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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Federal University of Pelotas
Sponsor:
Information provided by (Responsible Party):
Maximiliano Sergio Cenci, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT02015585
First received: September 13, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Temporomandibular Disorders
Procedure: interocclusal appliance
Procedure: Relining of the complete dentures
Procedure: Complete denture rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Federal University of Pelotas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in the extension of the mandibular movements up to 6 months. [ Time Frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation ] [ Designated as safety issue: Yes ]
    The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.


Other Outcome Measures:
  • Change from baseline in the condyle-fossa relation up to six months [ Time Frame: 30 days after randomization; and 30 days after the final prosthetic rehabilitation ] [ Designated as safety issue: Yes ]
    The condyle-fossa relation will be measured by cone-bean computed tomographic scan.


Estimated Enrollment: 30
Study Start Date: August 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interocclusal appliance
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Procedure: interocclusal appliance
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
Procedure: Complete denture rehabilitation
All patients will be rehabilitated with new complete dentures in the study
Experimental: 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.
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.
Procedure: Complete denture rehabilitation
All patients will be rehabilitated with new complete dentures in the study
Active Comparator: Only Rehabilitation
Patients will be treated with a complete denture without any kind of previous intervention
Procedure: Complete denture rehabilitation
All patients will be rehabilitated with new complete dentures in the study

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015585

Contacts
Contact: Noéli Boscato, PhD 55 53 32256741 ext 136 noeliboscato@gmail.com

Locations
Brazil
School of Dentistry, Federal University of Pelotas Recruiting
Pelotas, Rio Grande do Sul, Brazil, 96015-560
Contact: Noéli Boscato, PhD    55 53 32256741 ext 36    noeliboscato@gmail.com   
Principal Investigator: Noeli Boscato, PhD         
Sub-Investigator: Rita de Cássia Almeida, PhD student         
Sponsors and Collaborators
Federal University of Pelotas
  More Information

No publications provided

Responsible Party: Maximiliano Sergio Cenci, Clinical Trials Coordinator, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT02015585     History of Changes
Other Study ID Numbers: PPGO0014
Study First Received: September 13, 2013
Last Updated: December 13, 2013
Health Authority: Brazil: CONEP - Brazilian National Committee for Ethics in Research

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Jaw Diseases
Joint Diseases
Mandibular Diseases
Muscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 27, 2014