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

Primary Purpose

Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Straumann Bone Level Implant
Sponsored by
Institut Straumann AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous, Partially focused on measuring Dental Implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Jeffery Ganeles
  • Dr. William C. Martin
  • Dr. Stephen T. Chen
  • Prof. Wiltfang
  • Michael Gahlert
  • Katharinenhospital
  • Private Universität Witten/ Herdecke
  • Dr. Luca Cordaro
  • Prof. Mariano Sanz
  • Dr. Carl-Johan Ivanoff
  • Christoph Hämmerle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Submerged healing

Trans-mucosal healing

Arm Description

The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment

The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Implant Survival Rate
The percentage of implants that remain in place in the jaw.
Implant Survival Rate
The percentage of implants that remain in place in the jaw.

Full Information

First Posted
May 19, 2009
Last Updated
March 2, 2016
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT00906425
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw, Edentulous, Partially
Keywords
Dental Implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Submerged healing
Arm Type
Active Comparator
Arm Description
The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment
Arm Title
Trans-mucosal healing
Arm Type
Active Comparator
Arm Description
The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment
Intervention Type
Device
Intervention Name(s)
Straumann Bone Level Implant
Intervention Description
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm
Primary Outcome Measure Information:
Title
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)
Description
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.
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Implant Survival Rate
Description
The percentage of implants that remain in place in the jaw.
Time Frame
6 months
Title
Implant Survival Rate
Description
The percentage of implants that remain in place in the jaw.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Hammerle
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Jeffery Ganeles
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Dr. William C. Martin
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Dr. Stephen T. Chen
City
Melbourne
ZIP/Postal Code
3123
Country
Australia
Facility Name
Prof. Wiltfang
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Michael Gahlert
City
München
ZIP/Postal Code
80333
Country
Germany
Facility Name
Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Private Universität Witten/ Herdecke
City
Witten/ Herdecke
Country
Germany
Facility Name
Dr. Luca Cordaro
City
Rom
ZIP/Postal Code
00198
Country
Italy
Facility Name
Prof. Mariano Sanz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Dr. Carl-Johan Ivanoff
City
Mölndal
ZIP/Postal Code
43180
Country
Sweden
Facility Name
Christoph Hämmerle
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21722188
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.
Results Reference
result
PubMed Identifier
22697581
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.
Results Reference
result

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

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