Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
30. August 2026 aktualisiert von: 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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
80
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Istanbul, Türkei (türkiye), 34784
- Marmara University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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
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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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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.
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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
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Tooth mobility
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Little irregularity
Zeitfenster: From enrollment to the end of treatment at 6 months
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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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Juni 2026
Primärer Abschluss (Geschätzt)
1. Januar 2027
Studienabschluss (Geschätzt)
1. März 2027
Studienanmeldedaten
Zuerst eingereicht
19. Juli 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. August 2026
Zuerst gepostet (Tatsächlich)
3. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
30. August 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- GKAY-ret
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UNENTSCHIEDEN
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