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

Primary Purpose

Temporomandibular Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
interocclusal appliance
Relining of the complete dentures
Complete denture rehabilitation
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Dentistry, Federal University of Pelotas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Interocclusal appliance

Relining complete denture base

Only Rehabilitation

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline of the occlusal vertical dimension after treatment at 6 months

Secondary Outcome Measures

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.

Full Information

First Posted
September 13, 2013
Last Updated
April 5, 2017
Sponsor
Federal University of Pelotas
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1. Study Identification

Unique Protocol Identification Number
NCT02015585
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interocclusal appliance
Arm Type
Experimental
Arm Description
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Arm Title
Relining complete denture base
Arm Type
Experimental
Arm Description
Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.
Arm Title
Only Rehabilitation
Arm Type
Active Comparator
Arm Description
Patients will be treated with a complete denture without any kind of previous intervention
Intervention Type
Procedure
Intervention Name(s)
interocclusal appliance
Intervention Description
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Intervention Type
Procedure
Intervention Name(s)
Relining of the complete dentures
Intervention Description
Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
Intervention Type
Procedure
Intervention Name(s)
Complete denture rehabilitation
Intervention Description
All patients will be rehabilitated with new complete dentures in the study
Primary Outcome Measure Information:
Title
Change from baseline of the occlusal vertical dimension after treatment at 6 months
Time Frame
30 days after randomization; and 30 days after final prosthetic rehabilitation
Secondary Outcome Measure Information:
Title
Change from baseline in the extension of the mandibular movements up to 6 months.
Description
The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.
Time Frame
30 days after randomization; and 30 days after the final prosthetic rehabilitation
Other Pre-specified Outcome Measures:
Title
Change from baseline in the condyle-fossa relation up to six months
Description
The condyle-fossa relation will be measured by cone-bean computed tomographic scan.
Time Frame
30 days after randomization; and 30 days after the final prosthetic rehabilitation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
School of Dentistry, Federal University of Pelotas
City
Pelotas
State/Province
Rio Grande do Sul
ZIP/Postal Code
96015-560
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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