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Comparison of Lingualized and Full Bilaterally Balanced Articulation (denture)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959530
First Posted: August 14, 2009
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yasuhiko Kawai, Nihon University
  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
Jaw, Edentulous Procedure: lingualized occlusion Procedure: Full Bilaterally Balanced Articulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Yasuhiko Kawai, Nihon University:

Primary Outcome Measures:
  • patient satisfaction on 100mm visual analogue scale [ Time Frame: 6month ]

Secondary Outcome Measures:
  • treatment cost [ Time Frame: 6month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yasuhiko Kawai, Professor, Nihon University
ClinicalTrials.gov Identifier: NCT00959530     History of Changes
Other Study ID Numbers: 07-014
First Submitted: August 13, 2009
First Posted: August 14, 2009
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Yasuhiko Kawai, Nihon University:
complete dentures
patient satisfaction
treatment cost

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases