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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03166163
Acronym
mouthwash
Enrollment
86
Registered
2017-05-25
Start date
2017-05-20
Completion date
2017-06-11
Last updated
2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Bleeding

Keywords

bleeding on brushing

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.

Interventions

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

DRUGChlorhexidine mouthwash

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bleeding on brushing3 weeksmeasuring device(asking the patient) measuring unit (binary)

Secondary

MeasureTime frameDescription
sulcus bleeding index3 weeksmeasuring device (measuring the sulcus bleeding index) measuring unit (the score of the sulcus bleeding index)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026