding||Drug: Azadirachta indica Drug: Chlorhexidine mouthwash||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||This was a double -blind study as the investigator was unaware about the sampling of the groups and study subjects were unaware about the mouthwash they were using|
|Official Title:||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|
|Actual Study Start Date :||May 20, 2017|
|Estimated Primary Completion Date :||June 11, 2017|
|Estimated Study Completion Date :||June 11, 2017|
Experimental: Azadirachta indica (Neem extract)
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
Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks
Other Name: neem extract
Active Comparator: 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
Drug: Chlorhexidine mouthwash
its an antimocrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily (10 ml each) for 3 weeks
Other Name: chlohexidine
- Bleeding on brushing [ Time Frame: 3 weeks ]measuring device(asking the patient) measuring unit (binary)
- sulcus bleeding index [ Time Frame: 3 weeks ]measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166163
|Samar Sherif Ali Moustafa|
|Study Director:||Sherif B Eltaweel, Ass. prof||Cairo University|