Comparison of Lingualized and Full Bilaterally Balanced Articulation (denture)

March 27, 2017 updated by: Yasuhiko Kawai, Nihon University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Matsudo, Chiba, Japan, 2718587
        • Nihon University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lingualized
complete denture fabricated by lingualized occlusion scheme
Procedure: lingualized occlusion
occlusal surface arranged by lingualized occlusion
Other Names:
  • 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 Names:
  • Shofu Ace Posterior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient satisfaction on 100mm visual analogue scale
Time Frame: 6month
6month

Secondary Outcome Measures

Outcome Measure
Time Frame
treatment cost
Time Frame: 6month
6month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nihon University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Actual)

March 29, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-014 (Memorial Sloan-Kettering Cancer Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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