Clinical trial NCT01420536: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-08-19
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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. \[Epub ahead of print\]

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

Primary outcomes:
measure: Denture Satisfaction
timeFrame: 30 days
Secondary outcomes:
measure: Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis
timeFrame: 30 days
measure: Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis
timeFrame: 30 days
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Raphael F de Souza, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)
name: Marco A Compagnoni, DDS, PhD
role: STUDY_DIRECTOR
References:
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.