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Comparison of Lingualized and Full Bilaterally Balanced Articulation (denture)

Primary Purpose

Jaw, Edentulous

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
lingualized occlusion
Full Bilaterally Balanced Articulation
Sponsored by
Nihon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous focused on measuring complete dentures, patient satisfaction, treatment cost

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nihon University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lingualized

Full Bilaterally Balanced Articulation

Arm Description

complete denture fabricated by lingualized occlusion scheme

complete denture fabricated by Full Bilaterally Balanced Articulation scheme

Outcomes

Primary Outcome Measures

patient satisfaction on 100mm visual analogue scale

Secondary Outcome Measures

treatment cost

Full Information

First Posted
August 13, 2009
Last Updated
March 27, 2017
Sponsor
Nihon University
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1. Study Identification

Unique Protocol Identification Number
NCT00959530
Brief Title
Comparison of Lingualized and Full Bilaterally Balanced Articulation
Acronym
denture
Official Title
A Randomized Clinical Trial Comparing Lingualized and Full Bilaterally Balanced Articulation for Complete Dentures
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nihon University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous
Keywords
complete dentures, patient satisfaction, treatment cost

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lingualized
Arm Type
Experimental
Arm Description
complete denture fabricated by lingualized occlusion scheme
Arm Title
Full Bilaterally Balanced Articulation
Arm Type
Placebo Comparator
Arm Description
complete denture fabricated by Full Bilaterally Balanced Articulation scheme
Intervention Type
Procedure
Intervention Name(s)
lingualized occlusion
Other Intervention Name(s)
e-ha artificial teeth, shofu porcelain teeth
Intervention Description
occlusal surface arranged by lingualized occlusion
Intervention Type
Procedure
Intervention Name(s)
Full Bilaterally Balanced Articulation
Other Intervention Name(s)
Shofu Ace Posterior
Intervention Description
occlusal surface arranged by Full Bilaterally Balanced Articulation
Primary Outcome Measure Information:
Title
patient satisfaction on 100mm visual analogue scale
Time Frame
6month
Secondary Outcome Measure Information:
Title
treatment cost
Time Frame
6month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuhiko Kawai, DDS MMedSc
Organizational Affiliation
Nihon University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuichi Matsumaru, DDS
Organizational Affiliation
Nihon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nihon University Hospital
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
2718587
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18560649
Citation
Heydecke G, Vogeler M, Wolkewitz M, Turp JC, Strub JR. Simplified versus comprehensive fabrication of complete dentures: patient ratings of denture satisfaction from a randomized crossover trial. Quintessence Int. 2008 Feb;39(2):107-16.
Results Reference
background
PubMed Identifier
17586713
Citation
Sutton AF, Worthington HV, McCord JF. RCT comparing posterior occlusal forms for complete dentures. J Dent Res. 2007 Jul;86(7):651-5. doi: 10.1177/154405910708600713.
Results Reference
background
PubMed Identifier
17547948
Citation
Sutton AF, McCord JF. A randomized clinical trial comparing anatomic, lingualized, and zero-degree posterior occlusal forms for complete dentures. J Prosthet Dent. 2007 May;97(5):292-8. doi: 10.1016/j.prosdent.2007.03.003. Erratum In: J Prosthet Dent. 2007 Jul;98(1):16.
Results Reference
background
PubMed Identifier
16479769
Citation
Kimoto S, Gunji A, Yamakawa A, Ajiro H, Kanno K, Shinomiya M, Kawai Y, Kawara M, Kobayashi K. Prospective clinical trial comparing lingualized occlusion to bilateral balanced occlusion in complete dentures: a pilot study. Int J Prosthodont. 2006 Jan-Feb;19(1):103-9.
Results Reference
background
PubMed Identifier
20089469
Citation
Matsumaru Y. Influence of mandibular residual ridge resorption on objective masticatory measures of lingualized and fully bilateral balanced denture articulation. J Prosthodont Res. 2010 Jul;54(3):112-8. doi: 10.1016/j.jpor.2009.11.008. Epub 2010 Jan 19.
Results Reference
derived

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Comparison of Lingualized and Full Bilaterally Balanced Articulation

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