Clinical Trial: Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.
Brief Summary: 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
Detailed Summary:
Sponsor: Federal University of Pelotas
Current Primary Outcome: Change from baseline of the occlusal vertical dimension after treatment at 6 months [ Time Frame: 30 days after randomization; and 30 days after final prosthetic rehabilitation ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Change from baseline in the extension of the mandibular movements up to 6 months. [ Time Frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation ]
Original Secondary Outcome: Same as current
Information By: Federal University of Pelotas
Dates:
Date Received: September 13, 2013
Date Started: August 2013
Date Completion: December 2017
Last Updated: April 5, 2017
Last Verified: April 2017
