Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers

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.

Study Overview

• Status: Completed
• Conditions: Edentulous Jaw; Edentulous Mouth
• Intervention / Treatment: Procedure: Occlusal scheme

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]

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Araraquara, SP, Brazil, 14801-903
      • Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days
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.	30 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Director: Marco A Compagnoni, DDS, PhD, Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

Publications and helpful links

General Publications

• 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.

Helpful Links

• Institutional page of the Araraquara Dental School (research site)
• Institutional page of the Ribeirão Preto Dental School (PI's institution )
• Principal Investigator´s CV (RF Souza)
• Study director´s CV (MA Compagnoni)

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 18, 2011
• First Posted (Estimate): August 19, 2011

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Edentulous; Patient Satisfaction; Patient Acceptance of Health Care; Mastication; Complete Denture; Denture Retention; Edentulism; Mandibular movement; Bilateral Balanced Occlusion; Canine Guidance; Dental Occlusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: Unesp-PT-001; 2008/07183-5 (Other Grant/Funding Number: FAPESP)