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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07801768
Enrollment
80
Registered
2026-09-03
Start date
2026-06-15
Completion date
2027-03-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Retainers, Tooth Mobility

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.

Interventions

DIAGNOSTIC_TESTMobility 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.

DIAGNOSTIC_TESTDigital 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Tooth mobilityFrom enrollment to the end of treatment at 6 monthsTooth 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).

Secondary

MeasureTime frameDescription
Little irregularityFrom enrollment to the end of treatment at 6 monthsAnterior 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.
Arch lengthFrom enrollment to the end of treatment at 6 monthsDental 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026