Back to resultsTitle: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Natural honey
Chlorhexidine mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque focused on measuring Dental plaque, Honey, Chlorhexidine
Eligibility Criteria
Inclusion Criteria:
- Individual aged between 18-25
- Retained 28 number of teeth excluding wisdom teeth
Exclusion Criteria:
- Individual with medical illness affecting oral cavity like diabetes, sjögren syndrome, crohn disease etc
- Multiple extraction , overhang restoration, wearing any appliance
- Periodontal problem with pocket depth more than 3mm
- Current or recent history of antibiotic consumption
- Noncompliance that is unable to maintain their hygiene.
- Pan, Betel quid and any other oral habit will not be included in study
Sites / Locations
- Liaquat College of Medicine and Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Chlorhexidine
Natural honey
Arm Description
these are the group which received chlorhexidine based preparation for plaque reduction
these group will received the honey base mouthwash and the its effect on plaque reduction will be observed in follow up visits
Outcomes
Primary Outcome Measures
Dental Plaque
primary outcome is to assessed the reduction on plaque level among Group A and Group B
Secondary Outcome Measures
Full Information
NCT ID
NCT05258955
First Posted
February 17, 2022
Last Updated
February 17, 2022
Sponsor
Liaquat National Hospital & Medical College
Collaborators
Liaquat College of Medicine and Dentostry
1. Study Identification
Unique Protocol Identification Number
NCT05258955
Brief Title
Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
Official Title
Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
January 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liaquat National Hospital & Medical College
Collaborators
Liaquat College of Medicine and Dentostry
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
Dental plaque, Honey, Chlorhexidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The participants divided into two groups. one group will received honey based oral rinses and other group received chlorhexidine mouthwash and will evaluate the reduction of dental plaque
Masking
Participant
Masking Description
The mouthwash were distributed in dark color coded bottle and marked with label A and B, as to maintain masking among the the participants of the study.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chlorhexidine
Arm Type
Active Comparator
Arm Description
these are the group which received chlorhexidine based preparation for plaque reduction
Arm Title
Natural honey
Arm Type
Experimental
Arm Description
these group will received the honey base mouthwash and the its effect on plaque reduction will be observed in follow up visits
Intervention Type
Other
Intervention Name(s)
Natural honey
Other Intervention Name(s)
Sidr Honey
Intervention Description
Natural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
Chlorhexidine Gluconate
Intervention Description
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
Primary Outcome Measure Information:
Title
Dental Plaque
Description
primary outcome is to assessed the reduction on plaque level among Group A and Group B
Time Frame
reduction of plaque index will be assessed on 7th day, 14th day and on 21st day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Individual aged between 18-25
Retained 28 number of teeth excluding wisdom teeth
Exclusion Criteria:
Individual with medical illness affecting oral cavity like diabetes, sjögren syndrome, crohn disease etc
Multiple extraction , overhang restoration, wearing any appliance
Periodontal problem with pocket depth more than 3mm
Current or recent history of antibiotic consumption
Noncompliance that is unable to maintain their hygiene.
Pan, Betel quid and any other oral habit will not be included in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Abid, BDS
Organizational Affiliation
Registrar, Periodontology Liaquat College of Medicine and Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liaquat College of Medicine and Dentistry
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75800
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial
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