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临床试验/NCT05264480
NCT05264480已完成不适用

A Novel Periodontally Accelerated Osteogenic Orthodontics (PAOO) in the Prevention of Buccal Bone Dehiscence in Patients Receiving Orthodontic Therapy- a Randomized Controlled Clinical Trial

Semmelweis University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Speed of OTM

研究概览

简要总结

The aim of this study is to evaluate in a prospective, randomized, controlled clinical trail the effectiveness of preorthodontic piezotomy combined with a buccal bone augmentation (in other name periodontlly accelerated osteogenic orthodontics: PAOO)in the prevention of gingival recession, and in the acceleration of orthodontic tooth movement (OTM).

详细描述

Patients presenting teeth crowding in mandibulary or maxillary front area, without ongoing periodontal disease, who require OTM with incisor proclination, are included in the study. Patients are randomly allocated into test and control groups. Individuals in both groups receive before OTM a buccal bone augmentation in order to further increase the bony envelope where to teeth are intended to move. Test subjects receive a selected decorticalistation of the buccal bone with a piezosurgical device (piezotomy), while control patients are augmented without piezotomy. 1 week postsurgical multibond orthodontic appliances are bonded to initiate OTM. Teeth movement are measured on cephalometric X-ray images, where an initial and a final (at the end of the nivellation phase) cephalogramm is compared with each other. Buccal bone dimensions are measured on initial and 6th month's postoperatively CBCT images. The investigators' hypothesis is that the buccal bone thickness can be significantly increased, which might prevent the development of gingival recessions. This means, that in both groups the initial and final bone volumes will be comparable without significant difference. It is also hypothesized that the bone changes will not differ significantly between the two groups. However, piezotomy in the test group might have an additional benefit throughout regional acceleratory phenomenon, reducing the duration of OTM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The persons responsible to measure on the cephalogramms and CBCTs are blinded to the study design

入排标准

年龄范围
14 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • tooth crowding exceeding a 5mm lack of space (originating from the discrepancy between the overall mesiodostal length of the teeth and the length of the dental arch present at the time of the evaluation)
  • thin bone morphotype (buccal width of the cortical layer must be under 1mm)
  • incisor proclination in order to eliminate crowding without compensatory extractions.
  • informed consent

排除标准

  • ongoing periodontitis
  • Pregnant women.
  • Participation in another clinical study within 30 days prior to study start.
  • Alcoholism, drug dependency, heavy smoking (>5 cigarettes/day).
  • Known infection with HIV, HBV, or HCV.
  • Patients requiring chemo- or radiotherapy.
  • Previous or current radiotherapy of the head.
  • Uncontrolled or insulin-dependent diabetes mellitus
  • Clinically relevant osteoporosis or systemic disease affecting bone metabolism
  • Clinically relevant cardiovascular disease e.g., decompensated cardiac insufficiency, hemodynamically relevant heart valve defects, or myocardial infarction during the last three months.
  • Clinically relevant blood coagulation disorder.
  • Previous or current treatment with systemic corticosteroids (within 2 months prior to screening visit) of more than 5 mg/day prednisone equivalent.
  • Previous or current therapy with bisphosphonates at least for 30 days within the last 12 months before screening visit

研究组 & 干预措施

Test group

Experimental

Test patients receive bone augmentation and selective decorticalisation (corticotomy) and 1 week postop. OTM.

干预措施: Bone augmentation with minimally invasive corticotomy (piezotomy) (Procedure)

Control group

Active Comparator

Control subjects receive bone augmentation without decorticalisation (corticotomy) and 1 week postop. OTM.

干预措施: Bone augmentation without corticotomy (Procedure)

结局指标

主要结局

Speed of OTM

时间窗: From the date of orthodontic appliance bonding until the date of documented finalization of nivellation phase of OTM registered by the orthodontic specialist (in weeks), assessed up to maximum of 25 weeks.

The angle and distance of the movement of the middle incisor are measure on cephalogramms. The values are divided by the elapsed time frame in order to calculate the speed of OTM.

次要结局

  • Vertical bone level(6 months postoperatively)
  • Horizontal bone levels(6 months postoperatively)

研究者

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

Pal Nagy

Senior Lecturer

Semmelweis University

研究点 (2)

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