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临床试验/NCT02015585
NCT02015585Unknown不适用

Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.

Federal University of Pelotas2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Change from baseline of the occlusal vertical dimension after treatment at 6 months

研究概览

简要总结

The edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation. The reline of the denture base and the use of interocclusal appliance prior to definitive rehabilitation could have influence on these functional aspects. However, there are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two treatments in reestablishing these functional aspects. The, aim of this study is to evaluate whether the denture base reline and the use of interocclusal appliance prior to final rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete denture wearers. For this controlled, crossover, randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture wearer over a period of five year, will be selected. The volunteers will be randomly allocated into three subgroups (n= 10) and will receive the following treatments: Control (C)Volunteers will receive new complete denture without any previous intervention in their old complete denture; Relining Denture (RD)Volunteers will be submitted to the relining of the base of the their old complete denture and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to the treatment with interocclusal appliance and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed. Volunteers will be evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical dimension by Willis compass and photographic record. These evaluations will be performed at three periods, T0 baseline; T1 after application of randomized treatment, reline denture and interocclusal appliance); T3 after final rehabilitation. The control group will be evaluated only at periods T0 and T3.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years;
  • Have availability to attend FO / UFPel days predetermined;
  • Agree with the term informed consent, approved by the research ethics committee of FO / UFPel.

排除标准

  • Patients younger than 40 years;
  • Patients who are not users of denture upper and lower;
  • Patients denture wearers during periods of less than five years.

结局指标

主要结局

Change from baseline of the occlusal vertical dimension after treatment at 6 months

时间窗: 30 days after randomization; and 30 days after final prosthetic rehabilitation

次要结局

  • Change from baseline in the extension of the mandibular movements up to 6 months.(30 days after randomization; and 30 days after the final prosthetic rehabilitation)

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximiliano Sergio Cenci

Clinical Trials Coordinator

Federal University of Pelotas

研究点 (2)

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