Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

NCT01420536 | Completed Results

• 2 other identifiers: Unesp-PT-0012008/07183-5
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis

  30 days

• Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis

  30 days

• Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis

  30 days

• Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis

  30 days

• Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis

  30 days

Study Arms (2)

Canine Guidance

EXPERIMENTAL

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

Bilateral Balanced Occlusion

SHAM COMPARATOR

Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions

Procedure: Occlusal scheme

Interventions

Occlusal scheme PROCEDURE

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.

Also known as: Dental articulation, Denture oclusion

Bilateral Balanced Occlusion; Canine Guidance

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

Araraquara, São Paulo, 14801-903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22486470 DERIVED

Related 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)

MeSH Terms

Conditions

Mouth, Edentulous; Jaw, Edentulous; Bites and Stings; Patient Acceptance of Health Care; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Jaw Diseases; Musculoskeletal Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

* Losses during follow-up (although only 3 participants declined to continue the research - relatively small number); * Possibility of errors in the kinesiographic assessment (low and equally distributed between the different conditions).

Results Point of Contact

• Title: Prof. Marco Antonio Compagnoni
• Organization: Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

compagno@foar.unesp.br

+55-16-3331-6411

Study Officials

• Raphael F de Souza, DDS, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Marco A Compagnoni, DDS, PhD

  Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 19, 2011
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Locations

BR (1)