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Evaluation of Bleeding on Brushing Using Neem Extract Mouthwash Versus Chlorhexidine Mouthwash (mouthwash)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Samar Sherif Ali Mostafa, Cairo University

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

Condition or disease Intervention/treatment Phase
Gingival Bleeding Drug: Azadirachta indica Drug: Chlorhexidine mouthwash Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bleeding on brushing [ Time Frame: 3 weeks ]
    measuring device(asking the patient) measuring unit (binary)

Secondary Outcome Measures :
  1. sulcus bleeding index [ Time Frame: 3 weeks ]
    measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03166163

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Samar Sherif Ali Moustafa
Cairo, Egypt
Sponsors and Collaborators
Cairo University
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Study Director: Sherif B Eltaweel, Ass. prof Cairo University

Additional Information:
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Responsible Party: Samar Sherif Ali Mostafa, Master dental student, pediatric dentistry department., Cairo University Identifier: NCT03166163     History of Changes
Other Study ID Numbers: 2621985
2621985 ( Other Identifier: CairoU )
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: it will be available when it is finished

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samar Sherif Ali Mostafa, Cairo University:
bleeding on brushing

Additional relevant MeSH terms:
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Gingival Hemorrhage
Oral Hemorrhage
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents