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

Gingival Bleeding Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03166163
• Other study ID #: 2621985
• Secondary ID: 2621985
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 23, 2017
• Last updated: May 24, 2017
• Start date: May 20, 2017
• Est. completion date: June 11, 2017

Study information

• Verified date: May 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 86
• Est. completion date: June 11, 2017
• Est. primary completion date: June 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Bleeding
• Gingival Hemorrhage
• Hemorrhage

Intervention

Drug:
• Azadirachta indica
Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks
• 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

Locations

Country	Name	City	State
Egypt	Samar Sherif Ali Moustafa	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding on brushing	measuring device(asking the patient) measuring unit (binary)	3 weeks
Secondary	sulcus bleeding index	measuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)	3 weeks

External Links

•   Comparison of the effectiveness of 0.5% tea, 2% neem and 0.2% chlorhexidine mouthwashes on oral health: a randomized control trial.
•   Effectiveness of Azadirachta indica (neem) mouthrinse in plaque and gingivitis control: a systematic review.