Orthodontic RetainersNCT07801768
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
An observational study of Orthodontic Retainers and Tooth Mobility, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this prospective clinical study is to comparatively evaluate the long-term stability of teeth, physiological tooth mobility, and effects on periodontal tissues of three different fixed lingual retainer materials used to prevent relapse following orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retainers, Tooth Mobility
- What is being tested?
- Mobility measurement with Periotest device and Digital intraoral impression
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 1 Mar 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.
Who may be able to join
- Patients who have undergone fixed orthodontic treatment at the Department of Orthodontics, Faculty of Dentistry, Marmara University, and whose treatment is nearing completion
- Patients whose treatment duration is between 2 and 3 years
- Patients with healthy periodontal tissue (plaque index and gingival index <1; bleeding on probing <10 per cent; no clinical attachment loss)
- Patients aged between 18 and 35
- Systemically healthy individuals
- Patients with deep bite for whom Nitinol wire retainers, manufactured using CAD/CAM technology and capable of being fitted without occlusal contact due to their adaptability to the occlusion, have been applied
- Patients for whom impressions cannot be taken to fabricate a retainer
- Patients without deep bite or a gag reflex who have had a standard retainer fitted
Who cannot join
- Patients who have undergone orthodontic treatment at another clinic
- Patients whose treatment lasted longer than 3 years or less than 2 years
- Patients with a cleft lip and palate or a related syndrome
- Patients with caries or dental prostheses on the teeth where the retainer is to be bonded
- Smokers
- Individuals with missing anterior teeth
- Individuals taking systemic medication that affects the immune system or may affect periodontal health (e.g. steroids)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this prospective clinical study is to comparatively evaluate the long-term stability of teeth, physiological tooth mobility, and effects on periodontal tissues of three different fixed lingual retainer materials used to prevent relapse following orthodontic treatment. A total of 80 participants whose orthodontic treatment is completed will be randomly and equally distributed into four groups as one control (n=20) and three study groups (n=20 each): Group 1 will receive CAD/CAM-fabricated 0.016-inch Nitinol wire; Group 2 will receive manually bent multi- strand 0.0215-inch stainless steel wire; and Group 3 will receive 0.030-inch stainless steel chain retainers. Control group will be 20 samples. Clinical and radiographic measurements will be performed at the day of debonding (T0) and at a 6-month follow-up (T1). Physiological tooth mobility will be measured objectively using a Periotest device. Relapse amounts will be assessed by superimposing intraoral digital scans via Nemocast software using Little's Irregularity Index, and the 6-month failure/breakage rates of the retainers will be recorded. The null hypothesis states that there is no statistically significant difference among the different retainer materials regarding tooth stability, relapse, and physiological mobility.
- Conditions
- Orthodontic Retainers, Tooth Mobility
- Being tested
- Mobility measurement with Periotest device, Digital intraoral impression
- Medical subject headings
- Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility measurement with Periotest deviceDiagnostic test
T0 Mobility measurement with Periotest device after orthodontic treatment finished; before retainer simantation and after simantation. T1 Mobility measurement with Periotest device 6 months later; with retainer and without retainer.
Digital intraoral impressionDiagnostic test
T0 digital dental models will be taken with 3D scanner after orthodontic treatment finished; after retainer simantation. T1 digital dental models will be taken 6 months later with retainer. And Little irregularity index, arch length measurement will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 1. Control | healthy gingiva, no smoking, non-pregnant, age:18-35, patients did not receive any orthodontic treatment and don't have bruxism and syndrome Receives: Diagnostic Test: Mobility measurement with Periotest device; Diagnostic Test: Digital intraoral impression | |
| 2. CAD-CAM Nitinol wire (Memotain) | Just finished orthodontic treatment, healthy gingiva, no smoking, non-pregnant, age:18-35, patients don't have bruxism and syndrome Receives: Diagnostic Test: Mobility measurement with Periotest device; Diagnostic Test: Digital intraoral impression | |
| 3. Manually bent 6 multi- strand 0.0215-inch stainless steel wire | Just finished orthodontic treatment, healthy gingiva, no smoking, non-pregnant, age:18-35, patients don't have bruxism and syndrome Receives: Diagnostic Test: Mobility measurement with Periotest device; Diagnostic Test: Digital intraoral impression | |
| 4. 0.030-inch stainless steel chain | Just finished orthodontic treatment, healthy gingiva, no smoking, non-pregnant, age:18-35, patients don't have bruxism and syndrome Receives: Diagnostic Test: Mobility measurement with Periotest device; Diagnostic Test: Digital intraoral impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth mobility
Tooth mobility will be assessed using the Periotest device. The device will be applied to the buccal surface of the tooth, and the Periotest value (PTV) will be recorded according to the manufacturer's instructions. Higher PTV values indicate greater tooth mobility. Measurements will be recorded as Periotest values (PTV).
