Implant Survival Using Immediate Loading ProtocolNCT01949298
Immediate vs Delayed Loading of Two Implants Supporting a Mandibular Over Denture
A study testing dental implant placement in people with Implant Survival Using Immediate Loading Protocol, run by UConn Health at 1 site in United States.
Trial summary
Edentulous patients have to wait after extractions and again after surgical implant placement for healing to occur before the implants can be restored and patients can go back to normal function. This delay in loading of implants can be handicapping for the patient, esthetically and functionally. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Survival Using Immediate Loading Protocol
- What is being tested?
- dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 2014
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females at least >=21y of age
- Provision of informed consent
- Totally edentulous arch requiring or wearing mandibular complete denture
- Tooth in implant sites must have been extracted at least 4 months before the implant placement.
- Adequate amount of bone support to insert a 8mm in length and 4mm in diameter implant without encroaching on vital structures. The amount of bone available should be such that after implant placement there should be minimum of 1mm lingual and buccal bone
- Implant insertion torque >=20Ncm
- No need for bone augmentation procedures
Who cannot join
- Conditions or circumstances as evaluated by the investigator, which would prevent completion of study participation.
- Conditions requiring chronic routine use of antibiotics or requiring prolonged use of steroids.
- History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection
- Use of investigational drugs or devices within 30 days of study period,
- Alcoholism or drug abuse and heavy smokers > 10 cigarettes a day.
- Local factors such as
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- untreated periodontitis,
- erosive lichen planus,
- local irradiation history,
- osseous lesion,
- unhealed extraction socket,
- intraoral infection,
- lack of primary stability
- inadequate oral hygiene
- Simultaneous participation in another clinical study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
Official title: Immediate vs Delayed Loading of Two Implants Supporting a Locator Retained Mandibular Overdenture - A Randomized Controlled Study
Edentulous patients have to wait after extractions and again after surgical implant placement for healing to occur before the implants can be restored and patients can go back to normal function. This delay in loading of implants can be handicapping for the patient, esthetically and functionally. Hence this project was undertaken with the purpose of reducing this wait period and achieving early rehabilitation in these patients. The aim of the project is to compare immediate loading versus delayed loading of implant supported mandibular dentures.
- Being tested
- dental implant placement
- Keywords
- immediate loading of dental implant, implant supported over denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant placementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant loading | Experimental | The test group had implant immediately loaded by means of a implant supported mandibular denture connected with locator abutment. Receives: Procedure: dental implant placement |
| Delayed implant loading group | Active comparator | The control group had implant loaded after 3 months of submerged healing by means of a implant supported mandibular denture connected with locator abutment. Receives: Procedure: dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic bone level change around the implants
Measured: 12 months
Secondary outcomes (1)
Implant survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startJul 2010
- Primary completionJan 2014
- Study completionNov 2014
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 Implant Survival Using Immediate Loading ProtocolStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Astra tech
- Responsible party
- Principal investigator, Gian Schincaglia, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949298
- Sponsor's protocol ID
- IE-10-305-3
- Status last verified
- Dec 2014
- First submitted
- 19 Sep 2013
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Marzola R, Scotti R, Fazi G, Schincaglia GP. Immediate loading of two implants supporting a ball attachment-retained mandibular overdenture: a prospective clinical study. Clin Implant Dent Relat Res. 2007 Sep;9(3):136-43. doi: 10.1111/j.1708-8208.2007.00051.x.
PubMed 17716257Schincaglia GP, Rubin S, Thacker S, Dhingra A, Trombelli L, Ioannidou E. Marginal Bone Response Around Immediate- and Delayed-Loading Implants Supporting a Locator-Retained Mandibular Overdenture: A Randomized Controlled Study. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):448-58. doi: 10.11607/jomi.4118.
PubMed 27004292
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate vs Delayed Loading of Two Implants Supporting a Locator Retained Mandibular Overdenture - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01949298
- Acronym / sponsor ID
- IE-10-305-3
- Keywords
- immediate loading of dental implant, implant supported over denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Dentsply Astra tech
- Study start
- Jul 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Sep 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.
Edentulous patients have to wait after extractions and again after surgical implant placement for healing to occur before the implants can be restored and patients can go back to normal function. This delay in loading of implants can be handicapping for the patient, esthetically and functionally. Hence this project was undertaken with the purpose of reducing this wait period and achieving early rehabilitation in these patients. The aim of the project is to compare immediate loading versus delayed loading of implant supported mandibular dentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate implant loading | Experimental | Procedure: dental implant placementThe test group had implant immediately loaded by means of a implant supported mandibular denture connected with locator abutment. |
| Delayed implant loading group | Active comparator | Procedure: dental implant placementThe control group had implant loaded after 3 months of submerged healing by means of a implant supported mandibular denture connected with locator abutment. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females at least >=21y of age
- Provision of informed consent
- Totally edentulous arch requiring or wearing mandibular complete denture
- Tooth in implant sites must have been extracted at least 4 months before the implant placement.
- Adequate amount of bone support to insert a 8mm in length and 4mm in diameter implant without encroaching on vital structures. The amount of bone available should be such that after implant placement there should be minimum of 1mm lingual and buccal bone
Key exclusion criteria (15 listed)
- Conditions or circumstances as evaluated by the investigator, which would prevent completion of study participation.
- Conditions requiring chronic routine use of antibiotics or requiring prolonged use of steroids.
- History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection
- Use of investigational drugs or devices within 30 days of study period,
- Alcoholism or drug abuse and heavy smokers > 10 cigarettes a day.
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 |
|---|---|---|
| dental implant placement | Procedure or surgery | Delayed implant loading group, Immediate implant loading |
Primary outcome
Radiographic bone level change around the implants
Time frame: 12 months
1 secondary outcome
Implant survival
Time frame: 12 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 3 Dec 2014.
- Background: PubMed 17716257Marzola R, Scotti R, Fazi G, Schincaglia GP. Immediate loading of two implants supporting a ball attachment-retained mandibular overdenture: a prospective clinical study. Clin Implant Dent Relat Res. 2007 Sep;9(3):136-43. doi: 10.1111/j.1708-8208.2007.00051.x.
- Derived from this study: PubMed 27004292Schincaglia GP, Rubin S, Thacker S, Dhingra A, Trombelli L, Ioannidou E. Marginal Bone Response Around Immediate- and Delayed-Loading Implants Supporting a Locator-Retained Mandibular Overdenture: A Randomized Controlled Study. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):448-58. doi: 10.11607/jomi.4118.
Related trials for Implant Survival Using Immediate Loading Protocol
Active, not recruiting
Immediate Loading in Single Tooth Implants
Partial Edentulism Class 3
Enrolling by invitation
Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants
Osseointegration Failure of Dental Implant, Periimplantitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dental implant placement in people with Implant Survival Using Immediate Loading Protocol, run by UConn Health at 1 site in United States.
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 7 inclusion and 15 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 3 Dec 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 United States. 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?
Radiographic bone level change around the implants (time frame: 12 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 NCT01949298, 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 3 Dec 2014.