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

NCT05258955 | Completed Phase 1 DMC

• 1 other identifier: 1030419MAOM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque

Keywords

Dental plaque, Honey, Chlorhexidine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Chlorhexidine

ACTIVE COMPARATOR

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

Drug: Chlorhexidine mouthwash

Natural honey

EXPERIMENTAL

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

Interventions

Natural honey OTHER

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

Also known as: Sidr Honey

Natural honey

Chlorhexidine mouthwash 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

Also known as: Chlorhexidine Gluconate

Chlorhexidine

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individual aged between 18-25
• Retained 28 number of teeth excluding wisdom teeth

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead
• Liaquat College of Medicine and Dentistry: collaborator

Study Sites (1)

Liaquat College of Medicine and Dentistry

Karachi, Sindh, 75800, Pakistan

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

chlorhexidine gluconate

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Muhammad Abid, BDS

  Registrar, Periodontology Liaquat College of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar at LCMD

Model Details: 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

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: June 3, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 21, 2021
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

PA (1)