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Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420536
First Posted: August 19, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 ]
    To be assessed by specific questionnaires


Secondary Outcome Measures:
  • Kinesiographic parameters [ Time Frame: 30 days ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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 ( Other Grant/Funding Number: FAPESP )
First Submitted: August 10, 2011
First Posted: August 19, 2011
Last Update Posted: October 12, 2017
Last Verified: August 2011

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:
Mouth, Edentulous
Jaw, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases