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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Plaque
• Intervention / Treatment: Drug: Chlorhexidine mouthwash; Other: Natural honey

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75800
      • Liaquat College of Medicine and Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Chlorhexidine; these are the group which received chlorhexidine based preparation for plaque reduction	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; Other Names: Chlorhexidine Gluconate
EXPERIMENTAL: Natural honey; these group will received the honey base mouthwash and the its effect on plaque reduction will be observed in follow up visits	Other: Natural honey; Natural Sidr honey based mouthwash used as intervention group B (Arm Group B) for the reduction of plaque index; Other Names: Sidr Honey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Liaquat National Hospital & Medical College
• Collaborators: Liaquat College of Medicine and Dentostry
• Investigators: Principal Investigator: Muhammad Abid, BDS, Registrar, Periodontology Liaquat College of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2020
• Primary Completion (ACTUAL): December 30, 2020
• Study Completion (ACTUAL): January 21, 2021

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): February 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Dental plaque, Honey, Chlorhexidine
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 1030419MAOM

Drug and device information, study documents

• 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