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

Intrabony Periodontal Defect Clinical Trial

— CBBSGPPOPIDWD  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651908
• Other study ID #: sravanthinovabone
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: January 2019
• Source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: September 30, 2018
• Est. primary completion date: September 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrabony Periodontal Defect

Intervention

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.

Locations

Country	Name	City	State
India	Panineya institute of dental sciences and research center	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic parameters - Change in bone level	Amount of bone fill in the intrabony defect (Change in bone level) to be measured by Cone Beam Computed Tomography (CBCT)	Baseline and 9 months post surgery.
Secondary	clinical parameters - Changes in relative clinical attachment level	Changes in relative clinical attachment level will be measured by UNC -15 probe in millimeters in the intrabony defect area	Baseline and 9 months post surgery