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Completed

NCT Number: NCT07490873

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

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.

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Key information

Conditions

Effectiveness of Chlorohexidine Effectiveness of Cetylpyridinium Chloride Effectiveness of Essential Oil

Age range

14 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, University of Baghdad

Baghdad, Baghdad Governorate, Iraq

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Plaque index (PI)

    Time frame: 10 weeks

    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.

  2. Gingival index (GI)

    Time frame: 10 weeks

    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.

  3. Salivary interleukin-1 beta (IL-1β) levels

    Time frame: 10 weeks

    Quantified using an enzyme-linked immunosorbent assay (ELISA) to assess inflammatory response before and after each intervention phase.

Secondary outcomes

  1. Bleeding on probing (BOP)

    Time frame: 10 weeks

    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).

  2. Tolerability (VAS) scale

    Time frame: 10 weeks

    • Visual analog scale(VAS) scores (0-10) for taste acceptability, burning sensation, and mucosal irritation. ( 0 = no means no pain, 10 = worst possible pain).

  3. Patient satisfaction (Likert scale)

    Time frame: 10 weeks

    Assessed via a short-structured questionnaire (Likert-scale format) after each intervention period:

    • Very dissatisfied
    • Dissatisfied
    • Neutral
    • Satisfied
    • Very satisfied

  4. Adverse events

    Time frame: 10 weeks

    Clinical observation for staining, ulceration, or desquamation.(Yes/NO)

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.