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Clinical Trials/NCT02170129
NCT02170129
Completed
Not Applicable

Sinus Lift Grafting With Anorganic Bovine Bone vs 50% Autologous + 50% Bovine Bone. One Year Results From a Randomized Controlled Trial.

Università degli Studi di Sassari1 site in 1 country16 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maxillary Sinus
Sponsor
Università degli Studi di Sassari
Enrollment
16
Locations
1
Primary Endpoint
IMPLANT SURVIVAL
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Background: Maxillary sinus floor augmentation is a standard surgical procedure to increase bone height in the atrophic posterior maxilla for dental implant placement. In bone reconstructive surgery, in general, autogenous bone is considered as the gold standard, primarily due to its osteogenic potential and remodelling capacity. Bone substitutes are available that can overcome the limitations of autologous bone due to their osteoconductive properties and biocompatibility. Several studies seem to validate these concepts, but further comparative trials are needed.

Aim: To compare the outcome of implants inserted in maxillary sinuses augmented with bovine bone grafts vs 50% bovine bone graft and 50% autologous bone according to a lateral approach.

Material and Methods: This study was designed as a randomised, controlled, clinical trial. Sixteen partially or fully edentulous patients, 20 sinuses, (four patients have been bilaterally treated) having 1 to 4 mm of residual crestal height below the maxillary sinuses were randomised according to a parallel group design. Sinuses were grafted according to a lateral approach. Group A (10 sinuses) was grafted with 50% anorganic bovine bone (Bio-Oss) and 50% autogenous bone, group B (10 sinuses) was grafted with 100% anorganic bovine bone (Bio-Oss). According with a two stages approach, after 7 months a total of 32 implants (Nobel Replace tapered groovy) were inserted with an insertion torque between 35 and 45 Ncm. At same surgical procedure a sample of bone was harvested for histomorphometric analysis . All implants were delayed loaded with screw retained temporary crowns 3 months after implants insertion and with screw retained definitive crowns 4 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, PPD and BOP. Clinical data were collected at baseline 6,12 months. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Università degli Studi di Sassari
Responsible Party
Principal Investigator
Principal Investigator

Silvio Mario Meloni

DDS, Phd, MS

Università degli Studi di Sassari

Eligibility Criteria

Inclusion Criteria

  • Need for implant-supported prosthesis in maxillary posterior area.
  • Need to insert implant in atrophic posterior maxilla, with a residual alveolar bone height 1 4 mm.
  • ≥ 18 years of age.
  • Provided written informed consent.
  • Smokers of fewer than 10 cigarettes per day.
  • Absence of sinus cyst or active sinusitis.

Exclusion Criteria

  • General contraindications to implant surgery.
  • Occluding dentition in the area intended for implant installation
  • Periodontitis.
  • Immunosuppression.
  • Previous history of irradiation of the head and neck area.
  • Uncontrolled diabetes.
  • Heavy smoker (\>10 cigarettes/day).
  • Poor oral hygiene.
  • Current or past treatment with bisphosphonates.
  • Substance abuse.

Outcomes

Primary Outcomes

IMPLANT SURVIVAL

Time Frame: up to 12 months

The removal of implants was dictated by instability, progressive marginal bone loss, infection, or implant fracture. The stability of individual implants was measured by the prosthodontist at the time of definitive crown delivery (5 months after implant placement) by applying 35 Ncm of removal torque. After 1 year, implant stability was tested manually with two dental mirror handles.

Secondary Outcomes

  • MARGINAL BONE LEVELS(Baseline, 12 months)

Study Sites (1)

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