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

NCT ID: NCT02015585

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Temporomandibular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Interocclusal appliance

Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.

Group Type: EXPERIMENTAL

interocclusal appliance

Intervention Type: PROCEDURE

Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.

Complete denture rehabilitation

Intervention Type: PROCEDURE

All patients will be rehabilitated with new complete dentures in the study

Relining complete denture base

Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.

Group Type: EXPERIMENTAL

Relining of the complete dentures

Intervention Type: PROCEDURE

Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.

Complete denture rehabilitation

Intervention Type: PROCEDURE

All patients will be rehabilitated with new complete dentures in the study

Only Rehabilitation

Patients will be treated with a complete denture without any kind of previous intervention

Group Type: ACTIVE_COMPARATOR

Complete denture rehabilitation

Intervention Type: PROCEDURE

All patients will be rehabilitated with new complete dentures in the study

Interventions

interocclusal appliance

Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.

Intervention Type: PROCEDURE

Relining of the complete dentures

Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.

Intervention Type: PROCEDURE

Complete denture rehabilitation

All patients will be rehabilitated with new complete dentures in the study

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Pelotas

OTHER

Sponsor Role: lead

Responsible Party

Maximiliano Sergio Cenci

Clinical Trials Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dentistry, Federal University of Pelotas

Pelotas, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

PPGO0014

Identifier Type: -

Identifier Source: org_study_id