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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03651908
Acronym
CBBSGPPOPIDWD
Enrollment
14
Registered
2018-08-29
Start date
2017-09-05
Completion date
2018-09-30
Last updated
2019-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrabony Periodontal Defect

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.

Interventions

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.

Sponsors

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Sealed envelopes

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.

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Radiographic parameters - Change in bone levelBaseline 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

MeasureTime frameDescription
clinical parameters - Changes in relative clinical attachment levelBaseline and 9 months post surgeryChanges in relative clinical attachment level will be measured by UNC -15 probe in millimeters in the intrabony defect area

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026