Clinical trial NCT03651908: Comparison Between Bioactive Silica Graft Plus Platelet Rich Fibrin and Only Platelet Rich Fibrin Graft in Intrabony Defects With Diabetes
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrabony Periodontal Defect
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Radiographic parameters - Change in bone level
timeFrame: Baseline and 9 months post surgery.
Secondary outcomes:
measure: clinical parameters - Changes in relative clinical attachment level
timeFrame: Baseline and 9 months post surgery
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Panineya institute of dental sciences and research center
state: Telangana
Study officials:
affiliation: Panineeya institute of dental sciences and research center
name: Veerendra nath Reddy, MDS
role: STUDY_DIRECTOR
References:
citation: 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.
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 2011 Apr 5.