Clinical trial NCT02015585: Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation
Official title: Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Temporomandibular Disorders
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from baseline of the occlusal vertical dimension after treatment at 6 months
timeFrame: 30 days after randomization; and 30 days after final prosthetic rehabilitation
Secondary outcomes:
measure: Change from baseline in the extension of the mandibular movements up to 6 months.
timeFrame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
Other outcomes:
measure: Change from baseline in the condyle-fossa relation up to six months
timeFrame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
Locations:
city: Pelotas
country: Brazil
facility: School of Dentistry, Federal University of Pelotas
state: Rio Grande do Sul
Study officials:
References: