SINUS LIFT 100% Anorganic Bovine Bone vs. 50% Anorganic Bovine Bone + 50% Autologous Bone

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants; Maxillary Sinus
• Intervention / Treatment: Device: 100% AAB; Device: 50% AAB plus 50% autologous bone

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • SS
    • Sassari, SS, Italy, 07100
      • Dipartimento di Scienze chirurgiche microchirurgiche e mediche dell'università degli studi di sassari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 100% AAB; Surgical procedures were performed according to a lateral approach technique at the edentulous region distal to the position of the first premolar. A mucoperiosteal buccal flap was elevated, exposing the lateral bony wall of the sinus antrum. A round diamond bur, 2 mm in diameter, was used to outline the demarcation of the lateral window, which was removed, thus completely exposing the underlying Schneiderian membrane. The membrane was separated from the housing bone, and a tension-free reflection exposing the sinus walls was achieved by gently pushing it away using a large flat curette (Kramer-Nevins, Hu-Friedy, Chicago, IL). The established voids were then filled with 100% AAB (Bio-Oss) followed by sealing the open lateral window by the placement of a collagen membrane (Bio Gide) and primary soft tissue closure using Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, Sint-Stevens-Woluwe, Belgium).	Device: 100% AAB; All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA). A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later. Both groups received tapered implants with an anodised surface.; Other Names: Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden); Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland
Active Comparator: 50% AAB plus 50% autologous bone; Surgical procedures were performed according to a lateral approach technique at the edentulous region distal to the position of the first premolar. A mucoperiosteal buccal flap was elevated, exposing the lateral bony wall of the sinus antrum. A round diamond bur, 2 mm in diameter, was used to outline the demarcation of the lateral window, which was removed, thus completely exposing the underlying Schneiderian membrane. The membrane was separated from the housing bone, and a tension-free reflection exposing the sinus walls was achieved by gently pushing it away using a large flat curette (Kramer-Nevins, Hu-Friedy, Chicago, IL). The established voids were then filled with 50% AAB (Bio-Oss) plus 50% autologous bone harvested locally with a bone scraper followed by sealing the open lateral window by the placement of a collagen membrane (Bio Gide) and primary soft tissue closure using Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, Sint-Stevens-Woluwe, Belgium).	Device: 50% AAB plus 50% autologous bone; All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA). A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later. Both groups received tapered implants with an anodised surface.; Other Names: Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden); Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IMPLANT SURVIVAL	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.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MARGINAL BONE LEVELS	Peri-implant marginal bone levels were evaluated on intraoral digital radiographs taken with the parallel technique. A blinded radiologist (FG), unaffiliated with the study centre, interpreted all radiographs. The distances from the mesial and distal interproximal bone to the reference point (the horizontal interface between the implant and abutment) were measured with a software tool (NIH Scion Image, ver. 4.0.2, Frederick, MD, USA) calibrated against the space between two threads to the nearest 0.1 mm, and the mean of these two measurements was calculated for each implant. The measurements were recorded with reference to the implant axis.	Baseline, 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MUCOSAL RESPONSE	Probing pocket depth (PPD) and bleeding on probing (BOP) were measured by a blinded operator (AD) with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing) at 6 and 12 months. Three vestibular and three lingual values were collected for each implant by the same dentist.	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari
• Investigators: Principal Investigator: Silvio M Meloni, DDS, Phd, MS, Università degli Studi di Sassari

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 19, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 19, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: Sinus lift