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

NCT02170129 | Completed

• 1 other identifier: SINUS LIFT
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Sinus; Dental Implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MARGINAL BONE LEVELS

  Baseline, 12 months

Other Outcomes (1)

• MUCOSAL RESPONSE

  Baseline, 12 months

Study Arms (2)

100% AAB

ACTIVE COMPARATOR

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

50% AAB plus 50% autologous bone

ACTIVE COMPARATOR

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

Interventions

50% AAB plus 50% autologous bone DEVICE

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.

Also known as: Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland, Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)

50% AAB plus 50% autologous bone

100% AAB DEVICE

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.

Also known as: Bioss, Geistlisch Pharma AG, Wolhusen, Switzerland, Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)

100% AAB

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Dipartimento di Scienze chirurgiche microchirurgiche e mediche dell'università degli studi di sassari

Sassari, SS, 07100, Italy

Location

Study Officials

• Silvio M Meloni, DDS, Phd, MS

  Università degli Studi di Sassari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Phd, MS

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 23, 2014
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

IT (1)