denture: Comparison of Lingualized and Full Bilaterally Balanced Articulation
Sponsor
Nihon University (Other)
Overall Status
Completed
CT.gov ID
NCT00959530
Collaborator
(none)
60
1
2
49
1.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
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
:
Nov 1, 2007
Actual Primary Completion Date
:
Sep 1, 2009
Actual Study Completion Date
:
Dec 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: lingualized complete denture fabricated by lingualized occlusion scheme |
Procedure: lingualized occlusion
occlusal surface arranged by lingualized occlusion
Other Names:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- patient satisfaction on 100mm visual analogue scale [6month]
Secondary Outcome Measures
- treatment cost [6month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Heydecke G, Vogeler M, Wolkewitz M, Türp 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.
- 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.
- 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. Erratum in: J Prosthet Dent. 2007 Jul;98(1):16.
- Sutton AF, Worthington HV, McCord JF. RCT comparing posterior occlusal forms for complete dentures. J Dent Res. 2007 Jul;86(7):651-5.
Responsible Party:
Yasuhiko Kawai,
Professor,
Nihon University
ClinicalTrials.gov Identifier:
NCT00959530
Other Study ID Numbers:
- 07-014
First Posted:
Aug 14, 2009
Last Update Posted:
Mar 29, 2017
Last Verified:
Mar 1, 2017
Keywords provided by Yasuhiko Kawai,
Professor,
Nihon University
Additional relevant MeSH terms: