An interventional study of interocclusal appliance and Relining of the complete dentures in Temporomandibular Disorders, sponsored by Federal University of Pelotas. Status unknown at 1 site in Brazil. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-06.
Sponsored by Federal University of Pelotas · Not applicable, Interventional, and Treatment
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.
609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →Federal University of Pelotas is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Procedure: interocclusal appliance · Procedure: Complete denture rehabilitation
Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.
Procedure: Relining of the complete dentures · Procedure: Complete denture rehabilitation
Patients will be treated with a complete denture without any kind of previous intervention
Procedure: Complete denture rehabilitation
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
All patients will be rehabilitated with new complete dentures in the study
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
Change from baseline in the extension of the mandibular movements up to 6 months.
The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.
Time frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
Change from baseline in the condyle-fossa relation up to six months
The condyle-fossa relation will be measured by cone-bean computed tomographic scan.
Time frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders→
Federal University of Pelotas