Tooth-lossNCT02117856
Complete Lower Dentures on 1 or 2 Implants
A study testing 1 implant placed surgically in the mandibular midline, 2 implants placed surgically in the mandibular canine sites and Soft reline (Coe Comfort) of the existing complete lower denture in people with Tooth-loss and Edentulous Mouth, run by University of British Columbia at 1 site in Canada.
Trial summary
This study is a randomized clinical trial to compare patient satisfaction and prosthetic outcomes with lower dentures retained by one or two implants. The investigators long-term objective is to establish evidence of the cost-effectiveness of a single implant intervention for improving tolerance to complete dentures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth-loss, Edentulous Mouth, Complete Denture
- What is being tested?
- 1 implant placed surgically in the mandibular midline, 2 implants placed surgically in the mandibular canine sites and Soft reline (Coe Comfort) of the existing complete lower denture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2002to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- functional in English or accompanied by a responsible adult who can provide translation services
- able to consent to, and participate in, the treatment provided
- available for the duration of the study
- edentulous and with at least six month's experience with conventional complete dentures
- currently wearing conventional complete dentures that are esthetically satisfactory to the patient and technically acceptable in the judgment of the study prosthodontist(s)
- medically/psychologically suitable for implant surgery in the judgment of the study dentists
Who cannot join
- insufficient alveolar bone height for implant(s) (< 10 mm)
- history of head and neck radiation
- systemic or neurological disease, including: American Society of Anesthesiologists (ASA) Class 3 with recently diagnosed severe systemic disease, e.g. recent (within 6 months) myocardial infarction or stroke; risks associated with bacteraemia, e.g. immune compromise, steroids, in-dwelling catheters, stents, prosthetic heart valves, etc.; Type 1 diabetes, pituitary and adrenal insufficiency, and untreated hypothyroidism; chronic granulomatous disease, e.g. tuberculosis and sarcoidosis; bone disease, e.g. histiocytosis X, Paget's disease, fibrous dysplasia; history of congenital or acquired uncontrolled bleeding, e.g. coumadin
- previous oral implant treatment
- need for additional pre-prosthetic surgery
- need for new complete dentures
- medically/psychologically unsuitable for surgery in the opinion of the study dentists
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Oral Health Sciences, University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: A Randomized Clinical Trial Comparing Patient Satisfaction and Prosthetic Outcomes With Mandibular Implant Overdentures Retained by 1 or 2 Implants
This study is a randomized clinical trial to compare patient satisfaction and prosthetic outcomes with lower dentures retained by one or two implants. The investigators long-term objective is to establish evidence of the cost-effectiveness of a single implant intervention for improving tolerance to complete dentures. The investigators MAIN AIM will be to investigate patient satisfaction between and within groups with mandibular dentures retained by one or two implants over five years, and SECONDARILY to investigate the survival of implants, and the frequency of events to maintain the dentures and prosthetic attachments as clinically serviceable. Furthermore, multivariate analysis can assess the prediction of patient satisfaction with implant dentures based on various possible factors including age, health, demography and socioeconomic status, number of implants, and maintenance needs. Patient satisfaction will be measured by means of Visual Analogue Scales (VAS) including a measure of overall satisfaction and various specific aspects of satisfaction such as appearance, stability and comfort of the dentures.
The CENTRAL HYPOTHESIS is that mandibular complete dentures retained by single implants are at least as satisfying to patients over a five years period as those retained by two implants for the same period.
Read more
The SECONDARY HYPOTHESES are that:
- there is no difference over five years between groups in the survival of original implants, or in the number of events for maintenance of the dentures or implant attachments; and ii) using each treatment group as it's own control, there is no change in patient satisfaction with lower dentures retained by either one or two implants during the five year loading period.
- Conditions
- Tooth-loss, Edentulous Mouth, Complete Denture, Complete Lower Denture
- Being tested
- 1 implant placed surgically in the mandibular midline, 2 implants placed surgically in the mandibular canine sites, Soft reline (Coe Comfort) of the existing complete lower denture, 2.25mm ball patrix placed on 1 healed implant, 2.25mm ball patrices placed on 2 healed implants
- Keywords
- Implant-Supported Denture, Single-Implant Denture, Patient Satisfaction, Edentulous Mandible, Dental Implants, Standard of Care, Randomized Clinical Trial
- Medical subject headings
- Anodontia, Mouth, Edentulous, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 implant placed surgically in the mandibular midlineProcedure or surgery
Also called Implant is Solid Screw, SLA surface, Straumann Canada
Participants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia.
