a 10-year Follow-up Study of a Randomized Clinical Trial
Comparison of Two Different Procedures Fabrication of Conventional Complete Dentures: a 10-year Follow-up Study of a Randomized Clinical Trial
1 other identifier
observational
104
0 countries
N/A
Brief Summary
In this study, the investigators propose a 10-year follow up study of participants in a randomized clinical trial to compare the oral health-related quality of life (OHRQoL), as well as general and related satisfaction of conventional complete dentures fabricated using two different procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 9, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedMarch 29, 2017
March 1, 2017
1.3 years
November 9, 2014
March 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient satisfaction
10years
Secondary Outcomes (2)
Denture repair/replacement
10years
Oral Health related Quality of Life
10years
Study Arms (2)
Simplified
Complete denture fabricated by simple way than the textbook traditional method.
Traditional
Complete denture fabricated by textbook discribed traditional method.
Interventions
Eligibility Criteria
Patients who participated and completed 6-month follow-ups in the RCT (T group: 50, and S group: 54; total 104 subjects) will be contacted by telephone.
You may qualify if:
- Who can be contact with telephone call and accept the interview
You may not qualify if:
- The line is closed, no response, who have deceased.
- Refused to answer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nihon Universitylead
- McGill Universitycollaborator
Related Publications (3)
Kawai Y, Murakami H, Takanashi Y, Lund JP, Feine JS. Efficient resource use in simplified complete denture fabrication. J Prosthodont. 2010 Oct;19(7):512-6. doi: 10.1111/j.1532-849X.2010.00628.x. Epub 2010 Aug 16.
PMID: 20723019RESULTKawai Y, Murakami H, Shariati B, Klemetti E, Blomfield JV, Billette L, Lund JP, Feine JS. Do traditional techniques produce better conventional complete dentures than simplified techniques? J Dent. 2005 Sep;33(8):659-68. doi: 10.1016/j.jdent.2005.01.005.
PMID: 16139697RESULTKawai Y, Muarakami H, Feine JS. Do traditional techniques produce better conventional complete dentures than simplified techniques? A 10-year follow-up of a randomized clinical trial. J Dent. 2018 Jul;74:30-36. doi: 10.1016/j.jdent.2018.04.027. Epub 2018 May 22.
PMID: 29758255DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 9, 2014
First Posted
November 13, 2014
Study Start
September 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
March 29, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share