Back to resultsEvaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System (OAK)
Primary Purpose
Partial Edentulism, Tooth Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
T3 with DCD tapered Prevail implant
Nanotite Certain tapered implant
Sponsored by
About this trial
This is an interventional treatment trial for Partial Edentulism focused on measuring edentulism, dental implants, clinical study, endosseous, randomized, crestal bone level, T3, Nanotite Certain, Nanotite Certain Prevail, Tapered
Eligibility Criteria
Inclusion Criteria:
- Patients of either sex and any race greater than 18 years of age
- Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits
Exclusion Criteria:
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a > 10 cigarette per day smoking habit.
- Patients with uncontrolled diabetes mellitus.
- Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
- Patients with a history of therapeutic radiation to the head
- Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
- Patients who are known to be pregnant at the screening visit.
- Patients with evidence of severe para-functional habits such as bruxing or clenching.
Sites / Locations
- Dr. Tommie VanDeVelde
- Dr. Dominique Caspar
- Dr. Felix Hanssler
- Dr. Nicholas Lewis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T3 with DCD tapered implant
Nanotite certain tapered implant
Arm Description
T3 with DCD tapered prevail implant
Nanotite Certain tapered implant
Outcomes
Primary Outcome Measures
Cumulative success rate
Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
Secondary Outcome Measures
Crestal bone changes
Crestal bone regression (amount of bone loss) between the two treatment groups will be compared
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02161874
Brief Title
Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System
Acronym
OAK
Official Title
A Prospective, Randomized-controlled Evaluation of Biomet 3i's T3 Implant System for Integration Success and the Preservation of Crestal Bone
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZimVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.
Detailed Description
This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio.
All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter.
Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Edentulism, Tooth Disease
Keywords
edentulism, dental implants, clinical study, endosseous, randomized, crestal bone level, T3, Nanotite Certain, Nanotite Certain Prevail, Tapered
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T3 with DCD tapered implant
Arm Type
Experimental
Arm Description
T3 with DCD tapered prevail implant
Arm Title
Nanotite certain tapered implant
Arm Type
Active Comparator
Arm Description
Nanotite Certain tapered implant
Intervention Type
Device
Intervention Name(s)
T3 with DCD tapered Prevail implant
Other Intervention Name(s)
T3 with Nanotite, T3 with platform switch
Intervention Description
T3 with DCD implant with Certain (internal) connection and platform-switch design
Intervention Type
Device
Intervention Name(s)
Nanotite Certain tapered implant
Other Intervention Name(s)
Nanotite tapered certain, Non-platform switched
Intervention Description
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
Primary Outcome Measure Information:
Title
Cumulative success rate
Description
Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Crestal bone changes
Description
Crestal bone regression (amount of bone loss) between the two treatment groups will be compared
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of either sex and any race greater than 18 years of age
Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla.
Patients must be physically able to tolerate conventional surgical and restorative procedures.
Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits
Exclusion Criteria:
Patients with active infection or severe inflammation in the areas intended for implant placement.
Patients with a > 10 cigarette per day smoking habit.
Patients with uncontrolled diabetes mellitus.
Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone.
Patients with a history of therapeutic radiation to the head
Patients in need of bone grafting at the site of the intended study implant for augmentation purposes.
Patients who are known to be pregnant at the screening visit.
Patients with evidence of severe para-functional habits such as bruxing or clenching.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Lewis, DMD
Organizational Affiliation
Eastman Dental Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Tommie VanDeVelde
City
Antwerp
Country
Belgium
Facility Name
Dr. Dominique Caspar
City
Les Bains
Country
France
Facility Name
Dr. Felix Hanssler
City
Goppingen
Country
Germany
Facility Name
Dr. Nicholas Lewis
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System
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