Edentulous JawNCT04292132
Two Interforaminal Implants in an Immediate or Delayed Loading Protocol for the Elderly
A study testing Implant placement, immediate loading and conventional loading in people with Edentulous Jaw, run by Medical University of Graz at 1 site in Austria.
Trial summary
The study population comprises 20 completely edentulous patients aged 60 years and older with severe mandible resorption. Each patient receives two inter-foraminal implants (Neoss Ltd., Harrogate, UK). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- Implant placement, immediate loading and conventional loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteAustria
- Study dates
- 2 Jul 2012to 30 Dec 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 or older
- edentulous lower jaw with advanced atrophy
- poor fit and retention even with a new prosthesis
Who cannot join
- poor general condition (ASA classification grade IV or more), or
- high risk situations for implant therapy (e.g. disorders of bone metabolism due to antiresorptive therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung
The study population comprises 20 completely edentulous patients aged 60 years and older with severe mandible resorption. Each patient receives two inter-foraminal implants (Neoss Ltd., Harrogate, UK). Following randomization, implants are loaded either immediately after dental implant surgery or three months after implant placement with the Locator®-abutment system. At follow-up visits 3, 6 12, 24 and 36 months after loading, implant stability is evaluated with Periotest® and Ostell®.
Read the detailed description
Hypothesis:
Especially for gerontoprosthetics, the Locator® abutment system offers the possibility of a minimally invasive retention of prosthetic total restorations of edentulous mandibles. The reduced number of 2 interforaminal implants is intended to ensure implantological anchoring with minimal surgical, technical, financial and time expenditure.
Research Question:
How safe is this minimally invasive and cost-effective implant and anchoring system in terms of long-term outcome? Are the two implant-prosthetic procedures (immediate versus late restoration) different in terms of implant survival time?
Materials and methods
Enrollment:
- 20 patients without relevant pre-existing conditions, from the age of 60 years
- edentulous mandible, alveolar ridge atrophy
Statistical Analysis:
When planning the study, it is estimated that bone resorption in the peri-implant area of the immediate-care implants is greater than in the late-treated implants. 10 patients per group are required with a t-test (α = 0.05) and a power of 80% if the null hypothesis is formulated as follows: -difference of means is 0 and the alternative - expected difference of means is 1mm, common standard deviation is 0.75.
Collective A (open healing - immediate loading): Insertion of a new, prefabricated total mandibular prosthesis on the day of the operation immediately postoperatively after screwing in the Locator® abutments.
Polymerization of the corresponding Locator® matrices in the newly incorporated lower jaw denture in the patient's mouth.
Collective B (closed implant healing - conventional loading): 3 months after implantation Exposure of the primary closed implants. Immediately following insertion of the prefabricated full-thickness UK prosthesis and retention by the implants using Locator® abutments.
Test parameters:
- Intraoperative torque measurement in Ncm
- Radiological measurement of periimplant bone height using orthopantomogram
- 4-point measurement of peri-implant probing depth using WHO periodontal probe. The measurement is mesial, distal, buccal and lingual of the implant.
- Measurement of bleeding on probing (parameters of peri-implant inflammation) using the WHO periodontal probe.
- Analysis of implant stability using the Periotest® and Osstell® measuring instruments according to a standardized scheme: The strength values are performed in a measuring range consisting of a straight line through the center of the implant and the resulting 180 ° circle sector anterior to this line results. After multiple measurements (5-fold) the lowest numerical value for the Periotest® and for the RFA (Osstell®) the lowest value documented.
- Conditions
- Edentulous Jaw
- Being tested
- Implant placement, immediate loading, conventional loading
- Keywords
- Dentistry, Mandibular Atrophy, Mandibular Overdenture
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placementProcedure or surgery
interforaminal placement of 2 implants
immediate loadingProcedure or surgery
immediate loading with a locator retained mandibular overdenture
conventional loadingProcedure or surgery
conventional loading with a locator retained mandibular overdenture 3 months postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Conventional loading | Active comparator | Loading of 4 interforaminal implants three months after surgery. Receives: Procedure: Implant placement; Procedure: conventional loading |
| Immediate Loading | Experimental | Loading of 4 interforaminal implants immediately after surgery. Receives: Procedure: Implant placement; Procedure: immediate loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Implant stability
Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration
Measured: 0,3,6,12,24,36 months
Change of Implant stability
Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration
Measured: 0,3,6,12,24,36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start2 Jul 2012
- Primary completion28 Sep 2015
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Neoss Ltd., Harrogate, UK
- Responsible party
- Sponsor
- Investigators
- Stephan Acham, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292132
- Sponsor's protocol ID
- MUGraz Neoss1
- Status last verified
- Feb 2020
- First submitted
- 26 Jun 2019
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung
- ClinicalTrials.gov ID
- NCT04292132
- Acronym / sponsor ID
- MUGraz Neoss1
- Conditions
- Edentulous Jaw
- Keywords
- Dentistry, Mandibular Atrophy, Mandibular Overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Neoss Ltd., Harrogate, UK
- Study start
- 2 Jul 2012 (actual)
- Primary completion
- 28 Sep 2015 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 2 Mar 2020 (actual)
- 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 study population comprises 20 completely edentulous patients aged 60 years and older with severe mandible resorption. Each patient receives two inter-foraminal implants (Neoss Ltd., Harrogate, UK). Following randomization, implants are loaded either immediately after dental implant surgery or three months after implant placement with the Locator®-abutment system. At follow-up visits 3, 6 12, 24 and 36 months after loading, implant stability is evaluated with Periotest® and Ostell®.
