GCF Volume Changes in Aligners and Fixed Appliances (GCF-OTM)

March 13, 2026 updated by: Irem TOSUN BALCI, Suleyman Demirel University

Time-Dependent Changes in Gingival Crevicular Fluid Volume During Orthodontic Tooth Movement With Clear Aligners and Fixed Appliances

Orthodontic tooth movement induces biological responses in periodontal tissues that can be reflected by changes in gingival crevicular fluid (GCF). This study aims to evaluate temporal changes in GCF volume during orthodontic treatment with clear aligners and conventional fixed appliances. GCF samples will be collected from the buccal site of tooth 12 and the palatal site of tooth 16 at baseline, 1 hour, 1 day, 1 week, and 1 month after appliance placement. The findings of this study will help to better understand periodontal tissue responses associated with different orthodontic treatment modalities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Orthodontic tooth movement is a biologically mediated process that involves a complex interaction between mechanical forces and periodontal tissue responses. The application of orthodontic forces induces a cascade of cellular and molecular events within the periodontal ligament and surrounding alveolar bone, including vascular alterations, inflammatory mediator release, and bone remodeling. These biological reactions are essential for tooth movement and can be monitored through various biochemical and clinical parameters.

Gingival crevicular fluid (GCF) represents an inflammatory exudate originating from the periodontal microcirculation and contains numerous biomarkers related to periodontal tissue metabolism and inflammatory activity. Because of its non-invasive collection method and its close relationship with periodontal tissue responses, GCF has been widely used to evaluate biological processes associated with orthodontic tooth movement.

In recent years, clear aligner therapy has become an increasingly popular alternative to conventional fixed orthodontic appliances. Clear aligners deliver orthodontic forces through removable thermoplastic appliances that apply intermittent forces during tooth movement. In contrast, conventional fixed appliances provide more continuous force application through brackets and archwires. These biomechanical differences may influence the magnitude and temporal characteristics of periodontal tissue responses during orthodontic treatment.

Although several studies have investigated biochemical changes in GCF during orthodontic tooth movement, limited evidence exists regarding temporal changes in GCF volume and whether different orthodontic treatment modalities produce distinct patterns of GCF volume alteration. Understanding these biological responses may provide further insight into periodontal tissue adaptation during orthodontic therapy.

The aim of this prospective clinical study is to evaluate and compare temporal changes in gingival crevicular fluid volume during orthodontic treatment with clear aligners and conventional fixed appliances.

Participants undergoing orthodontic treatment will be assigned to either a clear aligner group or a conventional fixed appliance group. Gingival crevicular fluid samples will be collected from two standardized sampling sites: the buccal aspect of tooth 12 and the palatal aspect of tooth 16. Sampling will be performed at five time points: baseline (prior to appliance placement), 1 hour, 1 day, 1 week, and 1 month following appliance placement.

GCF volume will be measured using a Periotron device, which provides quantitative assessment of fluid volume collected from the gingival crevice. The collected data will be used to analyze temporal patterns of GCF volume changes and to compare potential differences between orthodontic treatment modalities.

The findings of this study are expected to contribute to a better understanding of periodontal tissue responses during orthodontic tooth movement and to provide additional biological insight into the effects of different orthodontic appliance systems.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Isparta, Turkey (Türkiye), 32260
        • Suleyman Demirel University Faculty of Dentistry Department of Periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Systemically healthy individuals with no history of systemic disease
  • No regular pharmacological medication use within the last 6 months
  • Individuals with completed mixed dentition and full permanent dentition (excluding third molars)
  • No missing or impacted teeth other than third molars
  • Indication for non-extraction orthodontic treatment
  • Mild malocclusion with 2-4 mm crowding (Celikoglu, 2010)
  • Skeletal Class I relationship (0° ≤ ANB ≤ 4°)
  • Periodontally healthy individuals (gingival index <1, plaque index <1, probing depth ≤3 mm, <10% bleeding on probing, and no radiographic bone loss)
  • No caries, fractures, wear, or restorations in the teeth selected for gingival crevicular fluid sampling
  • Absence of parafunctional habits that could cause traumatic oral lesions

Exclusion Criteria:

  • Presence of periodontal disease or radiographic bone loss
  • Poor oral hygiene
  • Skeletal anomalies or need for orthognathic treatment
  • Temporomandibular joint disorders
  • Known allergy to any medication or material
  • Tobacco or alcohol use
  • Personal or family history of cancer or history of chemotherapy/radiotherapy
  • Participation in another clinical trial during the study period
  • Presence of mixed dentition or missing teeth other than third molars

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clear Aligner
Orthodontic treatment performed using clear aligner therapy.
Device: Clear Aligner Therapy
Orthodontic treatment performed using removable clear aligner appliances that deliver controlled orthodontic forces for tooth movement. Participants will wear sequential aligners according to the treatment protocol, and gingival crevicular fluid samples will be collected at predefined time points to evaluate temporal changes in GCF volume.
Active Comparator: Fixed Appliance
Orthodontic treatment performed using conventional fixed orthodontic appliances.
Device: Fixed Appliance
Orthodontic treatment performed using conventional fixed orthodontic appliances consisting of brackets and archwires to apply continuous orthodontic forces for tooth movement. Gingival crevicular fluid samples will be collected at predefined time points to evaluate temporal changes in GCF volume during treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gingival Crevicular Fluid (GCF) Volume
Time Frame: Baseline (before appliance placement), 1 hour, 1 day, 1 week, and 1 month after appliance placement
Gingival crevicular fluid (GCF) samples will be collected from the buccal site of tooth 12 and the palatal site of tooth 16 using sterile absorbent paper strips. The volume of GCF will be measured with a Periotron device. This measurement will be used to evaluate temporal changes in gingival crevicular fluid volume as an indicator of periodontal tissue response during orthodontic treatment with clear aligners and conventional fixed appliances.
Baseline (before appliance placement), 1 hour, 1 day, 1 week, and 1 month after appliance placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Actual)

February 11, 2026

Study Completion (Actual)

March 3, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUU-2025-681-10-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study dataset contains identifiable clinical information and data sharing was not included in the original participant consent or ethics approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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