NCT02096978

Brief Summary

The study will be conducted to compare two alternative techniques for dental implant placement. Both of the techniques - Osteotome and Conventional Drilling Techniques for the preparation of the implant sites (osteotomies) are accepted standards of care. The goal of the study will be to compare implant stabilities achieved with two techniques by measuring resonance frequency for each implant placed using the diagnostic device, the Osstell machine, that measures "stiffness" of the bone/implant system non-invasively. The data are represented in a quantitative value - implant stability quotient (ISQ), where a higher value indicated a higher implant stability. Since it has been well documented in the scientific literature that primary (at the time of implant placement) implant stability is a strong prerequisite for implant success (osseointegration and subsequent function on loading), the results of this study will guide the implant team in choosing the right surgical treatment protocol - the protocol that will be aimed for higher implant stability, and, therefore, for higher long-term implant success.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2010

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

October 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

2.5 years

First QC Date

March 18, 2014

Last Update Submit

March 25, 2014

Conditions

Implant

Keywords

ImplantStabilityplacementOsteotome

Outcome Measures

Primary Outcomes (1)

  • Necessary stability to insert prosthesis by RFA units

    Stability to be measured by RFA units

    90 days

Study Arms (2)

Osteotome preparation

EXPERIMENTAL

Procedure/Surgery: Preparing the osteotomy to accept a standard implant device

Procedure: Preparing the osteotomy to accept a standard implant device

Drill preparation

ACTIVE COMPARATOR

Preparing the osteotomy to accept a standard implant device

Procedure: Preparing the osteotomy to accept a standard implant device

Interventions

Preparing the osteotomy to accept a standard implant devicePROCEDURE

Preparing the osteotomy with one of two randomly assigned protocols

Drill preparationOsteotome preparation

Eligibility Criteria

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

You may qualify if:

  • One maxillary implant fixture per patient indicated by the treatment plan.
  • No previous implant attempted in the area
  • No previous GBR or sinus lift done
  • No GBR or sinus lift needed
  • A minimum of 7mm of horizontal bone and a minimum of 12mm of vertical height will be needed to accommodate a 4x10mm fixture.

You may not qualify if:

  • History of diabetes, HIV+, radiation therapy, smoking, oral/intravenous bisphosphonates intake.
  • Pregnant women
  • Maxillary bone density of Type D1/Type D2, as determined by a preoperative three-dimensional imaging.
  • No grafted sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07101, United States

Location

Related Publications (4)

  • Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.

    PMID: 8055503BACKGROUND

  • Buchter A, Kleinheinz J, Wiesmann HP, Kersken J, Nienkemper M, Weyhrother Hv, Joos U, Meyer U. Biological and biomechanical evaluation of bone remodelling and implant stability after using an osteotome technique. Clin Oral Implants Res. 2005 Feb;16(1):1-8. doi: 10.1111/j.1600-0501.2004.01081.x.

    PMID: 15642025BACKGROUND

  • Stavropoulos A, Nyengaard JR, Lang NP, Karring T. Immediate loading of single SLA implants: drilling vs. osteotomes for the preparation of the implant site. Clin Oral Implants Res. 2008 Jan;19(1):55-65. doi: 10.1111/j.1600-0501.2007.01422.x. Epub 2007 Oct 22.

    PMID: 17956566BACKGROUND

  • Devlin H, Horner K, Ledgerton D. A comparison of maxillary and mandibular bone mineral densities. J Prosthet Dent. 1998 Mar;79(3):323-7. doi: 10.1016/s0022-3913(98)70245-8.

    PMID: 9553887BACKGROUND

Study Officials

  • Howard J Drew, DMD

    Rutgers School of Dental Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 26, 2014

Study Start

October 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)