- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07801768
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
30. august 2026 opdateret af: 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.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Anslået)
80
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Istanbul, Tyrkiet (Türkiye), 34784
- Marmara University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
|
|
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
|
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
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Tooth mobility
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Little irregularity
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. juni 2026
Primær færdiggørelse (Anslået)
1. januar 2027
Studieafslutning (Anslået)
1. marts 2027
Datoer for studieregistrering
Først indsendt
19. juli 2026
Først indsendt, der opfyldte QC-kriterier
30. august 2026
Først opslået (Faktiske)
3. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GKAY-ret
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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