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

NCT07490873 | Recruiting DMC

• 1 other identifier: 1110625
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effectiveness of Chlorohexidine; Effectiveness of Essential Oil; Effectiveness of Cetylpyridinium Chloride

Keywords

Chlorohexidine; Cetylpyridinium chloride; Essential oil

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Bleeding on probing (BOP)

  10 weeks

• Tolerability (VAS) scale

  10 weeks

• Patient satisfaction (Likert scale)

  10 weeks

• Adverse events

  10 weeks

Study Arms (4)

Chlorohexidine mouthwash

EXPERIMENTAL

Chlorohexidine 0.12% mouthwash

Drug: Chlorohexidine 0.12% mouthwash

Cetylpyridinium chloride mouthwash

EXPERIMENTAL

Cetylpyridinium chloride 0.05% mouthwash

Drug: Cetylpyridinium chloride 0.05% mouthwash

Essential oil mouthwash

EXPERIMENTAL

Essential oil mouthwash

Drug: Essential Oil mouthwash

Placebo mouthwash

PLACEBO COMPARATOR

Placebo mouthwash

Other: Placebo mouthwash

Interventions

Chlorohexidine 0.12% mouthwash DRUG

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.

Chlorohexidine mouthwash

Cetylpyridinium chloride 0.05% mouthwash DRUG

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.

Cetylpyridinium chloride mouthwash

Essential Oil mouthwash DRUG

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.

Essential oil mouthwash

Placebo mouthwash OTHER

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.

Placebo mouthwash

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Baghdad Governorate, Iraq

RECRUITING

MeSH Terms

Interventions

Mouthwashes; Cetylpyridinium

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mustafa Saber Alkhashan, B.D.S

CONTACT

+9647722062820; mostafa.saber2405@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blind design in which the participants, the examiner, and the analyst/statistician all will be blinded to the identity of the mouthwash. The supervisor is the only person aware of the mouthwash identity, she will use empty bottles of the same size and shape for the interventions, label them with English letters(A, B, C, D), and distribute them according to a randomized sequence generated using a computer program. The examiner will follow the treatment sequence given for every patient.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: This study is 4 arms, randomized, triple-blind, crossover clinical trial conducted among orthodontic patients with fixed appliances.

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 24, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

IR (1)