Antiplaque Efficacy and Patient Reported Outcome of Chlorohexidine, Cetylpyridinium Chloride, and Essential Oil Mouthwashes in Orthodontic Patients

Antiplaque Efficacy and Patient Reported Outcome of Chlorohexidine, Cetylpyridinium Chloride, and Essential Oil Mouthwashes in Orthodontic Patients: A Randomized Crossover Clinical Trial

The goal of this clinical trial is to evaluate and compare the antiplaque efficacy and patient reported outcome of three commonly used antiseptic mouthwashes - Chlorhexidine (CHX), Cetylpyridinium Chloride (CPC), and Essential Oil (EO) formulations - in orthodontic patients undergoing fixed appliance therapy. The main question it aims to answer is:

In orthodontic patients wearing fixed appliances, what is the comparative effect of chlorhexidine, cetylpyridinium chloride, and essential-oil mouthwashes versus placebo on clinical periodontal parameters, salivary IL-1β levels, and patient-reported outcomes.

Prior to enrollment in the clinical trial, all potential participants will undergo a preparatory phase for one month aimed at achieving optimal oral health and minimizing confounding baseline inflammation. During this phase, participants will receive a full professional oral prophylaxis, including scaling and polishing, to remove dental plaque and calculus deposits. This ensures that all individuals begin the study with a comparable level of oral hygiene and gingival health.

Participants will be instructed on a standardized oral hygiene regimen, including proper toothbrushing technique using a soft-bristled toothbrush and fluoridated toothpaste twice daily. In addition, each participant will be provided with a single-tufted brush as an interproximal cleaning aid to maintain plaque control around orthodontic brackets and hard-to-reach areas. The use of any other mouthwash or adjunctive antimicrobial agent will be prohibited during this phase. After preparatory phase, participants will undergo a four-day plaque-accumulation period immediately prior to baseline clinical and biochemical assessments. During this 4-day period participants will be instructed to refrain from all mechanical oral hygiene procedures (no toothbrushing, interdental cleaning, or mouthrinse use) in order to standardize plaque formation across subjects and create a measurable baseline plaque burden for subsequent comparisons.

After that, In base line visit the salivary sample will be collected for IL-1β measurement and clinical periodontal parameters (PI,GI,BOP,PPD) will be measured and receiving oral hygiene instructions and motivation, and first intervention will be given to the patient.

After one week Saliva will be collected for IL-1β measurement and the clinical measurements ( PI,GI,BOP)will be taken, then the participant goes into washout period for two weeks, after that the participant will be called to repeat the same protocol for the remaining three interventions.

Study Overview

• Status: Recruiting
• Conditions: Effectiveness of Chlorohexidine; Effectiveness of Essential Oil; Effectiveness of Cetylpyridinium Chloride
• Intervention / Treatment: Drug: Chlorohexidine 0.12% mouthwash; Drug: Cetylpyridinium chloride 0.05% mouthwash; Drug: Essential Oil mouthwash; Other: Placebo mouthwash

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa Saber Alkhashan, B.D.S; Phone Number: +9647722062820; Email: mostafa.saber2405@codental.uobaghdad.edu.iq

Study Locations

• Iraq
  • Baghdad Governorate
    • Baghdad, Baghdad Governorate, Iraq
      • Recruiting
      • College of Dentistry, University of Baghdad
      • Contact: Baghdad Iraq; Phone Number: +96464466698; Email: master@codental.uobaghdad.edu.iq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 14-30 years.
• Wearing orthometric-type fixed orthodontic appliances(metallic brackets and archwires) and currently in alignment stage.
• Able and willing to attend all study visits and comply with study procedures, including washout periods and mouthwash use.
• Baseline oral status after preparatory phase: plaque index (Löe & Silness) ≥ 1.0 and gingival index (Löe & Silness) ≥ 0.5.
• BOP less than 10%.
• Systemically healthy individuals with no history of antibiotic use or other medications in the preceding 3 months.
• Willing to refrain from using any other mouthwash or antimicrobial oral hygiene product (except for the assigned study mouthwash and their routine toothpaste) throughout the study.
• Provide written informed consent (and parental/guardian consent if under legal age).

