NCT01960361

Brief Summary

The current prospective clinical study's aim is to determine ABT's ICE implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of ICE implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 9, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 16, 2019

Status Verified

June 1, 2019

Enrollment Period

4.2 years

First QC Date

October 9, 2013

Last Update Submit

July 14, 2019

Conditions

Implant Clinical SurvivalDental Implant Bone Loss

Outcome Measures

Primary Outcomes (1)

  • Cumulative Survival Rate

    24 MONTHS

Study Arms (1)

ICE dental implant

EXPERIMENTAL

Subjects implanted with ICE implant

Device: ICE dental implant

Interventions

ICE dental implantDEVICE

ICE- Implant Classical Esthetic implant

ICE dental implant

Eligibility Criteria

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

You may qualify if:

  • Men and women over the age of 18 years who need implantation of 1-4 implants.
  • Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
  • Patients who had provided written informed consent to participate in the study prior to any study procedure.
  • Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.

You may not qualify if:

  • Immediate loaded implants.
  • Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
  • Treatment with anticonvulsants drugs.
  • Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
  • Patients with history of alcohol, narcotics or drug abuse.
  • Patients under steroid therapy.
  • Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years.
  • Patients through at anytime received radiotherapy to the head and neck region will be excluded anyway.
  • Metabolic bone disorders and/or bone augmentation.
  • Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
  • Degenerative diseases.
  • Osteoradionecrosis.
  • Renal failure.
  • Organ transplant recipients.
  • HIV positive.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Rishon LeZiyyon, 70300, Israel

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 10, 2013

Study Start

January 1, 2015

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

July 16, 2019

Record last verified: 2019-06

Locations

IL(1)