Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420536
• Other study ID #: Unesp-PT-001
• Secondary ID: 2008/07183-5
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

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.

Locations

Country	Name	City	State
Brazil	Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)	Araraquara	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External 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)