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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02161874
Other study ID # 3023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date July 2020

Study information

Verified date March 2022
Source ZimVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2020
Est. primary completion date January 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
T3 with DCD tapered Prevail implant
T3 with DCD implant with Certain (internal) connection and platform-switch design
Nanotite Certain tapered implant
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design

Locations

Country Name City State
Belgium Dr. Tommie VanDeVelde Antwerp
France Dr. Dominique Caspar Les Bains
Germany Dr. Felix Hanssler Goppingen
United Kingdom Dr. Nicholas Lewis London

Sponsors (1)

Lead Sponsor Collaborator
ZimVie

Countries where clinical trial is conducted

Belgium,  France,  Germany,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative success rate Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles. 1 year
Secondary Crestal bone changes Crestal bone regression (amount of bone loss) between the two treatment groups will be compared 2 years
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