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

Jaw, Edentulous, Partially Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906425
• Other study ID #: CR 05/05
• Status: Completed
• Phase: N/A
• First received: May 19, 2009
• Last updated: February 21, 2014
• Start date: October 2006
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: Institut Straumann AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionAustralia: Human Research Ethics CommitteeUnited States: Institutional Review BoardGermany: Ethics CommissionSpain: Ethics CommitteeSweden: Institutional Review BoardItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 2013
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Device:
• Straumann Bone Level Implant
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Institut Straumann AG

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Italy,  Spain,  Sweden,  Switzerland, 

References & Publications (2)

Cordaro L, Torsello F, Chen S, Ganeles J, Brägger U, Hämmerle 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 — View Citation

Hämmerle CH, Jung RE, Sanz M, Chen S, Martin WC, Jackowski J; Multicenter study group. 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)	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.	Baseline and 6 months	No
Secondary	Implant Survival Rate	The percentage of implants that remain in place in the jaw.	6 months	No
Secondary	Implant Survival Rate	The percentage of implants that remain in place in the jaw.	12 months	Yes