Complete EdentulismNCT01566227
Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
A study testing Questionnaire in people with Complete Edentulism, run by University of Manitoba at 1 site in Canada.
Trial summary
This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Apr 2016
- Phase
- Interventional
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures)
- Adult age (25 plus) male or female
- Stable medical health
- Ability to participate in the study for at least 3-4 years
- Able to understand and respond to surveys used in the study
- Adequate amount of bone in the mandible to receive 3 implants.
Who cannot join
- history of drug and alcohol abuse, excessive smoking (more than 1 pack/day)
- surgical limitations:
- uncontrolled systemic disease: diabetes, etc.. that may compromised healing
- irradiated surgical site
- inadequate bone height and width (re: implant size)
- inability to undergo minor oral surgery because of health or personal reasons
- psychological and handicapped conditions that may hinder 4-year involvement (physical handicap conditions)
- Severe TMDs related to joint pathology
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba, Faculty of Dentistry
Winnipeg, Manitoba, R3E 0W2
Reynaldo Todescan, DDS, 204-7893782, Reynaldo_Todescan@umanitoba.ca
Igor Pesun, DDS, 204-7893516, pesun@cc.umanitoba.ca
About this study
This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.
Read the detailed description
The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.
- Conditions
- Complete Edentulism
- Being tested
- Questionnaire
- Keywords
- overdenture, implant, edentulism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Also called Satisfaction survey, questionnaire for patient satisfaction
3 surveys with 10 questions each: one before, during and after treatment
| Study group | Role | What they receive |
|---|---|---|
| number of implants | Experimental | number of implants (1,2 or 3) used to retained an overdenture Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction survey (questionnaires)
Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.
Measured: every 6 months up to three years
Secondary outcomes (2)
Radiographs
Assess crestal bone level around the implants.
Measured: every 6 months up to three years
Wear of 1 vs 2 vs 3 GPS retention components on complete dentures.
The force required to remove the female retentive componenets from the male component will be compaired between one vs two vs three retentive components.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IPesun (1), University of Manitoba
- Investigators
- Igor Pesun, DDS, Principal investigator, Univ. of Manitoba, Faculty of DentistryReynaldo Todescan, DDS., Study director, Univ of Manitoba, Faculty of DentistryMike Barczac, DDS, Study chair, Univ of Manitoba, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566227
- Sponsor's protocol ID
- B2012:012
- Status last verified
- Mar 2012
- First submitted
- 20 Feb 2012
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
- ClinicalTrials.gov ID
- NCT01566227
- Acronym / sponsor ID
- B2012:012
- Conditions
- Complete Edentulism
- Keywords
- overdenture, implant, edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 29 Mar 2012 (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.
This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.
Detailed description
The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| number of implants | Experimental | Other: Questionnairenumber of implants (1,2 or 3) used to retained an overdenture |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures)
- Adult age (25 plus) male or female
- Stable medical health
- Ability to participate in the study for at least 3-4 years
- Able to understand and respond to surveys used in the study
Key exclusion criteria (8 listed)
- history of drug and alcohol abuse, excessive smoking (more than 1 pack/day)
- surgical limitations:
- uncontrolled systemic disease: diabetes, etc.. that may compromised healing
- irradiated surgical site
- inadequate bone height and width (re: implant size)
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 |
|---|---|---|
| QuestionnaireAlso: Satisfaction survey, questionnaire for patient satisfaction3 surveys with 10 questions each: one before, during and after treatment | Other | number of implants |
Primary outcome
Patient Satisfaction survey (questionnaires)
Time frame: every 6 months up to three years
Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.
2 secondary outcomes
Radiographs
Time frame: every 6 months up to three years
Wear of 1 vs 2 vs 3 GPS retention components on complete dentures.
Time frame: baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
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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.
Igor Pesun, DDS principal investigator
Univ. of Manitoba, Faculty of Dentistry
Reynaldo Todescan, DDS. study director
Univ of Manitoba, Faculty of Dentistry
Mike Barczac, DDS study chair
Univ of Manitoba, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire in people with Complete Edentulism, run by University of Manitoba at 1 site in Canada.
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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reynaldo Todescan, Dr (204-7893782, Reynaldo_Todescan@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction survey (questionnaires) (time frame: every 6 months up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2012.