Status:
COMPLETED
Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
Lead Sponsor:
Institut Straumann AG
Conditions:
Jaw, Edentulous
Jaw, Edentulous, Partially
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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 In this instance the patient must be withdrawn and treated accordingly.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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00901017
Start Date
March 1 2006
End Date
August 1 2008
Last Update
March 30 2016
Active Locations (1)
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1
Katholieke Universiteit Leuven
Leuven, Belgium, 3000