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NCT Number: NCT07119840

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

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.

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Key information

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Listerine Mouthwash Product

Drug

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

Chlorhexidine mouthwash

Drug

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

Primary outcomes

  1. Gingival Index (GI)

    Time frame: baseline, 2 weeks, and 4 weeks , 8 week

    Measured using standard GI scale (Grades 0-3)

  2. Plaque Index (PI)

    Time frame: baseline, 2 weeks, and 4 weeks , 8 week

    Measured using Orthodontic Plaque Index (Grades 0-4)

Secondary outcomes

  1. Side effects

    Time frame: Baseline till 8 weeks

    The side effects of the trial will be noted in the adverse event log frame.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Naveed Sadiq, PhD

CONTACT

[email protected]

+92 334 9777904

Fazli Rabi, MPH*

CONTACT

[email protected]

+92 307 5663219

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Saidu College of Dentistry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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