GCF Volume Changes in Aligners and Fixed Appliances (NCT07480538) | Clinical Trial Compass
CompletedNot Applicable
GCF Volume Changes in Aligners and Fixed Appliances
Turkey (Türkiye)32 participantsStarted 2025-06-03
Plain-language 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.
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Gingival Crevicular Fluid (GCF) Volume
Timeframe: Baseline (before appliance placement), 1 hour, 1 day, 1 week, and 1 month after appliance placement