- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02289443
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
Study Overview
Detailed Description
Study design A 10-year follow-up study of a randomized controlled clinical trial (RCT) carried out from 2001 to 2003, including assessment of patient satisfaction, denture repair/replacement and OHRQoL. Data will be gathered through telephone interviews. Since the contacts were last used a decade ago, the phone number may have been changed, but we will make every effort to find new numbers for any participant those contact information is no longer valid .
Subjects 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.
Interviews and blinding Potential subjects will be told that we are investigating conditions of their dentures 10-years after the delivery and that we will ask general questions, as well as for their ratings of satisfaction and OHRQoL regarding their dentures. After this, the subjects will be asked whether they are willing to respond to the interviews. If they agree, the interviewer will ask the questions according to a flow chart (Appendix 1a, b). The subjects will not be told to which group they had been assigned, and a blinded research assistant will carry out the interviews and data gathering. The research assistant worked with these participants during the active study 10 years before. Patients will be excluded if they cannot respond properly to the questions.
Questionnaires Data will be gathered by four questionnaires: socio-demographic (Q1: Appendix 2), denture history/oral health (Q2: Appendix 3), general and related satisfaction outcomes by answering VAS (visual analog scale) scores out of 100 (Q3: Appendix 4), and OHQOL measures (OHIP-EDENT) 12, 13 (Q4: Appendix 5).
Analysis Denture history The difference in number of people who keep and use the dentures at 10 years will be calculated in percentages. A Chi-squared test will be employed for the statistical analyses. Finally, the prevalence of problems associated with the dentures will be calculated.
Satisfaction The differences between the treatment groups in their general satisfaction ratings on 100mm VAS after the prostheses are worn for 10 years. A two-sample independent t-test will be employed. VAS items of comfort, stability, esthetics, retention, function and ease of cleaning are also included. These will be compared between the groups using t-tests.
OHRQoL OHIP-EDENT consists of 19 statements and responses varying from 0 to 4 on a Likert scale. The possible range between 0 and 76 will be derived individually and compared between the two groups. A two-sample independent t-test will be employed.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Who can be contact with telephone call and accept the interview
Exclusion Criteria:
- The line is closed, no response, who have deceased.
- Refused to answer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Simplified
Complete denture fabricated by simple way than the textbook traditional method.
|
Comparison of different procedures
|
Traditional
Complete denture fabricated by textbook discribed traditional method.
|
Comparison of different procedures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient satisfaction
Time Frame: 10years
|
10years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Denture repair/replacement
Time Frame: 10years
|
10years
|
Oral Health related Quality of Life
Time Frame: 10years
|
10years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- Kawai 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.
- Kawai 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A09-E71-12B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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