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
Little irregularity
Anterior dental irregularity will be assessed using Little's Irregularity Index, measured as the sum of the five linear displacements between the anatomic contact points of the mandibular anterior teeth, in millimeters (mm). This assessment will be performed on digital intraoral models by using Orthomodel (Orthomodel, İstanbul, Türkiye) software.
Measured: From enrollment to the end of treatment at 6 months
Arch length
Dental arch length will be assessed by measuring the linear distance from the midpoint between the central incisors to a line connecting the distal surfaces of the first permanent molars, in millimeters (mm). This assessment will be performed on digital intraoral models by using Orthomodel (Orthomodel, İstanbul, Türkiye) software.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 Jun 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthodontic RetainersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gulden karabiber, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801768
- Sponsor's protocol ID
- GKAY-ret
- Status last verified
- Jun 2026
- First submitted
- 19 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Kucuk EB, Celik Guler O, Fatih Arpag O, Eren HK. Effect of different fixed lingual retainers on tooth mobility: prospective clinical study. Acta Odontol Scand. 2025 Dec 10;84:577-582. doi: 10.2340/aos.v84.44808.
PubMed 41369988Kucera J, Marek I, Littlewood SJ. The effect of different bonded retainer wires on tooth mobility immediately after orthodontic treatment. Eur J Orthod. 2022 Mar 30;44(2):178-186. doi: 10.1093/ejo/cjab038.
PubMed 34374751Tanaka E, Ueki K, Kikuzaki M, Yamada E, Takeuchi M, Dalla-Bona D, Tanne K. Longitudinal measurements of tooth mobility during orthodontic treatment using a periotest. Angle Orthod. 2005 Jan;75(1):101-5. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
PubMed 15747823
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
- ClinicalTrials.gov ID
- NCT07801768
- Acronym / sponsor ID
- GKAY-ret
- Conditions
- Orthodontic Retainers, Tooth Mobility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Sep 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.
The purpose of this prospective clinical study is to comparatively evaluate the long-term stability of teeth, physiological tooth mobility, and effects on periodontal tissues of three different fixed lingual retainer materials used to prevent relapse following orthodontic treatment. A total of 80 participants whose orthodontic treatment is completed will be randomly and equally distributed into four groups as one control (n=20) and three study groups (n=20 each): Group 1 will receive CAD/CAM-fabricated 0.016-inch Nitinol wire; Group 2 will receive manually bent multi- strand 0.0215-inch stainless steel wire; and Group 3 will receive 0.030-inch stainless steel chain retainers. Control group will be 20 samples. Clinical and radiographic measurements will be performed at the day of debonding (T0) and at a 6-month follow-up (T1). Physiological tooth mobility will be measured objectively using a Periotest device. Relapse amounts will be assessed by superimposing intraoral digital scans via Nemocast software using Little's Irregularity Index, and the 6-month failure/breakage rates of the retainers will be recorded. The null hypothesis states that there is no statistically significant difference among the different retainer materials regarding tooth stability, relapse, and physiological mobility.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Control | – | Diagnostic Test: Mobility measurement with Periotest device, Diagnostic Test: Digital intraoral impressionhealthy gingiva, no smoking, non-pregnant, age:18-35, patients did not receive any orthodontic treatment and don't have bruxism and syndrome |
| 2. CAD-CAM Nitinol wire (Memotain) | – | Diagnostic Test: Mobility measurement with Periotest device, Diagnostic Test: Digital intraoral impressionJust finished orthodontic treatment, healthy gingiva, no smoking, non-pregnant, age:18-35, patients don't have bruxism and syndrome |
| 3. Manually bent 6 multi- strand 0.0215-inch stainless steel wire | – | Diagnostic Test: Mobility measurement with Periotest device, Diagnostic Test: Digital intraoral impressionJust finished orthodontic treatment, healthy gingiva, no smoking, non-pregnant, age:18-35, patients don't have bruxism and syndrome |
| 4. 0.030-inch stainless steel chain | – | Diagnostic Test: Mobility measurement with Periotest device, Diagnostic Test: Digital intraoral impressionJust finished orthodontic treatment, healthy gingiva, no smoking, non-pregnant, age:18-35, patients don't have bruxism and syndrome |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.
