Evaluation of SilOss® in Periodontal Surgery

Summary

Siloss® (Azurebio, Madrid, Spain) is a synthetic and inorganic bone graft material and is composed of a dicalcium phosphate anhydrous (monetite), hydroxyapatite (HA), and amorphous silica and trace amounts of zinc. It is manufactured by a proprietary process avoiding high temperatures. This results in a non-sintered material with a high specific surface area (65 m2/g) and high interconnected porosity (60%) that favour a high degree of interaction with its biological surrounding. It is fully resorbable, being replaced by natural bone, thereby avoiding the disadvantages of nonresorbable materials that interfere with normal processes of bone remodelling. Siloss® is resorbed both by a dual process of slow dissolution of its components and by active cellular remodelling. Controlled dissolution of Siloss® releases Ca, P, Si and Zn that stimulate regeneration processes while larger pores are formed allowing colonization of osteoclasts and osteoblasts involved in bone remodelling. It functions as a bioactive temporary scaffold maintaining the desired volume while it promotes bone regeneration and is being replaced by new vascularized bone. The alloplastic property of the graft material avoids the risk of infection and adverse inflammatory reactions. Also, resorption of Siloss® prevents possible adverse effects associated with long permanence of low resorbable materials.

The aim of the present study is to clinically and radiographically evaluate the efficacy of bone graft material (Siloss ®) in the treatment of intrabony defects.

Conditions

• Chronic Periodontitis

Interventions

BIOLOGICAL

Siloss® bone graft

The osseous defect was debrided of granulation tissue and the root surface was planed to remove plaque and calculus, until a smooth hard consistency was found. The defect's architecture was confirmed by direct observation and classified based on number of bony walls present. In patients selected for test group, in addition to open flap debridement (OFD), Siloss® bone replacement graft was utilized to fill the defects to the most coronal level of the osseous walls. The required amount of composite alloplast (Siloss®) was dispensed into a sterile dappen dish and mixed with patients own blood and carried to the defect site with an amalgam carrier. The mucoperiosteal flaps were repositioned and secured in place using interrupted sutures. The surgical procedure in control site included open flap debridement followed by placement of hydroxyapatite graft (G-graft®, Saharanpur, UP, India). The surgical area was protected and covered using a periodontal dressing. Randomization was employed.

BIOLOGICAL

Hydroxyapatitie Bone graft

The osseous defect was debrided of granulation tissue and the root surface was planed to remove plaque and calculus, until a smooth hard consistency was found. The defect's architecture was confirmed by direct observation and classified based on number of bony walls present. In patients selected for test group, in addition to open flap debridement (OFD), Siloss® bone replacement graft was utilized to fill the defects to the most coronal level of the osseous walls. The required amount of composite alloplast (Siloss®) was dispensed into a sterile dappen dish and mixed with patients own blood and carried to the defect site with an amalgam carrier. The mucoperiosteal flaps were repositioned and secured in place using interrupted sutures. The surgical procedure in control site included open flap debridement followed by placement of hydroxyapatite graft (G-graft®, Saharanpur, UP, India). The surgical area was protected and covered using a periodontal dressing.Randomization was employed.

Sponsors & Collaborators

• AzureBio, Madrid, Soain

  collaborator UNKNOWN

• SVS Institute of Dental Sciences

  lead OTHER

Principal Investigators

• Rampalli V Chandra, MDS;DNB · IEC, SVSIDS, Mahabubnagar

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2014-08-31

Completion

2014-12-31

Countries

• India