GCF Volume Changes in Aligners and Fixed Appliances

NCT07480538 | Completed

• 1 other identifier: BUU-2025-681-10-19
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthodontic Tooth Movement

Keywords

Orthodontic Tooth Movement; Gingival Crevicular Fluid; Clear Aligners; Fixed Orthodontic Appliances; Periodontal Tissue Response

Outcome Measures

Primary Outcomes (1)

• Change in Gingival Crevicular Fluid (GCF) Volume

  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

Study Arms (2)

Clear Aligner

EXPERIMENTAL

Orthodontic treatment performed using clear aligner therapy.

Device: Clear Aligner Therapy

Fixed Appliance

ACTIVE COMPARATOR

Orthodontic treatment performed using conventional fixed orthodontic appliances.

Device: Fixed Appliance

Interventions

Clear Aligner Therapy DEVICE

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.

Clear Aligner

Fixed Appliance DEVICE

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.

Fixed Appliance

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University Faculty of Dentistry Department of Periodontology

Isparta, 32260, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator responsible for statistical analysis will be blinded to the treatment allocation of participants. Data will be coded prior to analysis to ensure that the outcome assessor remains unaware of group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will receive orthodontic treatment with either clear aligners or conventional fixed appliances. Gingival crevicular fluid samples will be collected from predefined sites at multiple time points to evaluate temporal changes in GCF volume during orthodontic tooth movement.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: June 3, 2025
• Primary Completion: February 11, 2026
• Study Completion: March 3, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)