Clinical trial NCT02170129: SINUS LIFT 100% Anorganic Bovine Bone vs. 50% Anorganic Bovine Bone + 50% Autologous Bone
Official title: Sinus Lift Grafting With Anorganic Bovine Bone vs 50% Autologous + 50% Bovine Bone. One Year Results From a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus
Dental Implants
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Bruxism.
* 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.
* Psychiatric disorder.
* Inability to complete follow-up ≥1 year.
* Lactation.

Primary outcomes:
measure: IMPLANT SURVIVAL
timeFrame: up to 12 months
Secondary outcomes:
measure: MARGINAL BONE LEVELS
timeFrame: Baseline, 12 months
Other outcomes:
measure: MUCOSAL RESPONSE
timeFrame: Baseline, 12 months
Locations:
city: Sassari
country: Italy
facility: Dipartimento di Scienze chirurgiche microchirurgiche e mediche dell'università degli studi di sassari
state: SS
Study officials:
affiliation: Università degli Studi di Sassari
name: Silvio M Meloni, DDS, Phd, MS
role: PRINCIPAL_INVESTIGATOR
References: