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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Straumann AG
ClinicalTrials.gov Identifier:
NCT00901017
First received: May 11, 2009
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Jaw, Edentulous
Jaw, Edentulous, Partially
Device: Straumann BoneCeramic
Device: Bio-Oss

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Institut Straumann AG:

Primary Outcome Measures:
  • Change of Vertical Height of Buccal Defects [ Time Frame: Baseline to 26 weeks ] [ Designated as safety issue: No ]
    Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery


Secondary Outcome Measures:
  • Implant Success Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


Enrollment: 14
Study Start Date: March 2006
Study Completion Date: August 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Straumann BoneCeramic
Straumann BoneCeramic
Device: Straumann BoneCeramic
Bone augmentation procedure performed with Bone Ceramic
Active Comparator: Bio-Oss
Geistlich Bio-Oss
Device: Bio-Oss
Bone Augmentation procedure performed with Bio Oss

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00901017

Locations
Belgium
Katholieke Universiteit Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Institut Straumann AG
Investigators
Principal Investigator: Marc Quirynen, Professor Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: Institut Straumann AG
ClinicalTrials.gov Identifier: NCT00901017     History of Changes
Other Study ID Numbers: CR 04/05
Study First Received: May 11, 2009
Results First Received: August 30, 2012
Last Updated: October 4, 2012
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on April 17, 2014