Inflammation in Clear Aligners With and Without Attachments

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT07506993
Status
Not Yet Recruiting

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Conditions

  • Periodontal Inflammation

Eligibility Criteria

Sex
ALL
Age
14 Years - 25 Years
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
May 1, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Attachments
    Clear aligner with molar attachment users
  • Arm: No attachments
    Clear aligners without molar attachment users

Primary Outcome Measure

IL-1B [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical Center College of DentistryLincolnNebraska68358-

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University of Nebraska Medical Center College of Dentistry· Lincoln, NE

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