Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

Not Applicable

Completed

• Conditions: Edentulous Jaw; Edentulous Mouth
• Interventions: Procedure: Occlusal scheme

• Registration Number: NCT01420536
• Lead Sponsor: University of Sao Paulo

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. \[Epub ahead of print\]

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Results First Submitted: 2012-06-27
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Results First Posted: 2021-01-26
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bilateral Balanced Occlusion	Occlusal scheme	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Canine Guidance	Occlusal scheme	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)

Primary Outcome Measures

Name	Time	Method
Denture Satisfaction	30 days	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

Name	Time	Method
Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis	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).; 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	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).; 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	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).; 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	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).; 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	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).; 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.a) Maximum Mouth Opening, Vertical Axis	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).; 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	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).; 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	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).; 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	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).; 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	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).; 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	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).; 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	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).; 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.

Trial Locations

Locations (1)

Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University); 🇧🇷 Araraquara, SP, Brazil