Edentulous Complete Denture WearersNCT01928004
Mandibular Implants in Elderly Patients
A study testing Implant placement and Conventional reline in people with Edentulous Complete Denture Wearers, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Complete Denture Wearers
- What is being tested?
- Implant placement and Conventional reline
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Apr 2019
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 75 years or older
- living institutionalized or receiving help for the ADL
- edentulous
- wearing complete dentures
- the lower denture had to cause discomfort to the degree that the patients were seeking treatment
Who cannot join
- severe clinical depression
- dementia
- poorly controlled diabetes
- immunosuppression
- treatment with bisphosphonates
- condition precluding the surgical intervention for implant placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.
- Conditions
- Edentulous Complete Denture Wearers
- Being tested
- Implant placement, Conventional reline
- Keywords
- edentulous, complete 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.
Implant placementDevice
Also called Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter), Locator® attachments (Zest Anchors: Escondido, CA, USA)
Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.
Conventional relineProcedure or surgery
conventional reline of the existing mandibular complete denture
| Study group | Role | What they receive |
|---|---|---|
| implant placement | Experimental | insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture Receives: Device: Implant placement |
| denture reline | Active comparator | conventional reline of mandibular complete denture Receives: Procedure: Conventional reline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Denture satisfaction
VAS-scale score to evaluate the subjective satisfaction with the denture
Measured: at 3, 12, 24 and 36 months
Secondary outcomes (14)
Change from Baseline in OHRQoL
OHIP-Edent questionnaire, 20 questions
Measured: at 3, 12, 24 adn 36 months
Change from Baseline in cognitive function
Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test
Measured: at 12, 24 and 36 months
Change from Baseline in Independence
IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence
Measured: at 12, 24 and 36 months
Change from Baseline in MNA
Mini-nutritional Assessement questionnaire (Guigoz 1994)
Measured: at 3, 12, 24 and 36 months
Change from Baseline in Blood markers
Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)
Measured: at 3, 12, 24 and 36 months
Change from Baseline in BMI
Body Mass Index kg/m2
Measured: at 12, 24 and 36 months
Change from Insertion in implant survival
inserted implants in vivo
Measured: at 3, 12, 24 and 36 months
Change from Insertion in Pocket depth
mesial and distal peri-implant probing depth
Measured: at 3, 12, 24 and 36 months
Change from Insertion in Plaque index
Plaque index on implants (Silness \& Loe 1963) Denture plaque index
Measured: at 3, 12, 24 and 36 months
Change from Insertion in peri-implant bone loss
mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs
Measured: at 3, 12, 24 and 36 months
Change from Baseline in Chewing efficiency
two color mixing test with bi-colored chewing gum (Schimmel et al 2007)
Measured: at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Maximum bite force
unilateral maximal bite force measured with force gauge
Measured: at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Stimulated Saliva Flow Rate
whole saliva collected after chewing wax for 2 minutes on one side
Measured: at Intervention, 3, 12, 24 and 36 months
Changes from Baseline in Masseter Muscle Thickness
ultrasound measurements of the masseter muscle thickness in contracted and relaxed state
Measured: at 3, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startSep 2007
- Primary completionApr 2012
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Edentulous Complete Denture WearersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frauke Müller, University of Geneva, Switzerland
- Investigators
- Frauke Müller, Prof. Dr. med. dent., Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928004
- Sponsor's protocol ID
- MDGPA_02
- Other IDs
- ITI_458_2006
- Status last verified
- Apr 2021
- First submitted
- 16 Aug 2013
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.
PubMed 24158342Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Muller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implants Res. 2019 Jan;30(1):59-67. doi: 10.1111/clr.13392. Epub 2018 Dec 30.
PubMed 30500094
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01928004
- Acronym / sponsor ID
- MDGPA_02
- Conditions
- Edentulous Complete Denture Wearers
- Keywords
- edentulous, complete denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 23 Aug 2013 (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.
The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant placement | Experimental | Device: Implant placementinsertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture |
| denture reline | Active comparator | Procedure: Conventional relineconventional reline of mandibular complete denture |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 75 years or older
- living institutionalized or receiving help for the ADL
- edentulous
- wearing complete dentures
- the lower denture had to cause discomfort to the degree that the patients were seeking treatment
Key exclusion criteria (6 listed)
- severe clinical depression
- dementia
- poorly controlled diabetes
- immunosuppression
- treatment with bisphosphonates
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 |
|---|---|---|
| Implant placementAlso: Straumann Standard Implants® (SLA surface, 8mm length, RN, 4.1mm diameter), Locator® attachments (Zest Anchors: Escondido, CA, USA)Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD. | Device | implant placement |
| Conventional relineconventional reline of the existing mandibular complete denture | Procedure or surgery | denture reline |
Primary outcome
Change from Baseline in Denture satisfaction
Time frame: at 3, 12, 24 and 36 months
VAS-scale score to evaluate the subjective satisfaction with the denture
14 secondary outcomes
Change from Baseline in OHRQoL
Time frame: at 3, 12, 24 adn 36 months
Change from Baseline in cognitive function
Time frame: at 12, 24 and 36 months
Change from Baseline in Independence
Time frame: at 12, 24 and 36 months
Change from Baseline in MNA
Time frame: at 3, 12, 24 and 36 months
Change from Baseline in Blood markers
Time frame: at 3, 12, 24 and 36 months
Change from Baseline in BMI
Time frame: at 12, 24 and 36 months
Change from Insertion in implant survival
Time frame: at 3, 12, 24 and 36 months
Change from Insertion in Pocket depth
Time frame: at 3, 12, 24 and 36 months
Change from Insertion in Plaque index
Time frame: at 3, 12, 24 and 36 months
Change from Insertion in peri-implant bone loss
Time frame: at 3, 12, 24 and 36 months
Change from Baseline in Chewing efficiency
Time frame: at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Maximum bite force
Time frame: at Intervention, 3, 12, 24 and 36 months
Change from Baseline in Stimulated Saliva Flow Rate
Time frame: at Intervention, 3, 12, 24 and 36 months
Changes from Baseline in Masseter Muscle Thickness
Time frame: at 3, 12, 24 and 36 months
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 30 Apr 2021.
- Results publication: PubMed 24158342Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.
- Results publication: PubMed 30500094Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Muller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implants Res. 2019 Jan;30(1):59-67. doi: 10.1111/clr.13392. Epub 2018 Dec 30.
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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.
Frauke Müller, Prof. Dr. med. dent. principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement and Conventional reline in people with Edentulous Complete Denture Wearers, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 5 inclusion and 6 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 30 Apr 2021. 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 Switzerland. 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 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?
Change from Baseline in Denture satisfaction (time frame: at 3, 12, 24 and 36 months). 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 NCT01928004, which also lists 2 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 30 Apr 2021.