Clinical trial NCT03166163: Evaluation of Bleeding on Brushing Using Neem Extract Mouthwash Versus Chlorhexidine 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Bleeding
Keywords: bleeding on brushing
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 86
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

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

Primary outcomes:
measure: Bleeding on brushing
timeFrame: 3 weeks
Secondary outcomes:
measure: sulcus bleeding index
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Samar Sherif Ali Moustafa
Study officials:
affiliation: Cairo University
name: Sherif B Eltaweel, Ass. prof
role: STUDY_DIRECTOR
References:
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.
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.