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

NCT07801768 | Active Not Recruiting

• 1 other identifier: GKAY-ret
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Retainers; Tooth Mobility

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

• Little irregularity

  From enrollment to the end of treatment at 6 months

• Arch length

  From enrollment to the end of treatment at 6 months

Study Arms (4)

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

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

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

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

Diagnostic Test: Mobility measurement with Periotest device; Diagnostic Test: Digital intraoral impression

Interventions

Mobility measurement with Periotest device DIAGNOSTIC_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.

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 impression DIAGNOSTIC_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.

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

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34784, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 41369988 BACKGROUND

• 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.

  PMID: 34374751 BACKGROUND

• 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.

  PMID: 15747823 BACKGROUND

MeSH Terms

Conditions

Tooth Mobility

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: September 3, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-06

Locations

TU (1)