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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.
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.
Age
13 - 40 years
Sex
ALL
Healthy Volunteers
Yes
Saidu College of Dentistry
Swāt, KPK, Pakistan
Start Date
August 1, 2025
Primary Completion Date
November 29, 2025
Completion Date
December 30, 2025
Last Updated
November 26, 2025
60
ESTIMATED participants
Listerine Mouthwash Product
DRUG
Chlorhexidine mouthwash
DRUG
Lead Sponsor
Khyber Medical University Peshawar
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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