Actively Recruiting

Phase Not Applicable
Age: 14Years - 30Years
All Genders
NCT07490873

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

Led by University of Baghdad · Updated on 2026-03-24

24

Participants Needed

1

Research Sites

38 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 14Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 to 30 years
  • Wearing fixed orthodontic braces (metal brackets and archwires) currently in the alignment stage
  • Able and willing to attend all study visits and follow study procedures including washout periods and mouthwash use
  • Baseline oral health after preparation with plaque index 3 1.0 and gingival index 3 0.5
  • Bleeding on probing less than 10%
  • Systemically healthy with no antibiotic or other medication use in the past 3 months
  • Willing to avoid any other mouthwash or antimicrobial oral hygiene products besides study mouthwash and regular toothpaste
  • Provide written informed consent (and parental consent if under legal age)
Not Eligible

You will not qualify if you...

  • Having periodontitis or untreated dental caries needing urgent care
  • Smoking or using tobacco/nicotine products including vaping
  • Allergy or sensitivity to chlorhexidine, cetylpyridinium chloride, essential oil components, or any study mouthwash ingredients
  • Pregnancy or breastfeeding
  • Use of antiseptic mouthwash, oral probiotics, or antimicrobial gel within 3 months before baseline

AI-Screening

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Trial Site Locations

Total: 1 location

1

College of Dentistry, University of Baghdad

Baghdad, Baghdad Governorate, Iraq

Actively Recruiting

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Research Team

M

Mustafa Saber Alkhashan, B.D.S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

4

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