Orthodontic Tooth MovementGCF-OTMNCT07480538
GCF Volume Changes in Aligners and Fixed Appliances
A study testing Clear Aligner Therapy and Fixed Appliance in people with Orthodontic Tooth Movement, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement
- What is being tested?
- Clear Aligner Therapy and Fixed Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2025to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University Faculty of Dentistry Department of Periodontology
Isparta, 32260
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthodontic Tooth Movement
- Being tested
- Clear Aligner Therapy, Fixed Appliance
- Keywords
- Orthodontic Tooth Movement, Gingival Crevicular Fluid, Clear Aligners, Fixed Orthodontic Appliances, Periodontal Tissue Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Aligner TherapyDevice
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.
Fixed ApplianceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Clear Aligner | Experimental | Orthodontic treatment performed using clear aligner therapy. Receives: Device: Clear Aligner Therapy |
| Fixed Appliance | Active comparator | Orthodontic treatment performed using conventional fixed orthodontic appliances. Receives: Device: Fixed Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before appliance placement), 1 hour, 1 day, 1 week, and 1 month after appliance placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start3 Jun 2025
- Primary completion11 Feb 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Tooth MovementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem TOSUN BALCI, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480538
- Sponsor's protocol ID
- BUU-2025-681-10-19
- Acronym
- GCF-OTM
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Dependent Changes in Gingival Crevicular Fluid Volume During Orthodontic Tooth Movement With Clear Aligners and Fixed Appliances
- ClinicalTrials.gov ID
- NCT07480538
- Acronym / sponsor ID
- GCF-OTM / BUU-2025-681-10-19
- Conditions
- Orthodontic Tooth Movement
- Keywords
- Orthodontic Tooth Movement, Gingival Crevicular Fluid, Clear Aligners, Fixed Orthodontic Appliances, Periodontal Tissue Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clear Aligner | Experimental | Device: Clear Aligner TherapyOrthodontic treatment performed using clear aligner therapy. |
| Fixed Appliance | Active comparator | Device: Fixed ApplianceOrthodontic treatment performed using conventional fixed orthodontic appliances. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear Aligner TherapyOrthodontic 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. | Device | Clear Aligner |
| Fixed ApplianceOrthodontic 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. | Device | Fixed Appliance |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligner Therapy and Fixed Appliance in people with Orthodontic Tooth Movement, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.