NCT00901017CompletedNot Applicable
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
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Institut Straumann AG
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change of Vertical Height of Buccal Defects
Study Overview
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 in this study.
The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA. The products are used within the indication.
One center in Beligum will participate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Straumann BoneCeramic
Active Comparator
Straumann BoneCeramic
Intervention: Straumann BoneCeramic (Device)
Bio-Oss
Active Comparator
Geistlich Bio-Oss
Intervention: Bio-Oss (Device)
Outcomes
Primary Outcomes
Change of Vertical Height of Buccal Defects
Time Frame: Baseline to 26 weeks
Change of vertical height of buccal defects over 26 weeks, measured during 1st - and 2nd- stage surgery
Secondary Outcomes
- Implant Success Rate(12 months)
- Implant Survival Rate(12 months)
- Implant Success Rate(6 months)
- Implant Survival Rate(6 Months)
Investigators
Study Sites (1)
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