N/A
N=14
Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation
Jaw, Edentulous · Jaw, Edentulous, Partially
Bottom Line
View on ClinicalTrials.gov: NCT00901017 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Change of Vertical Height of Buccal Defects — -4.5; -4.82 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Straumann BoneCeramic (Device); Bio-Oss (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut Straumann AG
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Vertical Height of Buccal Defects |
-4.5; -4.82 | — |
| SECONDARY Implant Success Rate |
100; 100 | — |
| SECONDARY Implant Survival Rate |
100; 100 | — |
| SECONDARY Implant Success Rate |
100; 100 | — |
| SECONDARY Implant Survival Rate |
100; 100 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00901017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.