Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00906425
First received: May 19, 2009
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Jaw, Edentulous, Partially
Device: Straumann Bone Level Implant

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Controlled Clinical Study Comparing Submerged vs. Trans-mucosal Placement of P.004 Implants in the Anterior Maxilla and Mandible by Evaluation of the Change in Bone Level Between 1st Stage Surgery and 6 Months Post Surgery

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Implant Survival Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The percentage of implants that remain in place in the jaw.

  • Implant Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The percentage of implants that remain in place in the jaw.


Enrollment: 145
Study Start Date: October 2006
Study Completion Date: October 2013
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Submerged healing
The dental implants will be placed using a submerged healing treatment
Device: Straumann Bone Level Implant
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
Other Name: Straumann Bone Level Implant
Active Comparator: Trans-mucosal healing
The dental implants will be placed using a trans-mucosal healing treatment
Device: Straumann Bone Level Implant
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
Other Name: Straumann Bone Level Implant

Detailed Description:

The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Secondary Exclusion Criteria at Implant Surgery:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906425

Locations
United States, Florida
Dr. Jeffery Ganeles
Boca Raton, Florida, United States, 33431
Dr. William C. Martin
Gainesville, Florida, United States, 32610
Australia
Dr. Stephen T. Chen
Melbourne, Australia, 3123
Germany
Prof. Wiltfang
Kiel, Schleswig Holstein, Germany, 24105
Michael Gahlert
München, Germany, 80333
Katharinenhospital
Stuttgart, Germany, 70174
Private Universität Witten/ Herdecke
Witten/ Herdecke, Germany
Italy
Dr. Luca Cordaro
Rom, Italy, 00198
Spain
Prof. Mariano Sanz
Madrid, Spain, 28040
Sweden
Dr. Carl-Johan Ivanoff
Mölndal, Sweden, 43180
Switzerland
Christoph Hämmerle
Zurich, Switzerland, 8032
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Christoph Hammerle University of Zurich
  More Information

Publications:
Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00906425     History of Changes
Other Study ID Numbers: CR 05/05
Study First Received: May 19, 2009
Results First Received: June 6, 2012
Last Updated: February 21, 2014
Health Authority: Switzerland: Ethikkommission
Australia: Human Research Ethics Committee
United States: Institutional Review Board
Germany: Ethics Commission
Spain: Ethics Committee
Sweden: Institutional Review Board
Italy: Ethics Committee

Keywords provided by Institut Straumann AG:
Dental Implant

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on August 01, 2014