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

Sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre (Other)

Overall Status

Completed

CT.gov ID

NCT03651908

Collaborator

(none)

Enrollment

Location

Arms

12.8

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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	N/A

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

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.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 :

Sep 5, 2017

Actual Primary Completion Date :

Sep 23, 2018

Actual Study Completion Date :

Sep 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.

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

Outcome Measures

Primary Outcome Measures

Radiographic parameters - Change in bone level [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

clinical parameters - Changes in relative clinical attachment level [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

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Aug 29, 2018

Last Update Posted:

Jan 25, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 25, 2019