Dental ImplantationNCT01644058
Immediate Loading Of Dental Implants: A Pilot Clinical Study
A study testing Immediate loading in people with Dental Implantation, run by Université de Montréal at 1 site in Canada.
Trial summary
Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation
- What is being tested?
- Immediate loading
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimal age of 18 years
- Complete edentulism for more than 1 year
- Wear of total conventional prosthesis for more than 1 year
- Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).
Who cannot join
- Any absolute or relative contra-indication to implant therapy
- Physical incapacity to render oral or prosthetic hygiene
- Incapacity to obtain a free and informed consent
- Incapacity to assist to planned follow up appointments
- Incapacity to understand and complete questionnaires
- Exclusion Criteria to Immediate Loading Protocol Found on One or Both of Un-splinted Implants During Surgery:
- Inadequate bone quality: IT<35 Ncm
- Inadequate primary stability: ISQ<60
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Loading Of Dental Implants In Mandible Full-Arch: A Pilot Clinical Study On Patients Satisfaction, Quality Of Life And Implant Success
Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.
Read the detailed description
In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.
- Conditions
- Dental Implantation
- Being tested
- Immediate loading
- Keywords
- immediate-loading, patient-based outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate loadingProcedure or surgery
Also called Procedure: Immediate loading of 2 endo-osseous unsplinted implants of a mandibular overdenture
| Study group | Role | What they receive |
|---|---|---|
| Immediate loading | Experimental | Immediate loading of 2 endo-osseous mandibular implants Receives: Procedure: Immediate loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction With the Immediate Loading Protocol
Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).
Measured: 4 months
Oral-health-related Quality of Life With the Immediate Loading Protocol
Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJun 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental ImplantationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elham Emami, Université de Montréal
- Investigators
- Elham Emami, DDS, MSc,PhD, Principal investigator, Université de Montréal, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644058
- Sponsor's protocol ID
- UDEM-EE-2012b
- Status last verified
- May 2017
- First submitted
- 16 Jul 2012
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Loading Of Dental Implants In Mandible Full-Arch: A Pilot Clinical Study On Patients Satisfaction, Quality Of Life And Implant Success
- ClinicalTrials.gov ID
- NCT01644058
- Acronym / sponsor ID
- UDEM-EE-2012b
- Conditions
- Dental Implantation
- Keywords
- immediate-loading, patient-based outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 6 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular overdenture assisted by 2 immediately loaded unsplinted implants.
Detailed description
In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left side implants. The midline implant served as a control for within-patient comparison. The immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0), 12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant survival rate, crestal bone level changes and implant stability. These criteria were assessed through clinical and radiographic examinations as well as resonance frequency analysis. Patient-centered outcomes included patient satisfaction and oral health-related quality of life measured using validated questionnaires. Brunner-Langer approach was used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate loading | Experimental | Procedure: Immediate loadingImmediate loading of 2 endo-osseous mandibular implants |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimal age of 18 years
- Complete edentulism for more than 1 year
- Wear of total conventional prosthesis for more than 1 year
- Bone morphology in the anterior mandibular region amendable for the placement of 3 regular diameter implants without any additional procedure (graft or membrane).
Key exclusion criteria (8 listed)
- Any absolute or relative contra-indication to implant therapy
- Physical incapacity to render oral or prosthetic hygiene
- Incapacity to obtain a free and informed consent
- Incapacity to assist to planned follow up appointments
- Incapacity to understand and complete questionnaires
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 |
|---|---|---|
| Immediate loadingAlso: Procedure: Immediate loading of 2 endo-osseous unsplinted implants of a mandibular overdenture | Procedure or surgery | Immediate loading |
Primary outcome
Patient Satisfaction With the Immediate Loading Protocol
Time frame: 4 months
Visual Analogue Scale (VAS) to assess patients' satisfaction, with a score of 100 being extremely satisfied (minimum and maximum scores: 1-100 respectively).
Oral-health-related Quality of Life With the Immediate Loading Protocol
Time frame: 4 months
Oral Health Impact Profile (OHIP-20) to assess oral-health-related quality of life: score ranges between 20 and 120 points, with a lower score indicating a better oral-health-related quality of life.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dental Implantation
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Dental Implant Healing With TNF-Alpha Inhibitors
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
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Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
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Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
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.
Elham Emami, DDS, MSc,PhD principal investigator
Université de Montréal, Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate loading in people with Dental Implantation, run by Université de Montréal 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 4 inclusion and 8 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 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 6 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With the Immediate Loading Protocol (time frame: 4 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 Jun 2017.