Evaluation of SilOss® in Periodontal Surgery

NCT02639572 | Completed Phase 2 DMC

• 2 other identifiers: SVSIDS/PERIO/1/2014Reg.no. D139406039
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL)

  PPD and CAL were recorded at the baseline and at the end of 3, 6 and 9 months using a UNC-15 color-coded periodontal probe. An alginate impression was taken and custom acrylic stent limited to the occlusal 2/3rds of the clinical crown were used as fixed reference position (i.e. junction of vertical groove and lower border of the stent). A groove was prepared in the stent to standardize the probing angulation throughout the study period.

  9 months

• Digital subtraction technique and Morphometric Analysis

  The radiographs obtained at 3 and 6 months were subtracted from the radiograph taken at the baseline by using commercially available image processing software

  6 months

Secondary Outcomes (1)

• Quantifying the Mineralized Tissue Volume

  7 to 9 months

Study Arms (2)

Siloss® bone graft

EXPERIMENTAL

Based on the sequence, in the test site,Siloss® was placed.

Biological: Siloss® bone graft

Hydroxyapatitie Bone graf

PLACEBO COMPARATOR

Based on the sequence, the control site which was treated by Hydroxyapatite graft only.

Biological: Hydroxyapatitie Bone graft

Interventions

Siloss® bone graft BIOLOGICAL

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.

Siloss® bone graft

Hydroxyapatitie Bone graft BIOLOGICAL

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.

Hydroxyapatitie Bone graf

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• having at least 2 periodontal pockets ≥5 mm with at least 1 pocket in each quadrant showing radiographic evidence of vertical bone loss were included in the study.

You may not qualify if:

• Patients who underwent periodontal therapy in the past 6 months and/or have used antibiotic drugs, antioxidants, and antibacterial mouthwash or medicated toothpastes within 6 months of baseline and smokers were excluded from the study.

Sponsors & Collaborators

• SVS Institute of Dental Sciences: lead
• AzureBio, Madrid, Soain: collaborator

Study Sites (1)

SVS Institute of Dental Sciences, Mahabubnagar

Hyderabad, Andhra Pradesh, 509002, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rampalli V Chandra, MDS;DNB

  IEC, SVSIDS, Mahabubnagar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Periodontics, SVSIDS, Mahabubnagar

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: December 24, 2015
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 24, 2015

Record last verified: 2014-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)