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

Completed · Not applicable

Conditions studied: Jaw, Edentulous, Partially

In brief

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

Key facts

Study ID

NCT00906425

Run by

Institut Straumann AG

People needed

145

Starts

2006-10-01

Expected to finish

2013-10-01

Last updated by the study team

2016-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• Dr. Jeffery Ganeles — Boca Raton, Florida, United States
• Dr. William C. Martin — Gainesville, Florida, United States
• Dr. Stephen T. Chen — Melbourne, Australia
• Prof. Wiltfang — Kiel, Schleswig-Holstein, Germany
• Michael Gahlert — München, Germany
• Katharinenhospital — Stuttgart, Germany
• Private Universität Witten/ Herdecke — Witten/ Herdecke, Germany
• Dr. Luca Cordaro — Rome, Italy
• Prof. Mariano Sanz — Madrid, Spain
• Dr. Carl-Johan Ivanoff — Mölndal, Sweden
• Christoph Hämmerle — Zurich, Switzerland

Full record on ClinicalTrials.gov

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