Comparison Of Clinical Effects Of Listerine And Chlorhexidine Mouth Wash In Patients Undergoing Fixed Orthodontic Treatment

November 20, 2025 updated by: Khyber Medical University Peshawar
This randomized clinical trial aims to compare the effectiveness of Listerine and Chlorhexidine mouthwashes in improving periodontal health in patients undergoing fixed orthodontic treatment. Gingival Index and Plaque Index will be assessed at baseline, 2 weeks, and 4 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Orthodontic treatment using fixed appliances can significantly impair oral hygiene due to the presence of brackets, bands, and wires, which create retentive areas that promote plaque accumulation. This buildup can result in gingival inflammation, leading to gingivitis or even periodontitis if not managed effectively. Mechanical plaque control, such as brushing and flossing, is often insufficient under these conditions. Thus, adjunctive chemical plaque control agents like mouthwashes are commonly recommended.

Chlorhexidine (CHX) is widely considered the gold standard for chemical plaque control due to its broad-spectrum antimicrobial activity and prolonged substantivity in the oral cavity. However, CHX is associated with side effects such as tooth staining, altered taste sensation, and mucosal irritation, limiting its long-term use. In contrast, Listerine is a commercially available essential oil-based mouthwash that has demonstrated anti-plaque and anti-inflammatory properties without the same level of side effects.

This double-blind, randomized controlled trial aims to compare the clinical efficacy of CHX (0.12%) and Listerine mouthwash in improving periodontal health among patients undergoing fixed orthodontic treatment. The study will be conducted over a period of 4 weeks at the Orthodontics Department of Saidu College of Dentistry, Swat. A total of 60 participants (30 per group), aged between 13 and 25 years, will be enrolled using non-probability consecutive sampling. Participants will be randomized into two groups using block randomization: one receiving CHX and the other Listerine, both in identical, unlabelled bottles to ensure blinding of both the investigator and participants.

The primary outcome measures are changes in Plaque Index (PI) and Gingival Index (GI), assessed at baseline (Day 0), 2 weeks, and 4 weeks. Oral examinations will be conducted by calibrated examiners using standard indices and WHO probes. Data will be analyzed using R software, with t-tests applied to compare mean scores between groups. Age and gender will be considered as potential effect modifiers.

The study is designed to evaluate whether Listerine, as a more tolerable alternative, provides comparable or superior improvements in periodontal health compared to CHX in orthodontic patients. If proven effective, Listerine may serve as a safer, more acceptable option for long-term use during orthodontic treatment.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dr Naveed Sadiq, PhD
  • Phone Number: +92 334 9777904
  • Email: sadiq@kmu.edu.pk

Study Locations

  • Pakistan
    • KPK
      • Swāt, KPK, Pakistan
        • Recruiting
        • Saidu College of Dentistry
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged 13-40 years
  • Permanent dentition (including first molars)
  • Willing to undergo orthodontic treatment and follow instructions

Exclusion Criteria:

  • Systemic illness (e.g., diabetes, heart disease, hepatitis)
  • Pregnant/lactating females
  • Tobacco use
  • History of allergies to mouthwash/toothpaste
  • Use of mouthwash in past 3 months
  • Abnormal oral morphology or parafunctional habits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Listerine Group
Participants will receive Listerine mouthwash in unlabelled bottles once daily for 4 weeks.
Drug: Listerine Mouthwash Product
Participants in this group will receive Listerine mouthwash containing essential oils (menthol, thymol, eucalyptol, and methyl salicylate). They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given.
Other Names:
  • Essential Oil Mouthwash
Active Comparator: Chlorhexidine Group
Participants will receive chlorhexidine mouthwash in unlabelled bottles once daily for 4 weeks.
Drug: Chlorhexidine mouthwash
Participants in this group will receive Chlorhexidine mouthwash at a concentration of 0.12%. They will be instructed to rinse once daily with 10 ml of the solution for 30 seconds after brushing, over a period of 4 weeks. The mouthwash will be dispensed in unlabelled bottles to maintain blinding. Standard oral hygiene instructions will be given.
Other Names:
  • CHX Mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival Index (GI)
Time Frame: baseline, 2 weeks, and 4 weeks , 8 week
Measured using standard GI scale (Grades 0-3)
baseline, 2 weeks, and 4 weeks , 8 week
Plaque Index (PI)
Time Frame: baseline, 2 weeks, and 4 weeks , 8 week
Measured using Orthodontic Plaque Index (Grades 0-4)
baseline, 2 weeks, and 4 weeks , 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: Baseline till 8 weeks
The side effects of the trial will be noted in the adverse event log frame.
Baseline till 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Medical University Peshawar

Collaborators

Saidu College of Dentistry

Investigators

  • Principal Investigator: Fazli Rabi, MPH*, Khyber Medical University
  • Principal Investigator: Dr Naveed Sadiq, PhD, Khyber Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

November 29, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 6, 2025

First Submitted That Met QC Criteria

August 6, 2025

First Posted (Actual)

August 13, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU/DIR/CTU/2025/005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Non Applicable

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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