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N/A N=14 Randomized Treatment

Comparison of Synthetic Bone Substitute and a Bovine-derived Xenograft in Horizontal Bone Augmentation

Jaw, Edentulous · Jaw, Edentulous, Partially

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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