Clinical trial NCT02161874: Evaluation of Integration Success and Crestal Bone Preservation Biomet 3i's T3 Implant System
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
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
Keywords: edentulism
dental implants
clinical study
endosseous
randomized
crestal bone level
T3
Nanotite Certain
Nanotite Certain Prevail
Tapered
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2014-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cumulative success rate
timeFrame: 1 year
Secondary outcomes:
measure: Crestal bone changes
timeFrame: 2 years
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Dr. Tommie VanDeVelde
city: Les Bains
country: France
facility: Dr. Dominique Caspar
city: Goppingen
country: Germany
facility: Dr. Felix Hanssler
city: London
country: United Kingdom
facility: Dr. Nicholas Lewis
Study officials:
affiliation: Eastman Dental Hospital
name: Nicholas Lewis, DMD
role: PRINCIPAL_INVESTIGATOR
References: