Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

Study Overview
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Brief Summary
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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
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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]

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

Conditions
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Edentulous Mouth, Edentulous Jaw

Intervention / Treatment
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* Procedure: Occlusal scheme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canine Guidance<br>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<br>* 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.<br>* Other names: Denture oclusion;|
| Sham Comparator: Bilateral Balanced Occlusion<br>Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions | Procedure: Occlusal scheme<br>* 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.<br>* Other names: Denture oclusion;|

What is the study measuring?
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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 -- (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.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.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 | 
| 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 -- (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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Satisfaction, Bilateral Balanced Occlusion, Canine Guidance, Complete Denture, Denture Retention, Dental Occlusion, Edentulous, Edentulism, Mandibular movement, Mastication, Patient Acceptance of Health Care