Detailed description
Hypothesis:
Especially for gerontoprosthetics, the Locator® abutment system offers the possibility of a minimally invasive retention of prosthetic total restorations of edentulous mandibles. The reduced number of 2 interforaminal implants is intended to ensure implantological anchoring with minimal surgical, technical, financial and time expenditure.
Research Question:
How safe is this minimally invasive and cost-effective implant and anchoring system in terms of long-term outcome? Are the two implant-prosthetic procedures (immediate versus late restoration) different in terms of implant survival time?
Materials and methods
Enrollment:
- 20 patients without relevant pre-existing conditions, from the age of 60 years
- edentulous mandible, alveolar ridge atrophy
Statistical Analysis:
When planning the study, it is estimated that bone resorption in the peri-implant area of the immediate-care implants is greater than in the late-treated implants. 10 patients per group are required with a t-test (α = 0.05) and a power of 80% if the null hypothesis is formulated as follows: -difference of means is 0 and the alternative - expected difference of means is 1mm, common standard deviation is 0.75.
Collective A (open healing - immediate loading): Insertion of a new, prefabricated total mandibular prosthesis on the day of the operation immediately postoperatively after screwing in the Locator® abutments.
Polymerization of the corresponding Locator® matrices in the newly incorporated lower jaw denture in the patient's mouth.
Collective B (closed implant healing - conventional loading): 3 months after implantation Exposure of the primary closed implants. Immediately following insertion of the prefabricated full-thickness UK prosthesis and retention by the implants using Locator® abutments.
Test parameters:
- Intraoperative torque measurement in Ncm
- Radiological measurement of periimplant bone height using orthopantomogram
- 4-point measurement of peri-implant probing depth using WHO periodontal probe. The measurement is mesial, distal, buccal and lingual of the implant.
- Measurement of bleeding on probing (parameters of peri-implant inflammation) using the WHO periodontal probe.
- Analysis of implant stability using the Periotest® and Osstell® measuring instruments according to a standardized scheme: The strength values are performed in a measuring range consisting of a straight line through the center of the implant and the resulting 180 ° circle sector anterior to this line results. After multiple measurements (5-fold) the lowest numerical value for the Periotest® and for the RFA (Osstell®) the lowest value documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional loading | Active comparator | Procedure: Implant placement, Procedure: conventional loadingLoading of 4 interforaminal implants three months after surgery. |
| Immediate Loading | Experimental | Procedure: Implant placement, Procedure: immediate loadingLoading of 4 interforaminal implants immediately after surgery. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 or older
- edentulous lower jaw with advanced atrophy
- poor fit and retention even with a new prosthesis
Key exclusion criteria (2 listed)
- poor general condition (ASA classification grade IV or more), or
- high risk situations for implant therapy (e.g. disorders of bone metabolism due to antiresorptive therapy)
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 placementinterforaminal placement of 2 implants | Procedure or surgery | Conventional loading, Immediate Loading |
| immediate loadingimmediate loading with a locator retained mandibular overdenture | Procedure or surgery | Immediate Loading |
| conventional loadingconventional loading with a locator retained mandibular overdenture 3 months postoperatively | Procedure or surgery | Conventional loading |
Primary outcome
Change of Implant stability
Time frame: 0,3,6,12,24,36 months
Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration
Change of Implant stability
Time frame: 0,3,6,12,24,36 months
Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration
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 2 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
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Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
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A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
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.
Stephan Acham, MD principal investigator
Medical University of Graz
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, immediate loading and conventional loading in people with Edentulous Jaw, run by Medical University of Graz at 1 site in Austria.
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 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 2 Mar 2020. 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 Austria. 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 of Implant stability (time frame: 0,3,6,12,24,36 months). The study lists 2 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 2 Mar 2020.