Comparison Of Clinical Effects Of Listerine And Chlorhexidine Mouth Wash In Patients Undergoing Fixed Orthodontic Treatment
NCT ID: NCT07119840
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-08-01
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Listerine Group
Participants will receive Listerine mouthwash in unlabelled bottles once daily for 4 weeks.
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.
Chlorhexidine Group
Participants will receive chlorhexidine mouthwash in unlabelled bottles once daily for 4 weeks.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Permanent dentition (including first molars)
* Willing to undergo orthodontic treatment and follow instructions
Exclusion Criteria
* Pregnant/lactating females
* Tobacco use
* History of allergies to mouthwash/toothpaste
* Use of mouthwash in past 3 months
* Abnormal oral morphology or parafunctional habits
13 Years
40 Years
ALL
Yes
Sponsors
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Saidu College of Dentistry
OTHER
Khyber Medical University Peshawar
OTHER
Responsible Party
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Principal Investigators
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Fazli Rabi, MPH*
Role: PRINCIPAL_INVESTIGATOR
Khyber Medical University
Dr Naveed Sadiq, PhD
Role: PRINCIPAL_INVESTIGATOR
Khyber Medical University
Locations
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Saidu College of Dentistry
Swāt, KPK, Pakistan
Countries
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Central Contacts
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Facility Contacts
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References
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Dehghani M, Abtahi M, Hasanzadeh N, Farahzad Z, Noori M, Noori M. Effect of Propolis mouthwash on plaque and gingival indices over fixed orthodontic patients. J Clin Exp Dent. 2019 Mar 1;11(3):e244-e249. doi: 10.4317/jced.55026. eCollection 2019 Mar.
Alavi S, Yaraghi N. The effect of fluoride varnish and chlorhexidine gel on white spots and gingival and plaque indices in fixed orthodontic patients: A placebo-controlled study. Dent Res J (Isfahan). 2018 Jul-Aug;15(4):276-282.
Priya BM, Anitha V, Shanmugam M, Ashwath B, Sylva SD, Vigneshwari SK. Efficacy of chlorhexidine and green tea mouthwashes in the management of dental plaque-induced gingivitis: A comparative clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):505-9. doi: 10.4103/0976-237X.169845.
Zuttion GS, Juarez HAB, Lima BD, Assumpcao DP, Daneris AP, Tuchtenhagen IH, Casarin M, Muniz FWMG. Comparison of the anti-plaque and anti-gingivitis efficacy of Chlorhexidine and Malva mouthwashes: Randomized crossover clinical trial. J Dent. 2024 Nov;150:105313. doi: 10.1016/j.jdent.2024.105313. Epub 2024 Aug 22.
Atassi F, Awartani F. Oral hygiene status among orthodontic patients. J Contemp Dent Pract. 2010 Jul 1;11(4):E025-32.
Other Identifiers
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KMU/DIR/CTU/2025/005
Identifier Type: -
Identifier Source: org_study_id
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