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

NCT07119840 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2025/005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingivitis; Dental Plaque

Keywords

Listerine; Chlorhexidine; Gingival Index; Plaque Index; Oral Hygiene; Orthodontic Appliances

Outcome Measures

Primary Outcomes (2)

• Gingival Index (GI)

  Measured using standard GI scale (Grades 0-3)

  baseline, 2 weeks, and 4 weeks , 8 week

• Plaque Index (PI)

  Measured using Orthodontic Plaque Index (Grades 0-4)

  baseline, 2 weeks, and 4 weeks , 8 week

Secondary Outcomes (1)

• Side effects

  Baseline till 8 weeks

Study Arms (2)

Listerine Group

EXPERIMENTAL

Participants will receive Listerine mouthwash in unlabelled bottles once daily for 4 weeks.

Drug: Listerine Mouthwash Product

Chlorhexidine Group

ACTIVE COMPARATOR

Participants will receive chlorhexidine mouthwash in unlabelled bottles once daily for 4 weeks.

Drug: Chlorhexidine mouthwash

Interventions

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.

Also known as: Essential Oil Mouthwash

Listerine Group

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.

Also known as: CHX Mouthwash

Chlorhexidine Group

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• Saidu College of Dentistry: collaborator

Study Sites (1)

Saidu College of Dentistry

Swāt, KPK, Pakistan

RECRUITING

Related Publications (5)

• 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.

  PMID: 31001394 BACKGROUND

• 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.

  PMID: 30123305 BACKGROUND

• 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.

  PMID: 26681856 BACKGROUND

• 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.

  PMID: 39173823 BACKGROUND

• Atassi F, Awartani F. Oral hygiene status among orthodontic patients. J Contemp Dent Pract. 2010 Jul 1;11(4):E025-32.

  PMID: 20953561 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Fazli Rabi, MPH*

  Khyber Medical University

  PRINCIPAL INVESTIGATOR

• Dr Naveed Sadiq, PhD

  Khyber Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fazli Rabi, MPH*

CONTACT

+92 307 5663219; fazlirabi804@gmail.com

Dr Naveed Sadiq, PhD

CONTACT

+92 334 9777904; sadiq@kmu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be randomly assigned to either the Chlorhexidine or Listerine group using a block randomization method. To ensure blinding, both mouthwashes will be dispensed in identical, unlabelled bottles. Neither the participants, the care providers will be aware of the group allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm, parallel group design where participants are randomly assigned to receive either Chlorhexidine or Listerine mouthwash for 4 weeks. Each participant remains in their assigned intervention group throughout the study without crossover.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: August 1, 2025
• Primary Completion: November 29, 2025
• Study Completion: December 30, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)