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

Temporomandibular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02015585
• Other study ID #: PPGO0014
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2013
• Last updated: April 5, 2017
• Start date: August 2013
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• interocclusal appliance
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
• 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.
• Complete denture rehabilitation
All patients will be rehabilitated with new complete dentures in the study

Locations

Country	Name	City	State
Brazil	School of Dentistry, Federal University of Pelotas	Pelotas	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in the condyle-fossa relation up to six months	The condyle-fossa relation will be measured by cone-bean computed tomographic scan.	30 days after randomization; and 30 days after the final prosthetic rehabilitation
Primary	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	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