Dental ImplantsNCT01107600
Study on Immediate Loading of Immediately Placed Single Implants.
A study testing Immediate implant and socket preservation in people with Dental Implants, run by Hospital San Pietro Fatebenefratelli at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate survival and success rates of dental implants placed with immediate loading protocol in extraction sockets. All patients were monitored for 1 year after implants placement. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Immediate implant and socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesItaly
- Study dates
- Jun 2010to Jun 2011
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Single-tooth implant restorations in the aesthetic zone
Who cannot join
- Medical risk patient
- Smoking
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Marco Tallarico
Rome, 00151
Odontoiatric center San Pietro Hospital, FBF
Rome, 00189
About this study
Official title: Study on Immediate Loading of Immediately Placed Single Implants in Extraction Sockets With Nobel Active™ Implants and Bio-oss®.
The purpose of this study is to evaluate survival and success rates of dental implants placed with immediate loading protocol in extraction sockets. All patients were monitored for 1 year after implants placement.
Read the detailed description
The international literature supported the potential advantages offered by this approach, but indicated a higher risk when compared with immediate loading in healed ridges.
The hypothesis to demonstrate is an high success and survival rates of Nobel Active™ implants used in combination with Bio-Oss® material.
- Conditions
- Dental Implants
- Being tested
- Immediate implant and socket preservation
- Keywords
- Dental Implants, Single-Tooth, Bone Regeneration, Dental Restoration, Socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant and socket preservationProcedure or surgery
Implant placed in fresh extraction sockets as part of the same surgical procedure, and placed into occlusal loading within 48 h of implant placement. Guided bone regeneration with Biomaterial to preserve bone loss after tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Nobel Active® | Experimental | Immediate implant and socket preservation Receives: Procedure: Immediate implant and socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability quote (ISQ) measurements.
Measured by Ostell® Mentor Device.
Measured: 8 weeks
Secondary outcomes (1)
Aesthetic Results and Patient Satisfaction
Bone crest level changes measured by standardized intraoral radiographs.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJun 2010 (estimated)
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Why it stopped: Principal investigator and sponsor did not reach an agreement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Model description
- Immediate loading
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Pietro Fatebenefratelli
- Sponsor type
- University, hospital or other
- Collaborators
- Nobel Biocare, Geistlich Pharma AG
- Responsible party
- Principal investigator, Marco Tallarico, Hospital San Pietro Fatebenefratelli
- Investigators
- Marco Gargari, Professor, Study director, San Pietro Hospital, FBF, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107600
- Sponsor's protocol ID
- HSPFBF-NB-02
- Status last verified
- Aug 2018
- First submitted
- 19 Apr 2010
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atieh MA, Payne AG, Duncan WJ, Cullinan MP. Immediate restoration/loading of immediately placed single implants: is it an effective bimodal approach? Clin Oral Implants Res. 2009 Jul;20(7):645-59. doi: 10.1111/j.1600-0501.2009.01725.x.
PubMed 19515058
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Immediate Loading of Immediately Placed Single Implants in Extraction Sockets With Nobel Active™ Implants and Bio-oss®.
- ClinicalTrials.gov ID
- NCT01107600
- Acronym / sponsor ID
- HSPFBF-NB-02
- Conditions
- Dental Implants
- Keywords
- Dental Implants, Single-Tooth, Bone Regeneration, Dental Restoration, Socket preservation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal investigator and sponsor did not reach an agreement.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital San Pietro FatebenefratelliUniversity, hospital or other
- Collaborators
- Nobel Biocare, Geistlich Pharma AG
- Study start
- Jun 2010 (estimated)
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 21 Apr 2010 (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 evaluate survival and success rates of dental implants placed with immediate loading protocol in extraction sockets. All patients were monitored for 1 year after implants placement.
Detailed description
The international literature supported the potential advantages offered by this approach, but indicated a higher risk when compared with immediate loading in healed ridges.
The hypothesis to demonstrate is an high success and survival rates of Nobel Active™ implants used in combination with Bio-Oss® material.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Immediate loading
| Arm | Type | Receives |
|---|---|---|
| Nobel Active® | Experimental | Procedure: Immediate implant and socket preservationImmediate implant and socket preservation |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Single-tooth implant restorations in the aesthetic zone
Key exclusion criteria (2 listed)
- Medical risk patient
- Smoking
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 implant and socket preservationImplant placed in fresh extraction sockets as part of the same surgical procedure, and placed into occlusal loading within 48 h of implant placement. Guided bone regeneration with Biomaterial to preserve bone loss after tooth extraction. | Procedure or surgery | Nobel Active® |
Primary outcome
Implant stability quote (ISQ) measurements.
Time frame: 8 weeks
Measured by Ostell® Mentor Device.
1 secondary outcome
Aesthetic Results and Patient Satisfaction
Time frame: 1 year
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 17 Aug 2018.
- Background: PubMed 19515058Atieh MA, Payne AG, Duncan WJ, Cullinan MP. Immediate restoration/loading of immediately placed single implants: is it an effective bimodal approach? Clin Oral Implants Res. 2009 Jul;20(7):645-59. doi: 10.1111/j.1600-0501.2009.01725.x.
Related trials for Dental Implants
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
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Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
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Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
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Movement of Dental Implants During Osseointegration
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Changes in Oral Health-related Quality of Life (OHRQoL) During Full Arch Implant Treatment
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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.
Marco Gargari, Professor study director
San Pietro Hospital, FBF, Roma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate implant and socket preservation in people with Dental Implants, run by Hospital San Pietro Fatebenefratelli at 2 sites in Italy.
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 2 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: withdrawn, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Implant stability quote (ISQ) measurements. (time frame: 8 weeks). 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 NCT01107600, which also lists 1 linked publication.
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 17 Aug 2018.