Exclusion Criteria:

• Periodontitis patients and untreated caries requiring urgent care.
• Smoking or use of tobacoo/nicotine products(including vaping).
• Known allergy or hypersensitivity to CHX, CPC, EO components (thymol, eucalyptol, menthol, methyl salicylate), or any ingredient in the study formulations.
• Pregnancy or breastfeeding.
• Use of any antiseptic mouthwash, oral probiotic, or antimicrobial gel in the 3 months prior to baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorohexidine mouthwash; Chlorohexidine 0.12% mouthwash	Drug: Chlorohexidine 0.12% mouthwash; Participants will rinse with 15 mL chlorhexidine gluconate 0.12% mouthwash (Kin Gingival) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after rinsing. This intervention is used as an antimicrobial mouthwash to reduce dental plaque and gingival inflammation.
Experimental: Cetylpyridinium chloride mouthwash; Cetylpyridinium chloride 0.05% mouthwash	Drug: Cetylpyridinium chloride 0.05% mouthwash; Participants will rinse with 15 mL alcohol-free cetylpyridinium chloride (CPC) 0.05% mouthwash (Kin B5) for 30 seconds twice daily for 7 days. Participants will avoid eating or drinking for 30 minutes after use. CPC acts as a quaternary ammonium antimicrobial agent that disrupts bacterial membranes.
Experimental: Essential oil mouthwash	Drug: Essential Oil mouthwash; Participants will rinse with 15 mL essential oil mouthwash (Listerine) for 30 seconds twice daily for 7 days. Participants will refrain from eating or drinking for 30 minutes after rinsing. Essential oils act by disrupting bacterial cell walls and inhibiting microbial enzyme activity.
Placebo Comparator: Placebo mouthwash	Other: Placebo mouthwash; Participants will rinse with 15 mL flavored distilled water for 30 seconds twice daily for 7 days. The placebo solution has similar appearance and flavor but contains no active antimicrobial ingredients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index (PI)	To assess supragingival plaque accumulation around orthodontic brackets before and after each intervention phase, using using Löe and Silness index on four surfaces (mesial, buccal, distal, lingual,). Each surface is normally given a score of 0 to 3 as follows: 0 = no plaque, 1 = a film of plaque adhering to the free gingival margin and adjacent area of the tooth, the plaque may be recognized only by running a probe across the tooth surface, 2 = moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, visible to the naked eye, 3 = abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.	10 weeks
Gingival index (GI)	To evaluate gingival inflammation before and after each intervention phase, using Löe and Silness index, each of the four gingival areas of the tooth is given a score from 0 to 3 as follows: 0 = Normal gingiva, 1 = Mild inflammation slight change in color, slight oedema. No bleeding on probing, 2 = Moderate inflammation-redness, oedema and glazing. Bleeding on probing, 3 = Severe inflammation marked redness and oedema, ulceration, tendency to spontaneous bleeding.	10 weeks
Salivary interleukin-1 beta (IL-1β) levels	Quantified using an enzyme-linked immunosorbent assay (ELISA) to assess inflammatory response before and after each intervention phase.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on probing (BOP)	Recorded as the percentage of sites with bleeding within 30 seconds of gentle probing, BOP will be measured by gently inserting the periodontal probe to the depth of the gingival sulcus\ periodontal pocket then removed coronally and waited for 30 seconds to observe the presence of bleeding (0 = no bleeding, 1 = presence of bleeding).	10 weeks
Tolerability (VAS) scale	- Visual analog scale(VAS) scores (0-10) for taste acceptability, burning sensation, and mucosal irritation. ( 0 = no means no pain, 10 = worst possible pain).	10 weeks
Patient satisfaction (Likert scale)	Assessed via a short-structured questionnaire (Likert-scale format) after each intervention period: Very dissatisfied; Dissatisfied; Neutral; Satisfied; Very satisfied	10 weeks
Adverse events	Clinical observation for staining, ulceration, or desquamation.(Yes/NO)	10 weeks

Collaborators and Investigators

• Sponsor: University of Baghdad

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Essential oil; Cetylpyridinium chloride; Chlorohexidine
• Additional Relevant MeSH Terms: Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chemical Actions and Uses; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Pyridinium Compounds; Cosmetics; Cetylpyridinium; Mouthwashes
• Other Study ID Numbers: 1110625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No