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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014