Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
This study has been completed.
Sponsor:
Institut Straumann AG
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
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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
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 May 23, 2013