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Evaluation of SilOss® in Periodontal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639572
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Collaborator:
AzureBio, Madrid, Soain
Information provided by (Responsible Party):
Dr R Viswa Chandra, SVS Institute of Dental Sciences

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Biological: Siloss® bone graft Biological: Hydroxyapatitie Bone graft Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of a Novel Synthetic Bone Regeneration Material (Sil-Oss®) In the Treatment of Periodontal Intrabony Osseous Defects
Study Start Date : January 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: Siloss® bone graft
Based on the sequence, in the test site,Siloss® was placed.
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.

Placebo Comparator: Hydroxyapatitie Bone graf
Based on the sequence, the control site which was treated by Hydroxyapatite graft only.
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.




Primary Outcome Measures :
  1. Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL) [ Time Frame: 9 months ]
    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.

  2. Digital subtraction technique and Morphometric Analysis [ Time Frame: 6 months ]
    The radiographs obtained at 3 and 6 months were subtracted from the radiograph taken at the baseline by using commercially available image processing software


Secondary Outcome Measures :
  1. Quantifying the Mineralized Tissue Volume [ Time Frame: 7 to 9 months ]
    From 3 subjects each from both the groups, bone biopsy specimens were obtained during crown lengthening procedures between 71/2 to 9 months. Briefly, the specimens were immersed in 4% buffered formalin and were subsequently dehydrated in an ascending series of ethyl alcohols. The specimens were then stained using haematoxylin-eosin for light microscopy analysis. 11 and 12 slides were prepared from SILOSS® and HA groups respectively. 10 regions of interest (ROIs) per slide were visualized for mineralized tissue volume by using an Olympus BX 53 microscope at 40X magnification. Before evaluation of bone sections in ImageJ, black and white image masks were created using Adobe Photoshop® according to a technique described by Egan et al.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639572


Locations
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India
SVS Institute of Dental Sciences, Mahabubnagar
Hyderabad, Andhra Pradesh, India, 509002
Sponsors and Collaborators
SVS Institute of Dental Sciences
AzureBio, Madrid, Soain
Investigators
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Principal Investigator: Rampalli V Chandra, MDS;DNB IEC, SVSIDS, Mahabubnagar

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Responsible Party: Dr R Viswa Chandra, Professor and Head, Periodontics, SVSIDS, Mahabubnagar, SVS Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT02639572    
Other Study ID Numbers: SVSIDS/PERIO/1/2014
Reg.no. D139406039 ( Other Identifier: Dr NTR University of Health Sciences, Vijayawada, India )
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared after publishing the results
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases