NCT02161874

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

5.8 years

First QC Date

June 10, 2014

Last Update Submit

March 24, 2022

Conditions

Partial EdentulismTooth Disease

Keywords

edentulismdental implantsclinical studyendosseousrandomizedcrestal bone levelT3Nanotite CertainNanotite Certain PrevailTapered

Outcome Measures

Primary Outcomes (1)

  • Cumulative success rate

    Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles.

    1 year

Secondary Outcomes (1)

  • Crestal bone changes

    2 years

Study Arms (2)

T3 with DCD tapered implant

EXPERIMENTAL

T3 with DCD tapered prevail implant

Device: T3 with DCD tapered Prevail implant

Nanotite certain tapered implant

ACTIVE COMPARATOR

Nanotite Certain tapered implant

Device: Nanotite Certain tapered implant

Interventions

T3 with DCD tapered Prevail implantDEVICE

T3 with DCD implant with Certain (internal) connection and platform-switch design

Also known as: T3 with Nanotite, T3 with platform switch
T3 with DCD tapered implant
Nanotite Certain tapered implantDEVICE

Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design

Also known as: Nanotite tapered certain, Non-platform switched
Nanotite certain tapered implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dr. Tommie VanDeVelde

Antwerp, Belgium

Location

Dr. Dominique Caspar

Les Bains, France

Location

Dr. Felix Hanssler

Göppingen, Germany

Location

Dr. Nicholas Lewis

London, United Kingdom

Location

MeSH Terms

Conditions

Tooth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Study Officials

  • Nicholas Lewis, DMD

    Eastman Dental Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

April 1, 2013

Primary Completion

January 1, 2019

Study Completion

July 1, 2020

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)BE(1)FR(1)DE(1)