Bilateral Sinus Floor Augmentation in Conjunction With Immediate Implant Loading - Study on 3i Dental Implants
1 other identifier
interventional
13
1 country
1
Brief Summary
Fifteen (15) patients completely edentulous in the maxilla will be treated with 8 dental implants. The total treatment will be done in 2 stages to allow, within the same group, a study of two different approaches. Miniscrews that can be functionally loaded will be provided by 3i with the design and surface textures as wanted by the study sponsor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2006
CompletedFirst Posted
Study publicly available on registry
April 26, 2006
CompletedStudy Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2012
CompletedDecember 21, 2022
December 1, 2022
5.3 years
April 11, 2006
December 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Comparison of 3i dental implants installed simultaneously with a sinus lift procedure and immediately loaded
4 months
Comparison of sinus lift with autogenous iliac crest bone + Bio-Oss and sinus lift with an autogenous calvarial skull bone + Bio-Oss
4 months
Installation of implants Prevail and Certain in sinus lift area and naturally healed (non-lifted) bone
4 months
Histological comparison between immediately loaded implants in sinus lifted bone versus normal bone
4 months
Histological comparison at various time intervals
4 months
Histologic findings: integration of the graft, amount of new bone formation, survival and success of the implant, and osseointegration of implant
4 months
Study Arms (1)
Bilateral sinus augmentation
EXPERIMENTALInterventions
Bilateral sinus augmentation with immediately loaded dental implants will be used.
Eligibility Criteria
You may qualify if:
- Healthy volunteers with a full removable denture in the maxilla.
- Subjects must have enough bone to install 4 dental implants in region 14 to 24 and are in need of a sinus lifting procedure in the posterior mandible (region 18-15 + 25-28).
You may not qualify if:
- Patients with compromised healing capacities such as cancer patients and diabetes patients.
- Smokers are excluded when smoking \> 12 cigarettes per day.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo De Bruyn, MD, PhD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2006
First Posted
April 26, 2006
Study Start
September 1, 2007
Primary Completion
December 31, 2012
Study Completion
December 31, 2012
Last Updated
December 21, 2022
Record last verified: 2022-12