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

NCT03166163 | Unknown DMC

• 1 other identifier: 2621985
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Bleeding

Keywords

bleeding on brushing

Outcome Measures

Primary Outcomes (1)

• Bleeding on brushing

  measuring device(asking the patient) measuring unit (binary)

  3 weeks

Secondary Outcomes (1)

• sulcus bleeding index

  3 weeks

Study Arms (2)

Azadirachta indica (Neem extract)

EXPERIMENTAL

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

Drug: Azadirachta indica

chlorhexidine mouthwash

ACTIVE COMPARATOR

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

Drug: Chlorhexidine mouthwash

Interventions

Azadirachta indica DRUG

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

Also known as: neem extract

Azadirachta indica (Neem extract)

Chlorhexidine mouthwash DRUG

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

Also known as: chlohexidine

chlorhexidine mouthwash

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \. Children aged 8-10 years old with gingivitis
• \. cooperative children
• both genders
• medically free
• \. sulcus bleeding index score is 2

You may not qualify if:

• \. Children undergoing orthodontic treatment
• Children undergoing any other oral hygiene aid other than routine teeth brushing
• Children with known history of allergy to any mouthwash or drug
• Parents unable to give informed consent
• Children taking antibiotic or antiseptic in previous two months

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Samar Sherif Ali Moustafa

Cairo, Egypt

Location

Related 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.

  PMID: 23852229 BACKGROUND

• 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.

  PMID: 26876277 BACKGROUND

Related 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.

MeSH Terms

Conditions

Gingival Hemorrhage

Interventions

neem oil

Condition Hierarchy (Ancestors)

Oral Hemorrhage; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sherif B Eltaweel, Ass. prof

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master dental student, pediatric dentistry department.

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 25, 2017
• Study Start: May 20, 2017
• Primary Completion: June 11, 2017
• Study Completion: June 11, 2017
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)