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Title: Comparison of Anti-plaque Efficacy of Natural Honey With Chlorhexidine Mouthwash: A Randomized Controlled Trial

NCT ID: NCT05258955

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-03

Study Completion Date

2021-01-21

Brief Summary

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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

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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

Conditions

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Dental Plaque

Keywords

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Dental plaque, Honey, Chlorhexidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Chlorhexidine

these are the group which received chlorhexidine based preparation for plaque reduction

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type DRUG

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

Natural honey

these group will received the honey base mouthwash and the its effect on plaque reduction will be observed in follow up visits

Group Type EXPERIMENTAL

Natural honey

Intervention Type OTHER

Natural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index

Interventions

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Natural honey

Natural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index

Intervention Type OTHER

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

Intervention Type DRUG

Other Intervention Names

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Sidr Honey Chlorhexidine Gluconate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Liaquat College of Medicine and Dentistry

OTHER

Sponsor Role collaborator

Liaquat National Hospital & Medical College

OTHER

Sponsor Role lead

Responsible Party

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Muhammd Abid

Registrar at LCMD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muhammad Abid, BDS

Role: PRINCIPAL_INVESTIGATOR

Registrar, Periodontology Liaquat College of Medicine and Dentistry

Locations

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Liaquat College of Medicine and Dentistry

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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1030419MAOM

Identifier Type: -

Identifier Source: org_study_id