Horizontal Ridge Augmentation Using One-stage Guided Bone Regeneration (GBR) for Bone Defect Class IV of Cawed and Howell With Collagene Membrane (OssMem) and a Mix of Bovine Bone Substitute (A-Oss) and Autogenous Bone Versus A-Oss and LCR-A, a Synthetic Bone : a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Guided Bone Regeneration
- Sponsor
- Università degli Studi di Sassari
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Number of Participants with prosthesis failure
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of this randomized controlled trial is to evaluate the tridimensional bone stability after horizontal one-stage GBR using collagene membrane (OssMem) with a mix of Bovine Bone Substitute (A-Oss) and autogenous bone (test group) versus A-Oss and LCR-A, a synthetic bone (control group).
Investigators
Marco Tallarico
Aisstent Professor
Università degli Studi di Sassari
Eligibility Criteria
Inclusion Criteria
- •Patients that required an implant supported restoration and staged horizontal guided bone regeneration (defect of class IV according to Cawed and Howell) in both mandible or maxilla.
- •Patents able to understand and sign an informed consent.
- •Patients were to be 18 years or older with a residual horizontal ridge thickness of 4 mm or less (Cawood-Howell Class III- IV) in the intended implant site.
- •Smokers will be categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Only categories 1 and 2 will be included.
Exclusion Criteria
- •General contraindications to implant surgery.
- •Patients irradiated in the head and neck area.
- •Immunosuppressed or immunocompromised patients.
- •Patients treated or under treatment with intravenous amino-bisphosphonates.
- •Patients with untreated periodontitis.
- •Patients with poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Pregnancy or nursing.
- •Substance abuser.
- •Heavy smokers (smoking more than 11 cigarettes/day).
Outcomes
Primary Outcomes
Number of Participants with prosthesis failure
Time Frame: Up to 5 years
Whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason.
Rate of Implants survival
Time Frame: Up to 5 years
Defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable. The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments
Number of complications
Time Frame: Up to 5 years
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, mobility, membrane exposure, suppuration) complications will be considered
Secondary Outcomes
- Horizontal and volumetric dimensional changes(6 and 12 months)
- Valuation of soft tissue thickness and amount of keratinized tissue(At 1,3 and 5 years)
- Rate of pes score(At 1,3 and 5 years)
- Rate of peri-implant marginal bone level(At 1,3 and 5 years)
- Valuation of patient satisfaction(At 1,3 and 5 years)
- Plaque Index and bleeping on probing(At 1,3 and 5 years)