2 implants placed surgically in the mandibular canine sitesProcedure or surgery
Also called Implants are Solid Screw, SLA surface, Straumann Canada
Participants receive implants bilaterally in the site of the mandibular canines using a surgical flap procedure with local anaesthesia.
Soft reline (Coe Comfort) of the existing complete lower dentureProcedure or surgery
Also called Soft reline is Coe Comfort, GC Corporation
Participants receive a soft reline of the existing complete lower denture approximately 10 days after placement of the implant(s).
2.25mm ball patrix placed on 1 healed implantDevice
Also called Patrix is Spherical Stud Retentive Anchor, Straumann Canada
A 2.25mm ball patrix is screwed onto the 1 implant approximately six weeks after placement of the implant.
2.25mm ball patrices placed on 2 healed implantsDevice
Also called Patrix is Spherical Stud Retentive Anchor, Straumann Canada
2.25mm ball patrices are screwed onto the 2 implants approximately six weeks after placement of the implants.
Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower dentureProcedure or surgery
Also called Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada, Matrix is Straumann Gold Matrix, Straumann Canada
Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 1 retentive matrix in the denture-base to retain on the implant.
Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower dentureProcedure or surgery
Also called Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada, Matrix is Straumann Gold Matrix, Straumann Canada
Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 2 retentive matrices in the denture-base to retain on the implants
| Study group | Role | What they receive |
|---|---|---|
| 1 implant | Active comparator | Participants receive the following:
1 implant placed surgically in the mandibular midline; Soft reline of the existing complete lower denture; 2.25mm ball patrix placed on 1 healed implant; and Reline with 1 retentive matrix in the lower denture. Receives: Procedure: 1 implant placed surgically in the mandibular midline; Procedure: Soft reline (Coe Comfort) of the existing complete lower denture; Device: 2.25mm ball patrix placed on 1 healed implant; Procedure: Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower denture |
| 2 implants | Active comparator | Participants receive the following:
2 implants placed surgically in the mandibular canine sites; Soft reline of the existing complete lower denture; 2.25mm ball patrices placed on 2 healed implants; and Reline with 2 retentive matrices in the lower denture. Receives: Procedure: 2 implants placed surgically in the mandibular canine sites; Procedure: Soft reline (Coe Comfort) of the existing complete lower denture; Device: 2.25mm ball patrices placed on 2 healed implants; Procedure: Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessed VAS satisfaction with the mandibular denture
Self-assessed satisfaction is measured on a 10 cm uninterrupted visual analogue scale (VAS) representing a continuum of feelings, with "unsatisfied" at one end and "satisfied" at the other. Each participant makes a global assessment of their satisfaction by marking an X on the line at a point corresponding to their response to the question: "How would you evaluate your 'overall satisfaction' with your lower denture?". A research assistant translates the mark into a number from 0 to 100 by superimposing a template with numbered intervals from 0 to 100 mm.
Measured: Annually during 10 years after attaching the mandibular implant denture
Secondary outcomes (7)
Change in self-assessed VAS satisfaction with the mandibular denture
Self-assessed satisfaction is measured on a 10 cm uninterrupted visual analogue scale (VAS) representing a continuum of feelings, with "unsatisfied" at one end and "satisfied" at the other. Each participant makes a global assessment of their satisfaction by marking an X on the line at a point corresponding to their response to the question: "How would you evaluate your 'overall satisfaction' with your lower denture?". A research assistant translates the mark into a number from 0 to 100 by superimposing a template with numbered intervals from 0 to 100 mm.
Measured: From baseline (before implants) to each annual followup for 10 years after attaching the mandibular implant denture
Cumulative Implant Survival
Cumulative implant survival was judged by the time to the presence of clinical mobility, pain or suppuration associated with the original mandibular implants.
