Recruiting

Clear Aligners & Attachments

Sponsor:

University of Nebraska

Code:

NCT07506993

Conditions

Periodontal Inflammation

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Periodontal Inflammation

Study ID

NCT07506993

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • orthodontic patient at the UNMC College of dentistry
  • clear aligner therapy

Exclusion Criteria:

  • pregnancy

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Attachments

Clear aligner with molar attachment users

No attachments

Clear aligners without molar attachment users

Primary outcome measure

  • IL-1B [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Amy C Killeen, DDS, MS

402-472-7948akilleen@unmc.edu

Locations

University of Nebraska Medical Center College of Dentistry

Recruiting

Lincoln, Nebraska, United States, 68358

Contacts

Amy C Killeen, DDS, MS

402-472-7948akilleen@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • inflammation
  • orthodontics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-06-16.