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Comparison of Lingualized and Full Bilaterally Balanced Articulation (denture)

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ClinicalTrials.gov Identifier: NCT00959530
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Yasuhiko Kawai, Nihon University

Brief Summary:
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 or disease Intervention/treatment Phase
Jaw, Edentulous Procedure: lingualized occlusion Procedure: Full Bilaterally Balanced Articulation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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

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

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 Posted: August 14, 2009    Key Record Dates
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