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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Submerged healing	Straumann Bone Level Implant	The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment
Trans-mucosal healing	Straumann Bone Level Implant	The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment

Primary Outcome Measures

Name	Time	Method
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)	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.

Secondary Outcome Measures

Name	Time	Method
Implant Survival Rate	12 months	The percentage of implants that remain in place in the jaw.

Locations (11): Dr. Carl-Johan Ivanoff
🇸🇪
Mölndal, Sweden
Prof. Wiltfang
🇩🇪
Kiel, Schleswig Holstein, Germany
Michael Gahlert
🇩🇪
München, Germany
Katharinenhospital
🇩🇪
Stuttgart, Germany
Dr. Luca Cordaro
🇮🇹
Rom, Italy
Private Universität Witten/ Herdecke
🇩🇪
Witten/ Herdecke, Germany
Prof. Mariano Sanz
🇪🇸
Madrid, Spain
Dr. Jeffery Ganeles
🇺🇸
Boca Raton, Florida, United States
Dr. William C. Martin
🇺🇸
Gainesville, Florida, United States
Dr. Stephen T. Chen
🇦🇺
Melbourne, Australia
Christoph Hämmerle
🇨🇭
Zurich, Switzerland