Inflammation in Clear Aligners With and Without Attachments

NCT07506993 | Recruiting

• 1 other identifier: 0171-26-EP
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

inflammation; orthodontics

Outcome Measures

Primary Outcomes (1)

• IL-1B

  Measure of IL-1B at molar sites

  Day 1

Study Arms (2)

Attachments

Clear aligner with molar attachment users

No attachments

Clear aligners without molar attachment users

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center College of Dentistry

Lincoln, Nebraska, 68358, United States

RECRUITING

Related Publications (8)

• Kredig C, Peuckert E, Schmidtmann I, Drechsler T, Erbe C. Oral health in adolescents: periodontal inflammatory biomarkers during orthodontic clear aligner therapy. Clin Oral Investig. 2025 Mar 5;29(3):168. doi: 10.1007/s00784-025-06212-9.

  PMID: 40042542 BACKGROUND

• Shokeen B, Viloria E, Duong E, Rizvi M, Murillo G, Mullen J, Shi B, Dinis M, Li H, Tran NC, Lux R, Wu T. The impact of fixed orthodontic appliances and clear aligners on the oral microbiome and the association with clinical parameters: A longitudinal comparative study. Am J Orthod Dentofacial Orthop. 2022 May;161(5):e475-e485. doi: 10.1016/j.ajodo.2021.10.015. Epub 2022 Mar 2.

  PMID: 35248417 BACKGROUND

• Perinetti G, Paolantonio M, D'Attilio M, D'Archivio D, Tripodi D, Femminella B, Festa F, Spoto G. Alkaline phosphatase activity in gingival crevicular fluid during human orthodontic tooth movement. Am J Orthod Dentofacial Orthop. 2002 Nov;122(5):548-56. doi: 10.1067/mod.2002.126154.

  PMID: 12439484 BACKGROUND

• Rouzi M, Zhang X, Jiang Q, Long H, Lai W, Li X. Impact of Clear Aligners on Oral Health and Oral Microbiome During Orthodontic Treatment. Int Dent J. 2023 Oct;73(5):603-611. doi: 10.1016/j.identj.2023.03.012. Epub 2023 Apr 25.

  PMID: 37105789 BACKGROUND

• Xu M, Li G, Tian J, Xie F, Zuo J, Hu J, Yin K, Wang W. Comparison of the effects of clear aligners and fixed appliances on the oral microbiota and reactive oxygen species: a prospective study. Front Cell Infect Microbiol. 2026 Jan 23;15:1738047. doi: 10.3389/fcimb.2025.1738047. eCollection 2025.

  PMID: 41659811 BACKGROUND

• Sioustis IA, Martu MA, Aminov L, Pavel M, Cianga P, Kappenberg-Nitescu DC, Luchian I, Solomon SM, Martu S. Salivary Metalloproteinase-8 and Metalloproteinase-9 Evaluation in Patients Undergoing Fixed Orthodontic Treatment before and after Periodontal Therapy. Int J Environ Res Public Health. 2021 Feb 8;18(4):1583. doi: 10.3390/ijerph18041583.

  PMID: 33567492 BACKGROUND

• Kamran MA, Alnazeh AA, Almagbol M, Almoammar S, Alhaizaey AHA, Alshahrani I. Role of six cytokines and bone metabolism biomarkers in gingival crevicular fluid in patients undergoing fixed orthodontic appliance treatment in comparison with aligners: a clinical study. Angle Orthod. 2023 May 1;93(3):335-340. doi: 10.2319/091722-649.1.

  PMID: 36807401 BACKGROUND

• Gujar AN, Baeshen HA, Alhazmi A, Bhandi S, Raj AT, Patil S, Birkhed D. Cytokine levels in gingival crevicular fluid during orthodontic treatment with aligners compared to conventional labial fixed appliances: a 3-week clinical study. Acta Odontol Scand. 2019 Aug;77(6):474-481. doi: 10.1080/00016357.2019.1607548. Epub 2019 Apr 26.

  PMID: 31027423 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gingival crevicular fluid samples from molars

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Amy C Killeen, DDS, MS

CONTACT

402-472-7948; akilleen@unmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)