Clinical trial NCT00906425: Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Keywords: Dental Implant
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2009-05-21
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Implant Survival Rate
timeFrame: 6 months
measure: Implant Survival Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Dr. Jeffery Ganeles
state: Florida
city: Gainesville
country: United States
facility: Dr. William C. Martin
state: Florida
city: Melbourne
country: Australia
facility: Dr. Stephen T. Chen
city: Kiel
country: Germany
facility: Prof. Wiltfang
state: Schleswig Holstein
city: München
country: Germany
facility: Michael Gahlert
city: Stuttgart
country: Germany
facility: Katharinenhospital
city: Witten/ Herdecke
country: Germany
facility: Private Universität Witten/ Herdecke
city: Rom
country: Italy
facility: Dr. Luca Cordaro
city: Madrid
country: Spain
facility: Prof. Mariano Sanz
city: Mölndal
country: Sweden
facility: Dr. Carl-Johan Ivanoff
city: Zurich
country: Switzerland
facility: Christoph Hämmerle
Study officials:
affiliation: University of Zurich
name: Christoph Hammerle
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.