Comparing three antiseptic mouthwashes for people with fixed braces
Antiplaque Efficacy and Patient Reported Outcome of Chlorohexidine, Cetylpyridinium Chloride, and Essential Oil Mouthwashes in Orthodontic Patients: A Randomized Crossover Clinical Trial
This study will test whether chlorhexidine, cetylpyridinium chloride, or an essential-oil mouthwash works better than a placebo at reducing plaque, lowering salivary IL-1β, and improving how people aged 14–30 with fixed orthodontic braces feel about their oral health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 14 Years to 30 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Locations | 1 site (Baghdad, Baghdad Governorate) |
| Trial ID | NCT07490873 on ClinicalTrials.gov |
What this trial studies
Participants aged 14–30 who are wearing fixed orthodontic appliances will first complete a one-month preparatory phase with professional cleaning to standardize baseline oral health. After the preparatory phase, participants will be assigned to one of four mouthwash groups (chlorhexidine 0.12%, cetylpyridinium chloride 0.05%, essential oil, or placebo) and instructed to use the assigned product while refraining from other antiseptic mouthwashes. The study will compare clinical periodontal measures, salivary IL-1β levels, and patient-reported outcomes between groups. Results will show whether any of the active mouthwashes provide superior antiplaque or anti-inflammatory effects and better patient-reported experience compared with placebo.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy individuals aged 14–30 who are in the alignment stage of fixed orthodontic appliance therapy, can attend all visits, and meet baseline plaque and gingival index thresholds after the preparatory cleaning.
Not a fit: Patients with periodontitis, untreated urgent dental caries, current tobacco/nicotine use, recent antibiotic or certain medication use, or known allergies to mouthwash ingredients are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help people with braces choose a mouthwash that better controls plaque and reduces inflammation while improving comfort and satisfaction during orthodontic treatment.
How similar studies have performed: Previous studies have shown chlorhexidine reliably reduces plaque but can cause side effects, while cetylpyridinium chloride and essential-oil rinses have shown some antiplaque effects, though head-to-head comparisons specifically in orthodontic patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baghdad, Baghdad Governorate
- College of Dentistry, University of Baghdad — Baghdad, Baghdad Governorate, Iraq (Recruiting)
Study contacts
- Study coordinator: Mustafa Saber Alkhashan, B.D.S
- Email: mostafa.saber2405@codental.uobaghdad.edu.iq
- Phone: +9647722062820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.