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UnknownNCT02015585

Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Federal University of Pelotas · Academic / Other
Sex
All
Age
45 Years
Healthy volunteers
Accepted

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 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREinterocclusal appliancePatients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
PROCEDURERelining of the complete denturesPatients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
PROCEDUREComplete denture rehabilitationAll patients will be rehabilitated with new complete dentures in the study

Timeline

Start date
2013-08-01
Primary completion
2015-12-01
Completion
2017-12-01
First posted
2013-12-19
Last updated
2017-04-06

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT02015585. Inclusion in this directory is not an endorsement.