Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
2026년 8월 30일 업데이트: 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.
연구 개요
상태
모집하지 않고 적극적으로
연구 유형
관찰
등록 (추정된)
80
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Istanbul, 터키 (Türkiye), 34784
- Marmara University
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
확률 샘플
연구 인구
Healthy volunteers whose orthodontic treatment finalized and who waited for taking off braces.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Tooth mobility
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Little irregularity
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 15일
기본 완료 (추정된)
2027년 1월 1일
연구 완료 (추정된)
2027년 3월 1일
연구 등록 날짜
최초 제출
2026년 7월 19일
QC 기준을 충족하는 최초 제출
2026년 8월 30일
처음 게시됨 (실제)
2026년 9월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 30일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .