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

NCT03651908 | Completed DMC

• 1 other identifier: sravanthinovabone
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrabony Periodontal Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• clinical parameters - Changes in relative clinical attachment level

  Baseline and 9 months post surgery

Study Arms (2)

Interventional

EXPERIMENTAL

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

Interventional comparator

ACTIVE 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

Interventions

Conventional Flap Surgery PROCEDURE

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.

Interventional; Interventional comparator

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Study Sites (1)

Panineya institute of dental sciences and research center

Hyderabad, Telangana, 500060, India

Location

Related 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.

  PMID: 23633783 RESULT

• 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.

  PMID: 21513477 RESULT

Study Officials

• Veerendra nath Reddy, MDS

  Panineeya institute of dental sciences and research center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PG Student

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 29, 2018
• Study Start: September 5, 2017
• Primary Completion: September 23, 2018
• Study Completion: September 30, 2018
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)