Comparison Between Bioactive Silica Graft Plus Platelet Rich Fibrin and Only Platelet Rich Fibrin Graft in Intrabony Defects With Diabetes (CBBSGPPOPIDWD)

• ClinicalTrials.gov Identifier: NCT03651908
• Recruitment Status: Completed
• First Posted: August 29, 2018
• Last Update Posted: January 25, 2019
• Sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Information provided by (Responsible Party): Dr. V. Sravanthi, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Study Description

Brief Summary:

Various regenerative procedures used for the treatment of intabony defects.The Aim of this study is to compare the treatment outcome of bioactive silica graft with platelet rich fibrin Vs bioactive silica graft in the treatment of intrabony defects in patients with diabetes mellitus.

Condition or disease	Intervention/treatment	Phase
Intrabony Periodontal Defect	Procedure: Conventional Flap Surgery	Not Applicable

Detailed Description:

Platelet rich fibrin has emerged as one of the promising regenerative material.It is a second generation platelet concentrate and is defined as an autologous leucocyte-and platelet-rich fibrin biomaterial.Platelet-rich fibrin membrane consists of a fibrin 3-D polymerized matrix in a specific structure ,with the incorporation of almost all the platelets and more than half of leucocytes along with growth factors.It enhance the stabilization and revascularization of the flaps and grafts.

Bioactive silica graft (Novabone dental putty )is being used for regenerative procedures is a premixed composite of bioactive calcium -phospho-silicate particulate which is composed solely of elements that exist naturally in normal bone (ca,p,na,si,o) and an absorbable binder which is a combination of polyethylene glycol and glycerine.Treatment of intrabony defects with bioactive silica graft has led to clinically and statistically significant probing depth reduction ,relative attachment level gain and radiographic osseous defect fill.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

In this study the patients are divided into two test groups-group A, group B. Each patient will be given careful instructions on proper oral hygiene measures. Under local anesthesia full-mouth supragingival and subgingival scaling and root planning procedure will be performed. After therapy, a periodontal evaluation will be done and the selected sites will be divided into group A and group B.

The Group A subjects will be treated with conventional flap surgery using Bioactive silica graft with PRF as a graft.

Group B will be treated with conventional flap surgery +bioactive silica graft alone in intrabony defects.

• Masking: Single (Participant)
• Masking Description: Sealed envelopes
• Primary Purpose: Treatment
• Official Title: Evaluation of Efficacy of Bioactive Silica Graft With Platelet Rich Fibrin Vs Bioactive Silica Graft Alone In The Treatment Of Intrabony Defects In Patients With Type II Diabetes Mellitus -A Randomized Clinical Study.
• Actual Study Start Date: September 5, 2017
• Actual Primary Completion Date: September 23, 2018
• Actual Study Completion Date: September 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Interventional; Interventional The Group A subjects will be treated with conventional flap surgery.After reflection of the full thickness flap,the intrabony defects will be debrided and Bioactive silicate graft mixed with PRF will be used as graft material to fill the defects.	Procedure: Conventional Flap Surgery; After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back.
Active Comparator: Interventional comparator; Group B patients will also be treated by conventional flap surgery,employing a full thickness flap technique.The intrabony defects will be filled with Bioactive silicate only.	Procedure: Conventional Flap Surgery; After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back. After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back.

Outcome Measures

Primary Outcome Measures :

1. Radiographic parameters - Change in bone level [ Time Frame: Baseline and 9 months post surgery. ]
   Amount of bone fill in the intrabony defect (Change in bone level) to be measured by Cone Beam Computed Tomography (CBCT)

Secondary Outcome Measures :

1. clinical parameters - Changes in relative clinical attachment level [ Time Frame: Baseline and 9 months post surgery ]
   Changes in relative clinical attachment level will be measured by UNC -15 probe in millimeters in the intrabony defect area

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Two or three walled defects With relative clinical attachment loss ≥3mm Probing depth≥5mm Patients with known diabetes(Type 2 hbA1c 6 to 7.4)

Exclusion Criteria:

• One wall defects Other systemically compromised patients Non- compliant patients Individuals allergic to medication Pregnant or lactating mothers Smokers

Contacts and Locations

Locations

India

Panineya institute of dental sciences and research center

Hyderabad, Telangana, India, 500060

Sponsors and Collaborators

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Investigators

• Study Director: Veerendra nath Reddy, MDS; Panineeya institute of dental sciences and research center

More Information

Publications of Results:

Grover V, Kapoor A, Malhotra R, Uppal RS. Evaluation of the efficacy of a bioactive synthetic graft material in the treatment of intrabony periodontal defects. J Indian Soc Periodontol. 2013 Jan;17(1):104-10. doi: 10.4103/0972-124X.107484.

Sharma A, Pradeep AR. Treatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: a randomized controlled clinical trial. J Periodontol. 2011 Dec;82(12):1705-12. doi: 10.1902/jop.2011.110075. Epub 2011 Apr 5.

• Responsible Party: Dr. V. Sravanthi, PG Student, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• ClinicalTrials.gov Identifier: NCT03651908
• Other Study ID Numbers: sravanthinovabone
• First Posted: August 29, 2018
• Last Update Posted: January 25, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No