- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07801768
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
30 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
80
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Istanbul, Turquie (Türkiye), 34784
- Marmara University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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
|
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.
|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tooth mobility
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Little irregularity
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 juin 2026
Achèvement primaire (Estimé)
1 janvier 2027
Achèvement de l'étude (Estimé)
1 mars 2027
Dates d'inscription aux études
Première soumission
19 juillet 2026
Première soumission répondant aux critères de contrôle qualité
30 août 2026
Première publication (Réel)
3 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GKAY-ret
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
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