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临床试验/NCT03755622
NCT03755622Unknown不适用

A Randomized Clinical Trial to Compare the Clinical Application of an Innovated Transpalatal Arch (TPA) Fabricated From 3D Reconstructed Model With Conventionally Constructed TPA.

University of Malaya2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年6月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
52
试验地点
2
主要终点
Change of oral health related quality of life between patients wearing conventional TPA and TPA fabricated from 3D reconstructed model from baseline and at 3 months of wear.

研究概览

简要总结

Trans-palatal Arch or TPA is an intra oral device that is occasionally used in conjunction of orthodontic fixed appliance treatment. It has two main types, the fixed or removable TPA. The purpose of this appliance is to maintain upper jaw's arch width and preventing upper molar teeth from moving forward. It holds the upper molar teeth in their original position so that if any upper teeth are extracted to make room for the others to straighten, the upper molars will not move into the extraction spaces. It comprises of a stainless steel wire with a central semi loop that fits comfortably across but not touching the palate. On each side, it is attached with metal bands around each of the two upper molar teeth.

The construction of TPA requires at least three appointments that take up one to three weeks time. Firstly, an elastic "doughnut" like rubbery separators will be placed between the upper molar teeth using a special tool. Slight tightness is usually felt when the separators are inserted. The whole procedure takes less than a couple of minutes. Patients will be sent away for up to 14 days with the separators in place. For the second appointment, the separators will be removed with dental probe. The correct size metal bands are then selected for the upper molar teeth. Once a correctly fitting band has been chosen, an impression (mould) of the upper teeth with the bands in place will be taken. The impression, together with the bands will be sent to the laboratory for construction of the TPA. Separators will be placed again until patients come back to have TPA fitted.

If the mould of the teeth is scanned and printed out using three dimensions (3D) technology, the number of appointments could be reduced. The second appointment which requires molar bands selection, impression and replacement of separators of upper teeth could be skipped. Molar bands selection can be carried out outside the mouth and straight away sent to the laboratory for TPA construction. All parties involved, patients, clinicians and dental technologists will benefit the innovation by reduction of time spent for TPA related procedure. However, the study that compares innovated TPA from 3D reconstructed models and conventional method has never been done and related similar studies are very scarce.

详细描述

INTRODUCTION

Transpalatal Arch (TPA) has been invented by Dr. Robert Ara Goshgarian, a renowned orthodontist more than 7 decades ago. Throughout the years, various modifications of the design were made for different purposes and to increase its efficacy in achieving the optimum level of anchorage. In 1947, fabrication of Nance Palatal Ach (NPA) pioneered the adjustment of TPA by incorporation of an acrylic button that connects the palatal wire at the highest part of palatal vault. Recent innovations mostly involved adhesions of TPA to mini implants or temporary anchorage devices (TAD) and proven to be time and cost effective to be used in orthodontics. The usage of TPA for space maintenance demonstrated to be more advantagous in term of soft tissue compatibilty and increase in vertical control compared to Nance appliance. The combination of TPA and extraction of deciduos maxillary canines in the late mix dentition has shown to be an acceptable interceptive treatment to prevent maxillary canines palatal impaction. Despite numerous changes and alterations, the versatility of usage has made TPA remained as a useful adjunct in clinical orthodontics until today. However the fabrication of TPA required meticulous clinical steps which started with insertion of elastomeric separators on mesial and distal interproximal surfaces of maxillary permanent first molar teeth. One week later, separators were removed and series of molar bands selection or 'try in' session were carried out to get the correct size that fits the molar teeth. The drawbacks of this action is that, the 'used' molar bands if not properly decontaminated with an enzymatic cleaning and properly sterilized using autoclave, it may constitute a cross-infection hazard. An impression with molar bands in situ were taken and sent to the dental lab for fabrication of TPA followed by re-insertion of separators between the molar teeth. This means that each patient has to bear the discomfort caused by elastomeric separators for at least two weeks time or more. Orthodontists have to spent time for molar bands selection and dental technicians have more workload from pouring of impression until finishing of TPA.

RATIONALE

Patients do not have to undergo twice elastomeric separators placement as reported that among 4 orthodontic treatment procedures carried out,(upper alginate impression, separator placement, band placement and adjustment of arch wire), placement of separator causes a significant bacteraemia. Clinicians could cut down the number of appointments and time could be utilized to see more other cases. Currently there are 7 dental technicians in Paediatric and Orthodontic Department to cater for 10 Orthodontists, 6 Senior Postgraduates and 5 Junior Postgraduates, 1 technician was assigned for Optech management at Balai Ungku Aziz and starting from 2018, all technician will be involved in dental chair maintenance for the whole UM. Heavy workload and other commitments resulted in lack of time to finish all orthodontic cases.

AIM

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Patients who received the Transpalatal Arch (TPA) are not aware whether the appliance is fabricated conventionally or made from 3D reconstructed study model.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and above
  • Requiring premolar extractions
  • Patients do not have previous orthodontic treatment before

排除标准

  • Patient requiring lingual arch, modified TPA, Nance Palatal ArchNon extraction upper arch treatment
  • Patients requiring upper arch expansion
  • Requiring upper first permanent molar extraction
  • Presence of dento-facial anomalies.
  • Patients requiring orthognathic surgery

研究组 & 干预措施

Group C (Conventional)

Active Comparator

Group C consists of patients who receive Transplatal Arch (TPA) fabricated from conventionally made stone working model.

干预措施: Conventional Transpalatal Arch (TPA) (Device)

Group 3D ( Three Dimensional)

Experimental

Group 3D consists of patients who receive Transpalatal Arch (TPA) made from 3D recontructed model.

干预措施: Transpalatal Arch (TPA) fabricated from 3D reconstructed model (Device)

结局指标

主要结局

Change of oral health related quality of life between patients wearing conventional TPA and TPA fabricated from 3D reconstructed model from baseline and at 3 months of wear.

时间窗: 3 months

To compare the level of Oral health related quality of life (OHRQoL) between patients wearing conventional Transpalatal Arch and patients wearing Transpalatal Arch fabricated from three dimensionally reconstructed model in three interval times that is after 1 week (T1) , 1 month (T2) and up to three months post Transpalatal Arch cementation (T3). This is achieved by using validated short version Oral Health Impact Factor 14 (OHIP) questionnaire as the instrument. The minimum score per indivudual is 14 and the maximum score is 70. The lesser the score, the better oral health realted quality of life the patient has.

次要结局

  • Qualitative evaluation of clinicians preferences regarding clinical application between the conventional TPA and TPA fabricated from 3D reconsructed model.(3 months)
  • Change of pain level from baseline to 3 months of wear between patients wearing conventional TPA and TPA fabricated from 3D reconstructed model.(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Wan Nurazreena Wan Hassan

Associate Professor, Lecturer at Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, University of Malaya

University of Malaya

研究点 (2)

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