Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers

NCT07801768 · tracked via the Priya Life Science Turkey tracker

Sponsor

Marmara University

Phase

Observational

Started

2026-06-15

Last updated

2026-09-24

Condition(s) studied

Orthodontic RetainersTooth Mobility

Investigational drug(s) / intervention(s)

Mobility measurement with Periotest deviceDigital intraoral impression

Mobility measurement with Periotest device: 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 impression: 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 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

35 Years

Healthy volunteers

Accepted

Inclusion Criteria: 1. Patients who have undergone fixed orthodontic treatment at the Department of Orthodontics, Faculty of Dentistry, Marmara University, and whose treatment is nearing completion 2. Patients whose treatment duration is between 2 and 3 years 3. Patients with healthy periodontal tissue (plaque index and gingival index \<1; bleeding on probing \<10 per cent; no clinical attachment loss) 4. Patients aged between 18 and 35 5. Systemically healthy individuals 6. 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 7. Patients for whom impressions cannot be taken to fabricate a retainer 8. Patients without deep bite or a gag reflex who have had a standard retainer fitted Exclusion Criteria: 1. Patients who have undergone orthodontic treatment at another clinic 2. Patients whose treatment lasted longer than 3 years or less than 2 years 3. Patients with a cleft lip and palate or a related syndrome 4. Patients with caries or dental prostheses on the teeth where the retainer is to be bonded 5. Smokers 6. Individuals with missing anterior teeth 7. Individuals taking systemic medication that affects the immune system or may affect periodontal health (e.g. steroids) 8. Pregnant or breastfeeding women

Primary outcome measure(s)

Tooth mobility — 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).

Trial sites (1)

Facility	City	Region	Status
Marmara University	Istanbul	Turkey (Türkiye)

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07801768 on ClinicalTrials.gov ↗ ← All trials in Turkey