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Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

Primary Purpose

Edentulous Mouth, Edentulous Jaw

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Occlusal scheme
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Mouth focused on measuring Bilateral Balanced Occlusion, Canine Guidance, Complete Denture, Denture Retention, Dental Occlusion, Edentulous, Edentulism, Mandibular movement, Mastication, Patient Acceptance of Health Care, Patient Satisfaction

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Canine Guidance

Bilateral Balanced Occlusion

Arm Description

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)

Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions

Outcomes

Primary Outcome Measures

Denture Satisfaction
Assessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.). Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).

Secondary Outcome Measures

Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Full Information

First Posted
August 10, 2011
Last Updated
January 5, 2021
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01420536
Brief Title
Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture
Official Title
A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Reference for published version of the complete study: Paleari AG, Marra J, Rodriguez LS, De Souza RF, Pero AC, De A Mollo Jr F, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures.J Oral Rehabil. 2012 Apr 9. doi: 10.1111/j.1365-2842.2012.02299.x. [Epub ahead of print]

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth, Edentulous Jaw
Keywords
Bilateral Balanced Occlusion, Canine Guidance, Complete Denture, Denture Retention, Dental Occlusion, Edentulous, Edentulism, Mandibular movement, Mastication, Patient Acceptance of Health Care, Patient Satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canine Guidance
Arm Type
Experimental
Arm Description
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)
Arm Title
Bilateral Balanced Occlusion
Arm Type
Sham Comparator
Arm Description
Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Intervention Type
Procedure
Intervention Name(s)
Occlusal scheme
Other Intervention Name(s)
Dental articulation, Denture oclusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Denture Satisfaction
Description
Assessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.). Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days
Title
Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis
Description
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). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael F de Souza, DDS, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco A Compagnoni, DDS, PhD
Organizational Affiliation
Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
Official's Role
Study Director
Facility Information:
Facility Name
Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
City
Araraquara
State/Province
SP
ZIP/Postal Code
14801-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22486470
Citation
Paleari AG, Marra J, Rodriguez LS, de Souza RF, Pero AC, Mollo Fde A Jr, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures. J Oral Rehabil. 2012 Aug;39(8):615-22. doi: 10.1111/j.1365-2842.2012.02299.x. Epub 2012 Apr 9.
Results Reference
derived
Links:
URL
http://www.foar.unesp.br
Description
Institutional page of the Araraquara Dental School (research site)
URL
http://www.forp.usp.br
Description
Institutional page of the Ribeirão Preto Dental School (PI's institution )
URL
http://lattes.cnpq.br/7092555880664311
Description
Principal Investigator´s CV (RF Souza)
URL
http://lattes.cnpq.br/8921196002764597
Description
Study director´s CV (MA Compagnoni)

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Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

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