Key inclusion criteria (8 listed)
- Patients who have undergone fixed orthodontic treatment at the Department of Orthodontics, Faculty of Dentistry, Marmara University, and whose treatment is nearing completion
- Patients whose treatment duration is between 2 and 3 years
- Patients with healthy periodontal tissue (plaque index and gingival index <1; bleeding on probing <10 per cent; no clinical attachment loss)
- Patients aged between 18 and 35
- Systemically healthy individuals
Key exclusion criteria (8 listed)
- Patients who have undergone orthodontic treatment at another clinic
- Patients whose treatment lasted longer than 3 years or less than 2 years
- Patients with a cleft lip and palate or a related syndrome
- Patients with caries or dental prostheses on the teeth where the retainer is to be bonded
- Smokers
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 |
|---|---|---|
| Mobility measurement with Periotest deviceT0 Mobility measurement with Periotest device after orthodontic treatment finished; before retainer simantation and after simantation. T1 Mobility measurement with Periotest device 6 months later; with retainer and without retainer. | Diagnostic test | 1. Control, 2. CAD-CAM Nitinol wire (Memotain), 3. Manually bent 6 multi- strand 0.0215-inch stainless steel wire, 4. 0.030-inch stainless steel chain |
| Digital intraoral impressionT0 digital dental models will be taken with 3D scanner after orthodontic treatment finished; after retainer simantation. T1 digital dental models will be taken 6 months later with retainer. And Little irregularity index, arch length measurement will be performed. | Diagnostic test | 1. Control, 2. CAD-CAM Nitinol wire (Memotain), 3. Manually bent 6 multi- strand 0.0215-inch stainless steel wire, 4. 0.030-inch stainless steel chain |
Primary outcome
Tooth mobility
Time frame: From enrollment to the end of treatment at 6 months
Tooth mobility will be assessed using the Periotest device. The device will be applied to the buccal surface of the tooth, and the Periotest value (PTV) will be recorded according to the manufacturer's instructions. Higher PTV values indicate greater tooth mobility. Measurements will be recorded as Periotest values (PTV).
2 secondary outcomes
Little irregularity
Time frame: From enrollment to the end of treatment at 6 months
Arch length
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Background: PubMed 41369988Kucuk EB, Celik Guler O, Fatih Arpag O, Eren HK. Effect of different fixed lingual retainers on tooth mobility: prospective clinical study. Acta Odontol Scand. 2025 Dec 10;84:577-582. doi: 10.2340/aos.v84.44808.
- Background: PubMed 34374751Kucera J, Marek I, Littlewood SJ. The effect of different bonded retainer wires on tooth mobility immediately after orthodontic treatment. Eur J Orthod. 2022 Mar 30;44(2):178-186. doi: 10.1093/ejo/cjab038.
- Background: PubMed 15747823Tanaka E, Ueki K, Kikuzaki M, Yamada E, Takeuchi M, Dalla-Bona D, Tanne K. Longitudinal measurements of tooth mobility during orthodontic treatment using a periotest. Angle Orthod. 2005 Jan;75(1):101-5. doi: 10.1043/0003-3219(2005)0752.0.CO;2.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Orthodontic Retainers and Tooth Mobility, run by Marmara 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 8 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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?
This study is still under way. Results are not available in the source record yet.
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?
Tooth mobility (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07801768, which also lists 3 linked publications.
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 24 Sep 2026.