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

Primary Purpose

Gingival Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Azadirachta indica
Chlorhexidine mouthwash
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Bleeding focused on measuring bleeding on brushing

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Samar Sherif Ali Moustafa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azadirachta indica (Neem extract)

chlorhexidine mouthwash

Arm Description

its herbal mouthwash that will be given to a group a Egyptian children twice a day(10 ml each) for 3 weeks

its an antimoicrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily(10 ml each) for 3 weeks

Outcomes

Primary Outcome Measures

Bleeding on brushing
measuring device(asking the patient) measuring unit (binary)

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2017
Last Updated
May 24, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03166163
Brief Title
Evaluation of Bleeding on Brushing Using Neem Extract Mouthwash Versus Chlorhexidine Mouthwash
Acronym
mouthwash
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
June 11, 2017 (Anticipated)
Study Completion Date
June 11, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Bleeding
Keywords
bleeding on brushing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Azadirachta indica (Neem extract)
Arm Type
Experimental
Arm Description
its herbal mouthwash that will be given to a group a Egyptian children twice a day(10 ml each) for 3 weeks
Arm Title
chlorhexidine mouthwash
Arm Type
Active Comparator
Arm Description
its an antimoicrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily(10 ml each) for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Azadirachta indica
Other Intervention Name(s)
neem extract
Intervention Description
Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
chlohexidine
Intervention Description
its an antimocrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily (10 ml each) for 3 weeks
Primary Outcome Measure Information:
Title
Bleeding on brushing
Description
measuring device(asking the patient) measuring unit (binary)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
sulcus bleeding index
Description
measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif B Eltaweel, Ass. prof
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Samar Sherif Ali Moustafa
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
it will be available when it is finished
Citations:
PubMed Identifier
23852229
Citation
Balappanavar AY, Sardana V, Singh M. Comparison of the effectiveness of 0.5% tea, 2% neem and 0.2% chlorhexidine mouthwashes on oral health: a randomized control trial. Indian J Dent Res. 2013 Jan-Feb;24(1):26-34. doi: 10.4103/0970-9290.114933.
Results Reference
background
PubMed Identifier
26876277
Citation
Dhingra K, Vandana KL. Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review. Int J Dent Hyg. 2017 Feb;15(1):4-15. doi: 10.1111/idh.12191. Epub 2016 Feb 15.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Comparison+of+the+effectiveness+of+0.5%25+tea%2C+2%25+neem+and+0.2%25+chlorhexidine+mouthwashes+on+oral+health%3A+a+randomized+control+trial.
Description
Comparison of the effectiveness of 0.5% tea, 2% neem and 0.2% chlorhexidine mouthwashes on oral health: a randomized control trial.
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Effectiveness+of+Azadirachta+Indica+(neem)+mouthrinse+in+plaque+and+gingivitis+control%3Aa+systematic+review
Description
Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review.

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

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