Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01420536
First received: August 10, 2011
Last updated: August 18, 2011
Last verified: August 2011
  Purpose

The objective of this study is to compare the canine guidance (CG) and bilateral balanced occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and mandibular complete dentures and, after the intraoral adjustments and adaptation period, will randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.


Condition Intervention
Edentulous Mouth
Edentulous Jaw
Procedure: Occlusal scheme

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Denture satisfaction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    To be assessed by specific questionnaires


Secondary Outcome Measures:
  • Kinesiographic parameters [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA)


Enrollment: 44
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canine Guidance
Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)
Procedure: Occlusal scheme

Before enrollment, all participants will receive conventional complete dentures adjusted according to the bilateral balanced occlusion concept.

Following randomization, canine guidance will be achieved by adding composite resin (Restorative Z100, 3M Brazil, Sumaré, SP, Brazil) on the lingual surface of the maxillary canines. A sham comparator will also employ the addition of composite, but without changing eccentric contacts.

Other Names:
  • Dental articulation
  • Denture oclusion
Sham Comparator: Bilateral Balanced Occlusion
Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Procedure: Occlusal scheme

Before enrollment, all participants will receive conventional complete dentures adjusted according to the bilateral balanced occlusion concept.

Following randomization, canine guidance will be achieved by adding composite resin (Restorative Z100, 3M Brazil, Sumaré, SP, Brazil) on the lingual surface of the maxillary canines. A sham comparator will also employ the addition of composite, but without changing eccentric contacts.

Other Names:
  • Dental articulation
  • Denture oclusion

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients needing new complete dentures
  • Mentally receptiveness
  • Absence of dysfunctional disorders of the masticatory system
  • Normal volume and resilience of residual edentulous ridges
  • Absence of debilitating systemic diseases

Exclusion Criteria:

  • Use of cardiac pacemaker
  • Refusal to participate or inability to provide informed consent
  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: NCT01420536

Locations
Brazil
Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
Araraquara, SP, Brazil, 14801-903
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Raphael F de Souza, DDS, PhD University of Sao Paulo
Study Director: Marco A Compagnoni, DDS, PhD Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
  More Information

Additional Information:
No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raphael Freitas de Souza, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01420536     History of Changes
Other Study ID Numbers: Unesp-PT-001, 2008/07183-5
Study First Received: August 10, 2011
Last Updated: August 18, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
Bilateral Balanced Occlusion
Canine Guidance
Complete Denture
Denture Retention
Dental Occlusion
Edentulous
Edentulism
Mandibular movement
Mastication
Patient Acceptance of Health Care
Patient Satisfaction

Additional relevant MeSH terms:
Jaw, Edentulous
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on July 26, 2014