Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation
Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 13, 2013
CompletedFirst Posted
Study publicly available on registry
December 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 6, 2017
April 1, 2017
2.3 years
September 13, 2013
April 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Other Outcomes (1)
Change from baseline in the condyle-fossa relation up to six months
30 days after randomization; and 30 days after the final prosthetic rehabilitation
Study Arms (3)
Interocclusal appliance
EXPERIMENTALPatients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Relining complete denture base
EXPERIMENTALPatients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.
Only Rehabilitation
ACTIVE COMPARATORPatients will be treated with a complete denture without any kind of previous intervention
Interventions
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
All patients will be rehabilitated with new complete dentures in the study
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dentistry, Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015-560, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Trials Coordinator
Study Record Dates
First Submitted
September 13, 2013
First Posted
December 19, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2017
Last Updated
April 6, 2017
Record last verified: 2017-04