- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07801768
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
August 30, 2026 updated by: gulden karabiber, Marmara University
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
80
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
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Istanbul, Turkey (Türkiye), 34784
- Marmara University
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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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
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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.
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.
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|
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
|
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.
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.
|
|
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
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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.
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.
|
|
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tooth mobility
Time Frame: From enrollment to the end of treatment at 6 months
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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).
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From enrollment to the end of treatment at 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Little irregularity
Time Frame: From enrollment to the end of treatment at 6 months
|
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.
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From enrollment to the end of treatment at 6 months
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Arch length
Time Frame: From enrollment to the end of treatment at 6 months
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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.
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From enrollment to the end of treatment at 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kucera 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.
- 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.
- Tanaka 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.
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 15, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
July 19, 2026
First Submitted That Met QC Criteria
August 30, 2026
First Posted (Actual)
September 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
August 30, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GKAY-ret
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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