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Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

Primary Purpose

Jaw, Edentulous, Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Straumann BoneCeramic
Bio-Oss
Sponsored by
Institut Straumann AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw, Edentulous

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females, 18 years to 80 years of age
  • At least two missing teeth up to full edentulous arches.
  • Desiring implant supported restorations.
  • Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect).
  • At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone.
  • Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved;
  • Patients must be committed to the study and must sign informed consent.
  • Patient in good general health as documented by self assessment;
  • Full mouth plaque score of <20%;

Exclusion Criteria:

  • Any systemic medical condition that could interfere with the surgical procedure or planned treatment;
  • Current pregnancy or breast feeding/ lactating at the time of recruitment;
  • Physical handicaps that would interfere with the ability to perform adequate oral hygiene;
  • Alcoholism or chronically drug abuse causing systemic compromise.
  • Patients who smoke more than 20 cigarettes per day.
  • Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability
  • Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly.
  • Mucosal diseases such as erosive lichen planus
  • History of local radiation therapy.
  • Presence of osseous pathologies.
  • Presence of oral lesions (such as ulceration, malignancy)
  • Severe bruxing or clenching habits.
  • Local inflammation, including untreated periodontitis.
  • Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement.
  • Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease.
  • Existing teeth in the residual dentition with untreated endodontic pathologies.
  • Patients with inadequate oral hygiene or unmotivated for adequate home care

Sites / Locations

  • Katholieke Universiteit Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Straumann BoneCeramic

Bio-Oss

Arm Description

Straumann BoneCeramic

Geistlich Bio-Oss

Outcomes

Primary Outcome Measures

Change of Vertical Height of Buccal Defects
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery

Secondary Outcome Measures

Implant Success Rate
The success of oral implant will be determined according to the following parameters: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility (based on hand testing) Absence of a peri-implant infection with suppuration. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
Implant Success Rate
The success of oral implant will be determined according to the following parameters: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility (based on hand testing) Absence of a peri-implant infection with suppuration. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Implant Survival Rate
A surviving implant will be considered an implant fulfilling the following criteria: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.

Full Information

First Posted
May 11, 2009
Last Updated
March 2, 2016
Sponsor
Institut Straumann AG
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1. Study Identification

Unique Protocol Identification Number
NCT00901017
Brief Title
Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
Official Title
A Randomised Controlled Spilt-mouth Clinical Study Comparing a Synthetic Bone Substitute and a Bovine-derived Xenograft in Primarily Horizontal Bone Augmentation Procedure During Placement of Straumann Oral Implants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
August 2008 (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 objective of the study is to test the efficacy on bone formation of Straumann Bone Ceramic as a grafting material applied in buccal bone dehiscences on simultaneously placed oral implants.
Detailed Description
This is a randomized, controlled, split mouth, prospective, single centre study. The total study duration for each patient should be 76 weeks +/-18 months. In total 8 visits per patient are scheduled in this study. The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication. One center in Beligum will participate.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Straumann BoneCeramic
Arm Type
Active Comparator
Arm Description
Straumann BoneCeramic
Arm Title
Bio-Oss
Arm Type
Active Comparator
Arm Description
Geistlich Bio-Oss
Intervention Type
Device
Intervention Name(s)
Straumann BoneCeramic
Intervention Description
Bone augmentation procedure performed with Bone Ceramic
Intervention Type
Device
Intervention Name(s)
Bio-Oss
Intervention Description
Bone Augmentation procedure performed with Bio Oss
Primary Outcome Measure Information:
Title
Change of Vertical Height of Buccal Defects
Description
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
Time Frame
Baseline to 26 weeks
Secondary Outcome Measure Information:
Title
Implant Success Rate
Description
The success of oral implant will be determined according to the following parameters: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility (based on hand testing) Absence of a peri-implant infection with suppuration. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Time Frame
6 months
Title
Implant Survival Rate
Description
A surviving implant will be considered an implant fulfilling the following criteria: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
Time Frame
6 Months
Title
Implant Success Rate
Description
The success of oral implant will be determined according to the following parameters: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility (based on hand testing) Absence of a peri-implant infection with suppuration. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Bone level changes evaluated on periapical radiographs around implants less than 1 mm during the first year of loading, starting at abutment connection.
Time Frame
12 months
Title
Implant Survival Rate
Description
A surviving implant will be considered an implant fulfilling the following criteria: Absence of any continuous peri-implant radiolucency based on radiographic findings. Absence of implant mobility. Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics). Absence of pain or any other adverse observation by the patient, so that the implant has to be removed.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females, 18 years to 80 years of age At least two missing teeth up to full edentulous arches. Desiring implant supported restorations. Both study implants should have a self-containing (2-wall) buccal dehiscence defect after oral implant placement (at least 3.0 mm / max. 5.0 mm defect in apico-coronal aspect to be measured from the boarder of the rough surface of the oral implant to the bottom of the defect). At least 4mm of the implant, measured from the apical end to the lowest margin of the bone level, should be covered with bone. Sufficient bone volume such that both oral implants will not encroach on vital structures and primary stability of the oral implant can be achieved; Patients must be committed to the study and must sign informed consent. Patient in good general health as documented by self assessment; Full mouth plaque score of <20%; Exclusion Criteria: Any systemic medical condition that could interfere with the surgical procedure or planned treatment; Current pregnancy or breast feeding/ lactating at the time of recruitment; Physical handicaps that would interfere with the ability to perform adequate oral hygiene; Alcoholism or chronically drug abuse causing systemic compromise. Patients who smoke more than 20 cigarettes per day. Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability Lack of primary stability of 1 or both implant(s) at surgery, measured by hand testing. In this instance the patient must be withdrawn and treated accordingly. Mucosal diseases such as erosive lichen planus History of local radiation therapy. Presence of osseous pathologies. Presence of oral lesions (such as ulceration, malignancy) Severe bruxing or clenching habits. Local inflammation, including untreated periodontitis. Bone surgery at the implant site(s) (bone grafts, guided tissue regeneration techniques for bone enhancement) prior to implant placement unless performed more than 6 months prior to implant placement. Patients presenting clinical and radiological signs and symptoms of maxillary sinus disease. Existing teeth in the residual dentition with untreated endodontic pathologies. Patients with inadequate oral hygiene or unmotivated for adequate home care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Quirynen, Professor
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katholieke Universiteit Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

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