Jaw, EdentulousNCT02107612
Randomized Study For Minimally Invasive Splinted Implants
A study testing Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture and Denture in people with Jaw, Edentulous, run by University of Concepcion, Chile at 1 site in Chile.
Trial summary
The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture and Denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChile
- Study dates
- Jul 2004to Jul 2007
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Edentulous
- Men and women
- Between 45 and 90 years of age
- Who had a persistent loss of stability and retention of their conventional mandibular dentures
- Without temporomandibular disorders
Who cannot join
- Uncontrolled systemic disease (eg, hypertension, diabetes)
- Severe osteoporosis (bone mineral density > 2.5 SD below the young adult reference mean, plus 1 or more fragility fractures) and/or taking bisphosphonates
- Mental disorders
- Who had received radiotherapy in the 18 months prior to the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Minimally Invasive Splinted Dental Implants to Stabilize Mandibular Overdentures, a Randomized Clinical Trial
The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients.
- Conditions
- Jaw, Edentulous
- Being tested
- Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture, Denture
- Keywords
- Mini-Dental Implant, Implant-Supported Dental Prosthesis, Minimally Invasive Surgical procedures, Overdentures, Aged
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated system to insert two splinted (bar) mini dental implants for mandibular overdentureDevice
Also called Easy2Fix
DentureOther
| Study group | Role | What they receive |
|---|---|---|
| Integrated system to insert two splinted (bar) miniimplants | Experimental | Participants were randomly assigned to experimental group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator. Receives: Device: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture |
| Denture | Active comparator | Participants were randomly assigned to comparator group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator. Receives: Other: Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
Quality of life was assessed using the Oral Health Impact Profile (OHIP) for assessing health-related quality of life in edentulous adults (EDENT) scale with 19 items.
Measured: One year
Secondary outcomes (1)
Incidence of complications
Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startJul 2004
- Primary completionApr 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw, EdentulousStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Concepcion, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Service of Chile
- Responsible party
- Principal investigator, Jorge Jofre, University of Concepcion, Chile
- Investigators
- Jorge Jofre, DDS, PhD, Principal investigator, University of Concepcion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107612
- Sponsor's protocol ID
- FONDEF V09E0007
- Status last verified
- Apr 2014
- First submitted
- 4 Apr 2014
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jofre J, Castiglioni X, Lobos CA. Influence of minimally invasive implant-retained overdenture on patients' quality of life: a randomized clinical trial. Clin Oral Implants Res. 2013 Oct;24(10):1173-7. doi: 10.1111/j.1600-0501.2012.02529.x. Epub 2012 Jul 4.
PubMed 22762359Jofre J, Cendoya P, Munoz P. Effect of splinting mini-implants on marginal bone loss: a biomechanical model and clinical randomized study with mandibular overdentures. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1137-44.
PubMed 21197490Jofre J, Conrady Y, Carrasco C. Survival of splinted mini-implants after contamination with stainless steel. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):351-6.
PubMed 20369095Jofre J, Hamada T, Nishimura M, Klattenhoff C. The effect of maximum bite force on marginal bone loss of mini-implants supporting a mandibular overdenture: a randomized controlled trial. Clin Oral Implants Res. 2010 Feb;21(2):243-9. doi: 10.1111/j.1600-0501.2009.01834.x.
PubMed 20070758
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Minimally Invasive Splinted Dental Implants to Stabilize Mandibular Overdentures, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02107612
- Acronym / sponsor ID
- FONDEF V09E0007
- Conditions
- Jaw, Edentulous
- Keywords
- Mini-Dental Implant, Implant-Supported Dental Prosthesis, Minimally Invasive Surgical procedures, Overdentures, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of Concepcion, ChileUniversity, hospital or other
- Collaborators
- Public Health Service of Chile
- Study start
- Jul 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 8 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.
The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated system to insert two splinted (bar) miniimplants | Experimental | Device: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdentureParticipants were randomly assigned to experimental group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator. |
| Denture | Active comparator | Other: DentureParticipants were randomly assigned to comparator group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Edentulous
- Men and women
- Between 45 and 90 years of age
- Who had a persistent loss of stability and retention of their conventional mandibular dentures
- Without temporomandibular disorders
Key exclusion criteria (4 listed)
- Uncontrolled systemic disease (eg, hypertension, diabetes)
- Severe osteoporosis (bone mineral density > 2.5 SD below the young adult reference mean, plus 1 or more fragility fractures) and/or taking bisphosphonates
- Mental disorders
- Who had received radiotherapy in the 18 months prior to the trial
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 |
|---|---|---|
| Integrated system to insert two splinted (bar) mini dental implants for mandibular overdentureAlso: Easy2Fix | Device | Integrated system to insert two splinted (bar) miniimplants |
| Denture | Other | Denture |
Primary outcome
Change in Quality of Life
Time frame: One year
Quality of life was assessed using the Oral Health Impact Profile (OHIP) for assessing health-related quality of life in edentulous adults (EDENT) scale with 19 items.
1 secondary outcome
Incidence of complications
Time frame: Two years
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 9 Apr 2014.
- Results publication: PubMed 22762359Jofre J, Castiglioni X, Lobos CA. Influence of minimally invasive implant-retained overdenture on patients' quality of life: a randomized clinical trial. Clin Oral Implants Res. 2013 Oct;24(10):1173-7. doi: 10.1111/j.1600-0501.2012.02529.x. Epub 2012 Jul 4.
- Results publication: PubMed 21197490Jofre J, Cendoya P, Munoz P. Effect of splinting mini-implants on marginal bone loss: a biomechanical model and clinical randomized study with mandibular overdentures. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1137-44.
- Results publication: PubMed 20369095Jofre J, Conrady Y, Carrasco C. Survival of splinted mini-implants after contamination with stainless steel. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):351-6.
- Results publication: PubMed 20070758Jofre J, Hamada T, Nishimura M, Klattenhoff C. The effect of maximum bite force on marginal bone loss of mini-implants supporting a mandibular overdenture: a randomized controlled trial. Clin Oral Implants Res. 2010 Feb;21(2):243-9. doi: 10.1111/j.1600-0501.2009.01834.x.
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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.
Jorge Jofre, DDS, PhD principal investigator
University of Concepcion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture and Denture in people with Jaw, Edentulous, run by University of Concepcion, Chile at 1 site in Chile.
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 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: finished, as of the sponsor's last update on 9 Apr 2014. 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 Chile. 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 in Quality of Life (time frame: One year). 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 NCT02107612, which also lists 4 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 9 Apr 2014.