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

Study Overview
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Brief Summary
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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.

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

Conditions
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Temporomandibular Disorders

Intervention / Treatment
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* Procedure: interocclusal appliance
* Procedure: Relining of the complete dentures
* Procedure: Complete denture rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interocclusal appliance<br>Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures. | Procedure: interocclusal appliance<br>* Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.<br>Procedure: Complete denture rehabilitation<br>* All patients will be rehabilitated with new complete dentures in the study<br>|
| Experimental: Relining complete denture base<br>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<br>* Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.<br>Procedure: Complete denture rehabilitation<br>* All patients will be rehabilitated with new complete dentures in the study<br>|
| Active Comparator: Only Rehabilitation<br>Patients will be treated with a complete denture without any kind of previous intervention | Procedure: Complete denture rehabilitation<br>* All patients will be rehabilitated with new complete dentures in the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the occlusal vertical dimension after treatment at 6 months |  | 30 days after randomization; and 30 days after final prosthetic rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days after randomization; and 30 days after the final prosthetic rehabilitation |