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NOT YET RECRUITING
NCT07506993

Inflammation in Clear Aligners With and Without Attachments

Sponsor: University of Nebraska

View on ClinicalTrials.gov

Summary

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.

Official title: Molar-Specific Inflammatory Biomarkers in Adolescents Using Clear Aligners With and Without Attachments

Key Details

Gender

All

Age Range

14 Years - 25 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2026-05-01

Completion Date

2027-05-01

Last Updated

2026-04-02

Healthy Volunteers

No

Locations (1)

University of Nebraska Medical Center College of Dentistry

Lincoln, Nebraska, United States