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

Not Applicable

• Conditions: Temporomandibular Disorders
• Interventions: Procedure: interocclusal appliance; Procedure: Complete denture rehabilitation; Procedure: Relining of the complete dentures

• Registration Number: NCT02015585
• Lead Sponsor: Federal University of Pelotas

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Primary Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-05
• Last Update Posted: 2017-04-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interocclusal appliance	interocclusal appliance	Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Only Rehabilitation	Complete denture rehabilitation	Patients will be treated with a complete denture without any kind of previous intervention
Interocclusal appliance	Complete denture rehabilitation	Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Relining complete denture base	Complete denture rehabilitation	Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.
Relining complete denture base	Relining of the complete dentures	Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from baseline in the extension of the mandibular movements up to 6 months.	30 days after randomization; and 30 days after the final prosthetic rehabilitation	The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.

Trial Locations

Locations (1)

School of Dentistry, Federal University of Pelotas; 🇧🇷 Pelotas, Rio Grande do Sul, Brazil