NCT05079542
Active, not recruiting
Not Applicable
Randomized Controlled Clinical Trial of BLT Implants Used for Immediate vs Early Placement and Restored With Lithium-disilicate Glass Ceramic or Sintered Zirconia Crowns on Titanium Bonding Bases.
University of Geneva, Switzerland0 sites60 target enrollmentOctober 5, 2015
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tooth Loss
- Sponsor
- University of Geneva, Switzerland
- Enrollment
- 60
- Primary Endpoint
- Implant survival
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to assess the outcome of a new bone level tapered implant when inserted either following an immediate placement protocol or an early placement approach and restored with single crowns out of two different ceramic materials adhesively cemented on a titanium bonding base.
Investigators
Dr. med. dent. Malin Strasding
Principal Investigator
University of Geneva, Switzerland
Eligibility Criteria
Inclusion Criteria
- •Subjects must require extraction and replacement of a tooth in the maxillary or mandibular anterior or premolar region with an implant reconstruction.
- •≥22 years of age
- •Patient in a good general health
- •Adequate bone quality and quantity for one-stage implant placement
- •Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5)
- •Adequate bone height of at least 1mm longer than the length of the study implant
- •Capable of providing written informed consent.
- •Obtained informed consent from the patient and committed to the study and the required follow-up visits.
Exclusion Criteria
- •Patients with a high lip line / smile line
- •Thin mucosal biotype
- •Anatomically not sufficient bone volume or height at implant site to achieve primary stability of the implant
- •Pronounced esthetic expectations
- •Lack of keratinized mucosa at implant site (\< 2mm oral and buccal)
- •Women of childbearing potential with a positive urine pregnancy test
- •Patients with inadequate oral hygiene or persistent intraoral infection
- •Smokers exceeding 10 cigarettes / day, or equivalent; patients chewing tobacco
- •Severe bruxism or clenching habits
- •Presence a systemic disease or allergy (e.g. conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids, history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.)
Outcomes
Primary Outcomes
Implant survival
Time Frame: 5 years
Survival of the implant
Survival of the reconstructions
Time Frame: 5 years
Survival of prosthetic reconstruction
Secondary Outcomes
- Mesial and distal bone levels(5 years)
- ISQ values(3 months)
- Soft tissue volume(5 years)
- Technical and biological outcomes of the restorations(5 years)
- Recording the need of GBR procedures(8 weeks)
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