EdentulousNCT02289443
a 10-year Follow-up Study of a Randomized Clinical Trial
An observational study of Edentulous, run by Nihon University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous
- What is being tested?
- complete denture
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Who can be contact with telephone call and accept the interview
Who cannot join
- The line is closed, no response, who have deceased.
- Refused to answer
About this study
Official title: Comparison of Two Different Procedures Fabrication of Conventional Complete Dentures: a 10-year Follow-up Study of a Randomized Clinical Trial
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.
Read the 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have been changed, but we will make every effort to find new numbers for any participant those contact information is no longer valid .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.
- Conditions
- Edentulous
- Being tested
- complete denture
- Keywords
- complete dentures, 10-year follow-up, patient report outcomes
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete dentureOther
Comparison of different procedures
| Study group | Role | What they receive |
|---|---|---|
| Simplified | Complete denture fabricated by simple way than the textbook traditional method. Receives: Other: complete denture | |
| Traditional | Complete denture fabricated by textbook discribed traditional method. Receives: Other: complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Measured: 10years
Secondary outcomes (2)
Denture repair/replacement
Measured: 10years
Oral Health related Quality of Life
Measured: 10years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Principal investigator, Yasuhiko Kawai, Nihon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289443
- Sponsor's protocol ID
- A09-E71-12B
- Status last verified
- Mar 2017
- First submitted
- 9 Nov 2014
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 20723019Kawai 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.
PubMed 16139697Kawai 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.
PubMed 29758255
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Procedures Fabrication of Conventional Complete Dentures: a 10-year Follow-up Study of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02289443
- Acronym / sponsor ID
- A09-E71-12B
- Conditions
- Edentulous
- Keywords
- complete dentures, 10-year follow-up, patient report outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simplified | – | Other: complete dentureComplete denture fabricated by simple way than the textbook traditional method. |
| Traditional | – | Other: complete dentureComplete denture fabricated by textbook discribed traditional method. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Who can be contact with telephone call and accept the interview
Key exclusion criteria (2 listed)
- The line is closed, no response, who have deceased.
- Refused to answer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complete dentureComparison of different procedures | Other | Simplified, Traditional |
Primary outcome
Patient satisfaction
Time frame: 10years
2 secondary outcomes
Denture repair/replacement
Time frame: 10years
Oral Health related Quality of Life
Time frame: 10years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Results publication: PubMed 20723019Kawai 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.
- Results publication: PubMed 16139697Kawai 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.
- Derived from this study: PubMed 29758255Kawai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous, run by Nihon University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 10years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02289443, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.