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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 September 14, 2014