NCT00906425

Brief Summary

The purpose of this study is To demonstrate that there is no difference in change in bone level around P.004 implants between 1st stage surgery and 6 months post surgery when transmucosal implant placement is compared to submerged implant placement

Trial Health

93
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

Geographic Reach
7 countries

11 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

October 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

August 31, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

May 19, 2009

Results QC Date

June 6, 2012

Last Update Submit

March 2, 2016

Conditions

Jaw, Edentulous, Partially

Keywords

Dental Implant

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)

    The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.

    Baseline and 6 months

Secondary Outcomes (2)

  • Implant Survival Rate

    6 months

  • Implant Survival Rate

    12 months

Study Arms (2)

Submerged healing

ACTIVE COMPARATOR

The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment

Device: Straumann Bone Level Implant

Trans-mucosal healing

ACTIVE COMPARATOR

The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment

Device: Straumann Bone Level Implant

Interventions

Straumann Bone Level ImplantDEVICE

Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Submerged healingTrans-mucosal healing

Eligibility Criteria

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

You may qualify if:

  • Males and females \>18 years of age.
  • Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 - 25, 11 - 15, 31-35, 41-45).
  • Tooth site must have a natural tooth both mesially and distally in the adjacent tooth positions
  • Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations.
  • Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length.
  • Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical manipulation and suturing according to the protocol
  • Signed informed consent document before being treated in the study

You may not qualify if:

  • Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
  • Any contraindications for oral surgical procedures
  • Current untreated periodontitis or gingivitis
  • Probing pocket depth of more than 4 mm at one of the adjacent teeth
  • Mucosal diseases (e.g. erosive lichen planus)
  • History of local irradiation therapy
  • Bone augmentation procedures if the procedure require healing time of more than 12 weeks after implant placement
  • Implants in adjacent position to planned implant
  • Severe bruxing or clenching habits
  • Heavy smokers: Patients who smoke more than 20 cigarettes per day
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation.
  • Patients with inadequate oral hygiene or unmotivated for adequate home care
  • Lack of primary stability of the implant
  • Inappropriate implant position to insert implants according to the prosthetic requirements.
  • Patients with augmentation procedures requiring more than 12 weeks healing time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Dr. Jeffery Ganeles

Boca Raton, Florida, 33431, United States

Location

Dr. William C. Martin

Gainesville, Florida, 32610, United States

Location

Dr. Stephen T. Chen

Melbourne, 3123, Australia

Location

Prof. Wiltfang

Kiel, Schleswig-Holstein, 24105, Germany

Location

Michael Gahlert

München, 80333, Germany

Location

Katharinenhospital

Stuttgart, 70174, Germany

Location

Private Universität Witten/ Herdecke

Witten/ Herdecke, Germany

Location

Dr. Luca Cordaro

Rome, 00198, Italy

Location

Prof. Mariano Sanz

Madrid, 28040, Spain

Location

Dr. Carl-Johan Ivanoff

Mölndal, 43180, Sweden

Location

Christoph Hämmerle

Zurich, 8032, Switzerland

Location

Related Publications (2)

  • Hammerle CHF, Jung RE, Sanz M, Chen S, Martin WC, Jackowski J; this multicenter study group; Ivanoff CJ, Cordaro L, Ganeles J, Weingart D, Wiltfang J, Gahlert M. Submerged and transmucosal healing yield the same clinical outcomes with two-piece implants in the anterior maxilla and mandible: interim 1-year results of a randomized, controlled clinical trial. Clin Oral Implants Res. 2012 Feb;23(2):211-219. doi: 10.1111/j.1600-0501.2011.02210.x. Epub 2011 Jul 4.

    PMID: 21722188RESULT

  • Cordaro L, Torsello F, Chen S, Ganeles J, Bragger U, Hammerle C. Implant-supported single tooth restoration in the aesthetic zone: transmucosal and submerged healing provide similar outcome when simultaneous bone augmentation is needed. Clin Oral Implants Res. 2013 Oct;24(10):1130-6. doi: 10.1111/j.1600-0501.2012.02521.x. Epub 2012 Jun 15.

    PMID: 22697581RESULT

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Results Point of Contact

Title
Michael Hotze, PhD
Organization
Institut Straumann
michael.hotze@straumann.com
+4161965

Study Officials

  • Christoph Hammerle

    University of Zurich

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 21, 2009

Study Start

October 1, 2006

Primary Completion

June 1, 2008

Study Completion

October 1, 2013

Last Updated

March 30, 2016

Results First Posted

August 31, 2012

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)CH(1)DE(4)AU(1)US(2)IT(1)ES(1)