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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

August 13, 2009
October 7, 2012
November 2007
September 2009   (final data collection date for primary outcome measure)
patient satisfaction on 100mm visual analogue scale [ Time Frame: 6month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959530 on ClinicalTrials.gov Archive Site
treatment cost [ Time Frame: 6month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of Lingualized and Full Bilaterally Balanced Articulation
A Randomized Clinical Trial Comparing Lingualized and Full Bilaterally Balanced Articulation for Complete Dentures

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Jaw, Edentulous
  • Procedure: lingualized occlusion
    occlusal surface arranged by lingualized occlusion
    Other Name: e-ha artificial teeth, shofu porcelain teeth
  • Procedure: Full Bilaterally Balanced Articulation
    occlusal surface arranged by Full Bilaterally Balanced Articulation
    Other Name: Shofu Ace Posterior
  • Experimental: lingualized
    complete denture fabricated by lingualized occlusion scheme
    Intervention: Procedure: lingualized occlusion
  • Placebo Comparator: Full Bilaterally Balanced Articulation
    complete denture fabricated by Full Bilaterally Balanced Articulation scheme
    Intervention: Procedure: Full Bilaterally Balanced Articulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
September 2009   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00959530
07-014
No
Yasuhiko Kawai, Nihon Univerity
Nihon University
Not Provided
Principal Investigator: Yasuhiko Kawai, DDS MMedSc Nihon University
Principal Investigator: Yuichi Matsumaru, DDS Nihon University
Nihon University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP