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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03166163
Collaborator
(none)
86
Enrollment
1
Location
2
Arms
22
Anticipated Duration (Days)
119
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Azadirachta indica
  • Drug: Chlorhexidine mouthwash
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Jun 11, 2017
Anticipated Study Completion Date :
Jun 11, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • chlohexidine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bleeding on brushing [3 weeks]

      measuring device(asking the patient) measuring unit (binary)

    Secondary Outcome Measures

    1. sulcus bleeding index [3 weeks]

      measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. Children aged 8-10 years old with gingivitis
    1. cooperative children

    3.both genders

    4.medically free

    1. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samar Sherif Ali Moustafa Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Sherif B Eltaweel, Ass. prof, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Samar Sherif Ali Mostafa, Master dental student, pediatric dentistry department., Cairo University
    ClinicalTrials.gov Identifier:
    NCT03166163
    Other Study ID Numbers:
    • 2621985
    • 2621985
    First Posted:
    May 25, 2017
    Last Update Posted:
    May 25, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Master dental student, pediatric dentistry department., Cairo University
    bleeding on brushing
    Additional relevant MeSH terms:
    Gingival Hemorrhage
    Hemorrhage
    Chlorhexidine

    Study Results

    No Results Posted as of May 25, 2017