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

Cairo University (CU)

Status: Unknown

Conditions: Gingival Bleeding

Treatments: Drug: Azadirachta indica; Drug: Chlorhexidine mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT03166163

2621985 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Azadirachta indica (Neem extract)

Experimental group

Description:

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

Treatment:

Drug: Azadirachta indica

chlorhexidine mouthwash

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine mouthwash