Inflammation in Clear Aligners With and Without Attachments

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-35
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

orthodontic patient at the UNMC College of dentistry

clear aligner therapy

Disqualifiers

pregnancy

Trial population

Study population will include clear aligner orthodontic patients at the UNMC College of Dentistry aged 14-35 years old.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 2 trial groups
Group A: Attachments
Group B: No attachments

Trial outcomes

Primary outcomes

1

IL-1B

Measure of IL-1B at molar sites

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

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