Does the clear aligner edge shape change gum bacteria during finishing orthodontic treatment?
The Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota Composition During Orthodontic Treatment: A Prospective Longitudinal Split-Mouth Study.
NA · George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures · NCT07533058
This trial will test whether two different clear aligner edge designs change the kinds and amounts of bacteria near the gumline in people finishing clear aligner treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures (other) |
| Locations | 1 site (Sibiu, Sibiu County) |
| Trial ID | NCT07533058 on ClinicalTrials.gov |
What this trial studies
This is a split-mouth interventional comparison where each participant wears two finishing CA Pro tri-layer aligner edge designs simultaneously (one design on one arch and the other design on the opposite arch). The supragingival design covers about 2 mm of gum tissue while the juxtagingival festooned design follows the gum margin without covering tissue. Subgingival plaque samples will be collected at baseline and after 4 and 8 weeks of wear to measure levels of periodontal pathogens and microbiota changes. The trial tests whether covering the gingival margin with the aligner edge creates a microenvironment that favors anaerobic, disease-associated bacteria.
Who should consider this trial
Good fit: People aged 15 or older who are in the finishing phase of clear aligner orthodontic treatment, have permanent dentition, and have healthy gums at baseline (probing depths ≤3 mm and no bleeding at index sites) are ideal candidates.
Not a fit: Patients with active periodontal disease, recent antibiotic use, systemic conditions affecting gums, habitual mouth breathing, or poorly adapted adjacent restorations are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could guide clinicians to choose an aligner trimming-line that reduces growth of gum-disease–associated bacteria during the finishing phase, potentially protecting gum health.
How similar studies have performed: While broader research has examined clear aligners and periodontal outcomes, direct split-mouth comparisons of supragingival versus juxtagingival trimming-line effects on subgingival microbiota are novel and not previously established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Permanent dentition (excluding third molars) * Age 15 years or older at enrollment * Currently undergoing the finishing phase of orthodontic treatment with clear aligners * Residual planned tooth movements no greater than 0.5 mm per tooth per aligner stage * Absence of active periodontal disease at baseline: probing depth 3 mm or less at all sites, and no bleeding on probing at index sampling sites * Written informed consent; for participants aged 15-17 years, written consent from parent or legal guardian is also required Exclusion Criteria: * Systemic conditions known to affect periodontal tissues (e.g., uncontrolled diabetes mellitus, immunosuppressive therapy) * Antibiotic therapy within the 3 months preceding enrollment * Active gingivitis (modified gingival index 2 or greater) or periodontitis at baseline * Habitual mouth breathing (self-reported or clinically assessed) * Poorly adapted fixed prosthetic restorations adjacent to planned index sampling sites * Visible plaque at more than 50% of tooth surfaces at baseline * Self-reported aligner compliance below 22 hours per day during the study period * Pregnancy or breastfeeding
Where this trial is running
Sibiu, Sibiu County
- Aorys Clinic — Sibiu, Sibiu County, Romania (RECRUITING)
Study contacts
- Principal investigator: EMILIA RUSU (PRODEA), DDS, Specialist Orthodontist — George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, 38 Gheorghe Marinescu Street, 540139 Targu Mures, Romania
- Study coordinator: EMILIA RUSU (PRODEA), DDS, Specialist Orthodontist
- Email: rusu.emilia.24@stud.umfst.ro
- Phone: +40756607316
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.
Conditions: Periodontal Diseases, Malocclusion, Oral Health, clear aligners, trimming line, periodontal pathogens, split-mouth design, finishing orthodontic treatment