Inflammation in Clear Aligners With and Without Attachments
Recruiting now
Conditions studied: Periodontal Inflammation
In brief
Problem: Clear aligner therapy is widely used in orthodontics due to improved periodontal outcomes compared to fixed appliances. However, composite attachments are frequently bonded to molars to enhance biomechanics, potentially creating plaque-retentive areas that may increase localized inflammatory responses. Currently, no studies have directly compared periodontal inflammatory biomarker levels in molars treated with clear aligners with versus without attachments. This gap limits understanding of the biological impact of attachments on periodontal tissues.Hypothesis:First molars treated with clear aligners and composite attachments will demonstrate higher levels of inflammatory biomarkers in gingival crevicular fluid (GCF) compared to molars treated with clear aligners without attachments. Biomarker levels are expected to be lower in the non-attachment group. Methods: This study will include 30 orthodontic patients divided into two groups (15 per group):1. Clear aligners with molar attachments 2. Clear aligners without molar attachments. GCF samples will be collected from first molars at a routine orthodontic appointment at the UNMC College of Dentistry Graduate Orthodontic Clinic. Primary biomarkers include IL-1β, IL-6, TNF-α, and MMP-8 measured via ELISA. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Probing Depth) will also be recorded.
Key facts
- Study ID
- NCT07506993
- Run by
- University of Nebraska
- People needed
- 30
- Starts
- 2026-05-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-06-16
Who can join
Age: 14 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- orthodontic patient at the UNMC College of dentistry
- clear aligner therapy
You may not qualify if…
- pregnancy
Where it is running
- University of Nebraska Medical Center College of Dentistry — Lincoln, Nebraska, United States (enrolling)
Full record on ClinicalTrials.gov
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