Measured: During the 10 years after attaching the mandibular implant denture
The frequency of prosthetic maintenance events for the mandibular implant overdenture
The frequency of prosthetic maintenance treatment events for the mandibular denture including adjustment, reattachment, or replacement of implant attachment components, and denture base fractures, relining or rebasing, and denture replacement with a new lower denture.
Measured: During 10 years after attaching the mandibular implant denture
Time to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention
This is the total professional chair-time recorded to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention.
Measured: From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement
Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention
This is the total cost of components and professional and dental laboratory fees to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention.
Measured: From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement
Time to provide prosthetic maintenance treatment for the mandibular implant overdenture
This is the total professional chair-time recorded to provide prosthetic maintenance treatment for the maxillary denture and the mandibular implant overdenture including contour adjustments, and adjustment, reattachment, or replacement of implant attachment components, and denture repairs, relining or rebasing.
Measured: During 1 year after attachment of the mandibular implant denture
Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture
This is the total cost of components and professional and dental laboratory fees to provide prosthetic maintenance treatment for the maxillary denture and the mandibular implant overdenture including contour adjustments, and adjustment, reattachment, or replacement of implant attachment components, and denture repairs, relining or rebasing.
Measured: During 1 year after attachment of the mandibular implant denture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startNov 2002
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth-lossStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland, Canadian Institutes of Health Research (CIHR), Straumann Canada Ltd.
- Responsible party
- Principal investigator, Ross Bryant, University of British Columbia
- Investigators
- Stephen R. Bryant, DDS, PhD, Principal investigator, University of British ColumbiaMichael I. MacEntee, LDS, PhD, Study director, University of British ColumbiaJoanne N. Walton, DDS, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117856
- Sponsor's protocol ID
- H02-70082
- Status last verified
- Jun 2019
- First submitted
- 8 Apr 2014
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Walton JN, MacEntee MI. Choosing or refusing oral implants: a prospective study of edentulous volunteers for a clinical trial. Int J Prosthodont. 2005 Nov-Dec;18(6):483-8.
PubMed 16335167Walton JN, MacEntee MI. Screening and enrolling subjects in a randomized clinical trial involving implant dentures. Int J Prosthodont. 2008 May-Jun;21(3):210-4.
PubMed 18548957Walton JN, Glick N, Macentee MI. A randomized clinical trial comparing patient satisfaction and prosthetic outcomes with mandibular overdentures retained by one or two implants. Int J Prosthodont. 2009 Jul-Aug;22(4):331-9.
PubMed 19639067Gonda T, Maeda Y, Walton JN, MacEntee MI. Fracture incidence in mandibular overdentures retained by one or two implants. J Prosthet Dent. 2010 Mar;103(3):178-81. doi: 10.1016/S0022-3913(10)60026-1.
PubMed 20188240Bryant SR, Walton JN, MacEntee MI. A 5-year randomized trial to compare 1 or 2 implants for implant overdentures. J Dent Res. 2015 Jan;94(1):36-43. doi: 10.1177/0022034514554224. Epub 2014 Oct 27.
PubMed 25348544
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Comparing Patient Satisfaction and Prosthetic Outcomes With Mandibular Implant Overdentures Retained by 1 or 2 Implants
- ClinicalTrials.gov ID
- NCT02117856
- Acronym / sponsor ID
- H02-70082
- Conditions
- Tooth-loss, Edentulous Mouth, Complete Denture, Complete Lower Denture
- Keywords
- Implant-Supported Denture, Single-Implant Denture, Patient Satisfaction, Edentulous Mandible, Dental Implants, Standard of Care, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland, Canadian Institutes of Health Research (CIHR), Straumann Canada Ltd.
- Study start
- Nov 2002
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Apr 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.
This study is a randomized clinical trial to compare patient satisfaction and prosthetic outcomes with lower dentures retained by one or two implants. The investigators long-term objective is to establish evidence of the cost-effectiveness of a single implant intervention for improving tolerance to complete dentures. The investigators MAIN AIM will be to investigate patient satisfaction between and within groups with mandibular dentures retained by one or two implants over five years, and SECONDARILY to investigate the survival of implants, and the frequency of events to maintain the dentures and prosthetic attachments as clinically serviceable. Furthermore, multivariate analysis can assess the prediction of patient satisfaction with implant dentures based on various possible factors including age, health, demography and socioeconomic status, number of implants, and maintenance needs. Patient satisfaction will be measured by means of Visual Analogue Scales (VAS) including a measure of overall satisfaction and various specific aspects of satisfaction such as appearance, stability and comfort of the dentures.
The CENTRAL HYPOTHESIS is that mandibular complete dentures retained by single implants are at least as satisfying to patients over a five years period as those retained by two implants for the same period.
The SECONDARY HYPOTHESES are that:
- there is no difference over five years between groups in the survival of original implants, or in the number of events for maintenance of the dentures or implant attachments; and ii) using each treatment group as it's own control, there is no change in patient satisfaction with lower dentures retained by either one or two implants during the five year loading period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 implant | Active comparator | Procedure: 1 implant placed surgically in the mandibular midline, Procedure: Soft reline (Coe Comfort) of the existing complete lower denture, Device: 2.25mm ball patrix placed on 1 healed implant, Procedure: Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower dentureParticipants receive the following: 1 implant placed surgically in the mandibular midline; Soft reline of the existing complete lower denture; 2.25mm ball patrix placed on 1 healed implant; and Reline with 1 retentive matrix in the lower denture. |
| 2 implants | Active comparator | Procedure: 2 implants placed surgically in the mandibular canine sites, Procedure: Soft reline (Coe Comfort) of the existing complete lower denture, Device: 2.25mm ball patrices placed on 2 healed implants, Procedure: Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower dentureParticipants receive the following: 2 implants placed surgically in the mandibular canine sites; Soft reline of the existing complete lower denture; 2.25mm ball patrices placed on 2 healed implants; and Reline with 2 retentive matrices in the lower denture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- functional in English or accompanied by a responsible adult who can provide translation services
- able to consent to, and participate in, the treatment provided
- available for the duration of the study
- edentulous and with at least six month's experience with conventional complete dentures
- currently wearing conventional complete dentures that are esthetically satisfactory to the patient and technically acceptable in the judgment of the study prosthodontist(s)
Key exclusion criteria (7 listed)
- insufficient alveolar bone height for implant(s) (< 10 mm)
- history of head and neck radiation
- systemic or neurological disease, including: American Society of Anesthesiologists (ASA) Class 3 with recently diagnosed severe systemic disease, e.g. recent (within 6 months) myocardial infarction or stroke; risks associated with bacteraemia, e.g. immune compromise, steroids, in-dwelling catheters, stents, prosthetic heart valves, etc.; Type 1 diabetes, pituitary and adrenal insufficiency, and untreated hypothyroidism; chronic granulomatous disease, e.g. tuberculosis and sarcoidosis; bone disease, e.g. histiocytosis X, Paget's disease, fibrous dysplasia; history of congenital or acquired uncontrolled bleeding, e.g. coumadin
- previous oral implant treatment
- need for additional pre-prosthetic surgery
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 |
|---|---|---|
| 1 implant placed surgically in the mandibular midlineAlso: Implant is Solid Screw, SLA surface, Straumann CanadaParticipants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia. | Procedure or surgery | 1 implant |
| 2 implants placed surgically in the mandibular canine sitesAlso: Implants are Solid Screw, SLA surface, Straumann CanadaParticipants receive implants bilaterally in the site of the mandibular canines using a surgical flap procedure with local anaesthesia. | Procedure or surgery | 2 implants |
| Soft reline (Coe Comfort) of the existing complete lower dentureAlso: Soft reline is Coe Comfort, GC CorporationParticipants receive a soft reline of the existing complete lower denture approximately 10 days after placement of the implant(s). | Procedure or surgery | 1 implant, 2 implants |
| 2.25mm ball patrix placed on 1 healed implantAlso: Patrix is Spherical Stud Retentive Anchor, Straumann CanadaA 2.25mm ball patrix is screwed onto the 1 implant approximately six weeks after placement of the implant. | Device | 1 implant |
| 2.25mm ball patrices placed on 2 healed implantsAlso: Patrix is Spherical Stud Retentive Anchor, Straumann Canada2.25mm ball patrices are screwed onto the 2 implants approximately six weeks after placement of the implants. | Device | 2 implants |
| Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower dentureAlso: Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada, Matrix is Straumann Gold Matrix, Straumann CanadaParticipants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 1 retentive matrix in the denture-base to retain on the implant. | Procedure or surgery | 1 implant |
| Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower dentureAlso: Reline is Ivoclar acrylic-resin, Ivoclar Vivaent Inc, Canada, Matrix is Straumann Gold Matrix, Straumann CanadaParticipants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 2 retentive matrices in the denture-base to retain on the implants | Procedure or surgery | 2 implants |
Primary outcome
Self-assessed VAS satisfaction with the mandibular denture
Time frame: Annually during 10 years after attaching the mandibular implant denture
Self-assessed satisfaction is measured on a 10 cm uninterrupted visual analogue scale (VAS) representing a continuum of feelings, with "unsatisfied" at one end and "satisfied" at the other. Each participant makes a global assessment of their satisfaction by marking an X on the line at a point corresponding to their response to the question: "How would you evaluate your 'overall satisfaction' with your lower denture?". A research assistant translates the mark into a number from 0 to 100 by superimposing a template with numbered intervals from 0 to 100 mm.
7 secondary outcomes
Change in self-assessed VAS satisfaction with the mandibular denture
Time frame: From baseline (before implants) to each annual followup for 10 years after attaching the mandibular implant denture
Cumulative Implant Survival
Time frame: During the 10 years after attaching the mandibular implant denture
The frequency of prosthetic maintenance events for the mandibular implant overdenture
Time frame: During 10 years after attaching the mandibular implant denture
Time to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention
Time frame: From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement
Costs to provide the initial surgical and prosthetic treatment for the mandibular implant overdenture intervention
Time frame: From baseline (before implants) until attachment of the mandibular implant denture, 6 weeks after implant placement
Time to provide prosthetic maintenance treatment for the mandibular implant overdenture
Time frame: During 1 year after attachment of the mandibular implant denture
Costs to provide prosthetic maintenance treatment for the mandibular implant overdenture
Time frame: During 1 year after attachment of the mandibular implant denture
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Background: PubMed 16335167Walton JN, MacEntee MI. Choosing or refusing oral implants: a prospective study of edentulous volunteers for a clinical trial. Int J Prosthodont. 2005 Nov-Dec;18(6):483-8.
- Background: PubMed 18548957Walton JN, MacEntee MI. Screening and enrolling subjects in a randomized clinical trial involving implant dentures. Int J Prosthodont. 2008 May-Jun;21(3):210-4.
- Results publication: PubMed 19639067Walton JN, Glick N, Macentee MI. A randomized clinical trial comparing patient satisfaction and prosthetic outcomes with mandibular overdentures retained by one or two implants. Int J Prosthodont. 2009 Jul-Aug;22(4):331-9.
- Results publication: PubMed 20188240Gonda T, Maeda Y, Walton JN, MacEntee MI. Fracture incidence in mandibular overdentures retained by one or two implants. J Prosthet Dent. 2010 Mar;103(3):178-81. doi: 10.1016/S0022-3913(10)60026-1.
- Results publication: PubMed 25348544Bryant SR, Walton JN, MacEntee MI. A 5-year randomized trial to compare 1 or 2 implants for implant overdentures. J Dent Res. 2015 Jan;94(1):36-43. doi: 10.1177/0022034514554224. Epub 2014 Oct 27.
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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.
Stephen R. Bryant, DDS, PhD principal investigator
University of British Columbia
Michael I. MacEntee, LDS, PhD study director
University of British Columbia
Joanne N. Walton, DDS study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 implant placed surgically in the mandibular midline, 2 implants placed surgically in the mandibular canine sites and Soft reline (Coe Comfort) of the existing complete lower denture in people with Tooth-loss and Edentulous Mouth, run by University of British Columbia 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 7 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: under way, not looking for participants, as of the sponsor's last update on 19 Jun 2019. 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?
This study is still under way. Results are not available in the source record yet.
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?
Self-assessed VAS satisfaction with the mandibular denture (time frame: Annually during 10 years after attaching the mandibular implant denture). 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 NCT02117856, which also lists 5 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 19 Jun 2019.