Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00906425
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : August 31, 2012
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG

Tracking Information
First Submitted Date  ICMJE May 19, 2009
First Posted Date  ICMJE May 21, 2009
Results First Submitted Date  ICMJE June 6, 2012
Results First Posted Date  ICMJE August 31, 2012
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) [ Time Frame: Baseline and 6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
Change in interproximal bone level between 1st stage surgery and 6 months post-surgery [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00906425 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
  • Implant Survival Rate [ Time Frame: 6 months ]
    The percentage of implants that remain in place in the jaw.
  • Implant Survival Rate [ Time Frame: 12 months ]
    The percentage of implants that remain in place in the jaw.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2009)
  • Aesthetic outcome as recorded photographically [ Time Frame: 1, 2, 3, 4, and 5 years ]
  • Implant success and survival rates [ Time Frame: 6 months, 1, 2, 3, 4, and 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Jaw, Edentulous, Partially
Intervention  ICMJE Device: Straumann Bone Level Implant
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
Study Arms  ICMJE
  • Active Comparator: Submerged healing
    The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment
    Intervention: Device: Straumann Bone Level Implant
  • Active Comparator: Trans-mucosal healing
    The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment
    Intervention: Device: Straumann Bone Level Implant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2012)
145
Original Actual Enrollment  ICMJE
 (submitted: May 19, 2009)
146
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Italy,   Spain,   Sweden,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00906425
Other Study ID Numbers  ICMJE CR 05/05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut Straumann AG
Study Sponsor  ICMJE Institut Straumann AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christoph Hammerle University of Zurich
PRS Account Institut Straumann AG
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP