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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05258955
Other study ID # 1030419MAOM
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 3, 2020
Est. completion date January 21, 2021

Study information

Verified date February 2022
Source Liaquat National Hospital & Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The rationale of our study is to compare the efficacy of natural honey base preparation with other commercially available mouthwashes i.e chlorhexidine base in prevention of dental plaque formation as honey is readily available and cost effective and organic in nature. This study will help to provide the data of our community and positive result may provide a new method of oral hygiene maintenance with fewer side effects. We will be able to deliver the best anti-plaque agent.


Description:

In this study, participants will assigned into 2 group those who will fulfilled the inclusion and exclusion criteria. After the informed consent, they were divided into 2 group. Group A will received Chlorhexidine mouthwash and Group B will provided with honey based mouthwash. The participant will blinded as solution will be provided in dark color bottle to mask the study. After which the baseline plaque index will be taken followed by recording plaque index on 7th, 14th, and 21st day. The statistical analysis will be done to compare the mean difference between these 2 groups


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 21, 2021
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: 1. Individual aged between 18-25 2. Retained 28 number of teeth excluding wisdom teeth Exclusion Criteria: 1. Individual with medical illness affecting oral cavity like diabetes, sjögren syndrome, crohn disease etc 2. Multiple extraction , overhang restoration, wearing any appliance 3. Periodontal problem with pocket depth more than 3mm 4. Current or recent history of antibiotic consumption 5. Noncompliance that is unable to maintain their hygiene. 6. Pan, Betel quid and any other oral habit will not be included in study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Natural honey
Natural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index
Drug:
Chlorhexidine mouthwash
Chlorhexidine gluconate 0.12% mouthwash is used as intervention in Group A (Arm Group A) for the comparison of plaque reduction among group A and B

Locations

Country Name City State
Pakistan Liaquat College of Medicine and Dentistry Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Liaquat National Hospital & Medical College Liaquat College of Medicine and Dentostry

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dental Plaque primary outcome is to assessed the reduction on plaque level among Group A and Group B reduction of plaque index will be assessed on 7th day, 14th day and on 21st day
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