NCT00422279

Brief Summary

The purpose of the study is to evaluate implant stability and stimulate clinically relevant horizontal and vertical new bone formation around Nobel Biocare's Bone Inductive Implant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

May 29, 2015

Completed
Last Updated

April 20, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

January 11, 2007

Results QC Date

January 17, 2012

Last Update Submit

March 22, 2016

Conditions

Alveolar Ridge Abnormality

Keywords

Bone Inductive Implant

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint Was to Assess Implant Stability of the Implants( 4 Patients in Two Groups With a Total of 8 Implants) at Baseline and After 3 Months of Submerged Healing and After 6 Months of Prosthetic Loading

    The following success criteria for the primary endpoint have been adopted and apply to both treatment groups. 1.The implant stability (ISQ) was recorded by means of resonance frequency analysis (RFA) at implant insertion, 3 months and after 6 months of loading 2. radiographic and computed tomography analyses shall not show any signs of peri-implant radiolucency at the 3 and 6 month time point 3. implant stability after 3 months shall allow tightening to 35Ncm without implant rotation by using a torque wrench

    Implant insertion, 3 months, 6 months

Secondary Outcomes (1)

  • Number of Participants Showing Bone Growth With rhBMP-2 (15 and 30 µg Per Implant)

    3 months

Study Arms (2)

supraalevolar

EXPERIMENTAL

Bone inductive implant (Nobel Replace Tapered Groovy) placed in the supralveolar position

Device: Nobel Replace Tapered Groovy

Other

EXPERIMENTAL

Bone inductive implant (Nobel Replace Tapered Groovy) placed in extraction socket

Device: Nobel Replace Tapered Groovy

Interventions

Nobel Replace Tapered GroovyDEVICE

Bone inductive implant placed in supralveoral position or extraction site

Also known as: Bone inductive implant
Othersupraalevolar

Eligibility Criteria

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

You may qualify if:

  • Above the age of 18 years.
  • teeth or more are missing either upper/lower jaw (Treatment Gp 1)
  • or more teeth require extraction either upper/lower jaw.(Treatment Gp 2)

You may not qualify if:

  • Medical risk patients
  • Smoking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Related Publications (2)

  • Becker W, Wikesjo UM, Sennerby L, Qahash M, Hujoel P, Goldstein M, Turkyilmaz I. Histologic evaluation of implants following flapless and flapped surgery: a study in canines. J Periodontol. 2006 Oct;77(10):1717-22. doi: 10.1902/jop.2006.060090.

    PMID: 17032115RESULT

  • Wikesjo UM, Susin C, Qahash M, Polimeni G, Leknes KN, Shanaman RH, Prasad HS, Rohrer MD, Hall J. The critical-size supraalveolar peri-implant defect model: characteristics and use. J Clin Periodontol. 2006 Nov;33(11):846-54. doi: 10.1111/j.1600-051X.2006.00985.x. Epub 2006 Sep 11.

    PMID: 16965525RESULT

Results Point of Contact

Title
Isabelle Arrighi, Head Clinical Trial Management
Organization
Nobel Biocare
isabelle.arrighi@nobelbiocare.com
+41 43 211 42 00

Study Officials

  • PHILIP J HANES, DDS

    Augusta University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

November 1, 2006

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

April 20, 2016

Results First Posted

May 29, 2015

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)