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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-20

Study Completion Date

2017-06-11

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gingival Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

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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

Group Type EXPERIMENTAL

Azadirachta indica

Intervention Type DRUG

Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks

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

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type DRUG

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

Interventions

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Azadirachta indica

Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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neem extract chlohexidine

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes