EdentulousNCT01421849
Mandibular Single Implant Overdenture: a Prospective Clinical Trial
A study testing Denture implantation in people with Edentulous, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture. In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture. Read more about this study
- Who is it for?
- Ages 70 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous
- What is being tested?
- Denture implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2011to Dec 2015
- 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 70 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Edentulous residents of nursing homes treated in the mobile dental unit 'Gerodent'.
- They have to be willing to commit to 1.5 year of participation in the study.
- They have to be edentulous for at least one year before starting the implant procedure.
Who cannot join
- Medical conditions contraindicating implant surgery (unregulated diabetes type II, bisphosphonates)
- History of radiotherapy in the head and neck region
- Insufficient bone for an implant of at least 10 mm length and 4 mm diameter
- Previously treated with dental implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial
Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture.
In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture.
Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.
- Conditions
- Edentulous
- Being tested
- Denture implantation
- Keywords
- single implant denture, Elderly with an unstable mandibular denture
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denture implantationProcedure or surgery
In a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture.
Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments.
The total duration of the study will be 12 to 18 months.
| Study group | Role | What they receive |
|---|---|---|
| Elderly with an unstable mandibular denture. | Experimental | Not described Receives: Procedure: Denture implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction after insertion of the new complete dentures.
This will be measured by a questionnaire with 20 items.
Measured: 1 week after insertion of the new complete dentures.
Patient satisfaction after insertion of the complete dentures.
This will be measured by a questionnaire with 20 items.
Measured: 8 weeks after insertion of the complete dentures.
Patient satisfaction post-surgical.
This will be measured by a questionnaire with 20 items.
Measured: 1 week post-surgical.
Patient satisfaction after surgical procedure, functional loading.
This will be measured by a questionnaire with 20 items.
Measured: 6-8 weeks after surgical procedure.
Patient satisfaction after loading the implant.
This will be measured by a questionnaire with 20 items.
Measured: 1 week after loading the implant.
Patient satisfaction after loading.
This will be measured by a questionnaire with 20 items.
Measured: 1 months after loading.
Patient satisfaction after loading.
This will be measured by a questionnaire with 20 items.
Measured: 6 months after loading
Patient satisfaction after loading.
This will be measured by a questionnaire with 20 items.
Measured: 1 year after loading
Secondary outcomes (6)
Implant level : lost implants, loose implants, …
Measured: From the first week post-surgical to 1 year after loading.
Soft tissue level : Peri-implant inflammation, bleeding index, probing depth
Measured: From the first week post-surgical to 1 year after loading.
Denture related: soft tissue problems.
Measured: From 1 week after insertion of the new complete dentures to 6 months after loading.
Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number.
Measured: From 8 weeks after insertion of the complete dentures to 6 months after loading.
Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus.
Measured: From 1 week after loading the implant to 6 months after loading.
Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi.
Measured: From 8 weeks after insertion of the complete dentures to 6 months after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Single implant in the mandible was finally not indicated due to lack of stability of the denture
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulousStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Implants, South Africa
- Responsible party
- Sponsor
- Investigators
- Jacques Vanobbergen, MD, PhD, Principal investigator, University Hospital Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421849
- Sponsor's protocol ID
- 2011/381
- Status last verified
- Dec 2022
- First submitted
- 22 Aug 2011
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT01421849
- Acronym / sponsor ID
- 2011/381
- Conditions
- Edentulous
- Keywords
- single implant denture, Elderly with an unstable mandibular denture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Single implant in the mandible was finally not indicated due to lack of stability of the denture
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Southern Implants, South Africa
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Aug 2011 (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.
Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture.
In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture.
Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly with an unstable mandibular denture. | Experimental | Procedure: Denture implantation |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Edentulous residents of nursing homes treated in the mobile dental unit 'Gerodent'.
- They have to be willing to commit to 1.5 year of participation in the study.
- They have to be edentulous for at least one year before starting the implant procedure.
Key exclusion criteria (4 listed)
- Medical conditions contraindicating implant surgery (unregulated diabetes type II, bisphosphonates)
- History of radiotherapy in the head and neck region
- Insufficient bone for an implant of at least 10 mm length and 4 mm diameter
- Previously treated with dental implants
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 |
|---|---|---|
| Denture implantationIn a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture. Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments. The total duration of the study will be 12 to 18 months. | Procedure or surgery | Elderly with an unstable mandibular denture. |
Primary outcome
Patient satisfaction after insertion of the new complete dentures.
Time frame: 1 week after insertion of the new complete dentures.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after insertion of the complete dentures.
Time frame: 8 weeks after insertion of the complete dentures.
This will be measured by a questionnaire with 20 items.
Patient satisfaction post-surgical.
Time frame: 1 week post-surgical.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after surgical procedure, functional loading.
Time frame: 6-8 weeks after surgical procedure.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading the implant.
Time frame: 1 week after loading the implant.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading.
Time frame: 1 months after loading.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading.
Time frame: 6 months after loading
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading.
Time frame: 1 year after loading
This will be measured by a questionnaire with 20 items.
6 secondary outcomes
Implant level : lost implants, loose implants, …
Time frame: From the first week post-surgical to 1 year after loading.
Soft tissue level : Peri-implant inflammation, bleeding index, probing depth
Time frame: From the first week post-surgical to 1 year after loading.
Denture related: soft tissue problems.
Time frame: From 1 week after insertion of the new complete dentures to 6 months after loading.
Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number.
Time frame: From 8 weeks after insertion of the complete dentures to 6 months after loading.
Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus.
Time frame: From 1 week after loading the implant to 6 months after loading.
Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi.
Time frame: From 8 weeks after insertion of the complete dentures to 6 months after loading.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Related InfoLink provided by the sponsor.
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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.
Jacques Vanobbergen, MD, PhD principal investigator
University Hospital Ghent, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denture implantation in people with Edentulous, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Dec 2022. 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 Belgium. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 after insertion of the new complete dentures. (time frame: 1 week after insertion of the new complete dentures.). The study lists 8 primary outcomes in all. 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 15 Dec 2022.