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

May 24, 2017 updated by: Samar Sherif Ali Mostafa, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Samar Sherif Ali Moustafa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on brushing
Time Frame: 3 weeks
measuring device(asking the patient) measuring unit (binary)
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sulcus bleeding index
Time Frame: 3 weeks
measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2017

Primary Completion (Anticipated)

June 11, 2017

Study Completion (Anticipated)

June 11, 2017

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2621985 (Other Identifier: CairoU)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

it will be available when it is finished

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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