Comparison of Lingualized and Full Bilaterally Balanced Articulation (denture)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yasuhiko Kawai, Nihon Univerity

ClinicalTrials.gov Identifier:

NCT00959530

First received: August 13, 2009

Last updated: October 7, 2012

Last verified: October 2012

History of Changes

Purpose

The purpose of this study is to find the difference between patient satisfaction, masticatory performance and cost between two occlusal schemes for complete denture prosthodontics.

Condition	Intervention	Phase
Jaw, Edentulous	Procedure: lingualized occlusion Procedure: Full Bilaterally Balanced Articulation	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Randomized Clinical Trial Comparing Lingualized and Full Bilaterally Balanced Articulation for Complete Dentures

Resource links provided by NLM:

MedlinePlus related topics: Dentures

U.S. FDA Resources

Further study details as provided by Nihon University:

Primary Outcome Measures:

patient satisfaction on 100mm visual analogue scale [ Time Frame: 6month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

treatment cost [ Time Frame: 6month ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	November 2007
Study Completion Date:	December 2011
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lingualized complete denture fabricated by lingualized occlusion scheme	Procedure: lingualized occlusion occlusal surface arranged by lingualized occlusion Other Name: e-ha artificial teeth, shofu porcelain teeth
Placebo Comparator: Full Bilaterally Balanced Articulation complete denture fabricated by Full Bilaterally Balanced Articulation scheme	Procedure: Full Bilaterally Balanced Articulation occlusal surface arranged by Full Bilaterally Balanced Articulation Other Name: Shofu Ace Posterior

Detailed Description:

Two occlusal scheme applied to complete denture prosthodontics has been compared in RCT. This will have clinical benefit for deciding which occlusal scheme is better according to patient conditions. It will also have impact on dental educational curriculum.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

edentulous both maxilla and mandible, asking for new denture fabrication

Exclusion Criteria:

psychiatric problem
those who have difficulty answering the questionnaire
oral cancer
radiation experience

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959530

Locations

Japan
Nihon University Hospital
Matsudo, Chiba, Japan, 2718587

Sponsors and Collaborators

Nihon University

Investigators

Principal Investigator:	Yasuhiko Kawai, DDS MMedSc	Nihon University
Principal Investigator:	Yuichi Matsumaru, DDS	Nihon University

More Information

Publications:

Heydecke G, Vogeler M, Wolkewitz M, Türp JC, Strub JR. Simplified versus comprehensive fabrication of complete dentures: patient ratings of denture satisfaction from a randomized crossover trial. Quintessence Int. 2008 Feb;39(2):107-16.

Sutton AF, Worthington HV, McCord JF. RCT comparing posterior occlusal forms for complete dentures. J Dent Res. 2007 Jul;86(7):651-5.

Sutton AF, McCord JF. A randomized clinical trial comparing anatomic, lingualized, and zero-degree posterior occlusal forms for complete dentures. J Prosthet Dent. 2007 May;97(5):292-8. Erratum in: J Prosthet Dent. 2007 Jul;98(1):16.

Kimoto S, Gunji A, Yamakawa A, Ajiro H, Kanno K, Shinomiya M, Kawai Y, Kawara M, Kobayashi K. Prospective clinical trial comparing lingualized occlusion to bilateral balanced occlusion in complete dentures: a pilot study. Int J Prosthodont. 2006 Jan-Feb;19(1):103-9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Matsumaru Y. Influence of mandibular residual ridge resorption on objective masticatory measures of lingualized and fully bilateral balanced denture articulation. J Prosthodont Res. 2010 Jul;54(3):112-8. Epub 2010 Jan 19.

Responsible Party:	Yasuhiko Kawai, Professor, Nihon Univerity
ClinicalTrials.gov Identifier:	NCT00959530 History of Changes
Other Study ID Numbers:	07-014
Study First Received:	August 13, 2009
Last Updated:	October 7, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Nihon University:

complete dentures
patient satisfaction
treatment cost

Additional relevant MeSH terms:

Jaw, Edentulous
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases

Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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