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Clinical Trials/NCT04767243
NCT04767243
Completed
Phase 4

Regenerative Potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) Bone Graft in the Treatment of Intrabony Defects; A Comparative Clinico Radiographic Study.

Maharishi Markendeswar University (Deemed to be University)1 site in 1 country48 target enrollmentDecember 1, 2020

Overview

Phase
Phase 4
Intervention
open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)
Conditions
Chronic Periodontitis
Sponsor
Maharishi Markendeswar University (Deemed to be University)
Enrollment
48
Locations
1
Primary Endpoint
probing depth
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study is to evaluate and compare the regenerative potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) bone graft in the treatment of intrabony defects in chronic periodontitis patients.

Detailed Description

45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III. * Group I will be treated with open flap debridement and filled with A-PRF * Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®) * Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
March 4, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible Party
Principal Investigator
Principal Investigator

DR SURINDER SACHDEVA

PROFESSOR

Maharishi Markendeswar University (Deemed to be University)

Eligibility Criteria

Inclusion Criteria

  • Age: 25 to 55 years.
  • Gender: Both males and females will be included in the study.
  • Co-operative and motivated patients committed to oral hygiene.
  • Patients exhibiting intrabony defects.

Exclusion Criteria

  • Patients with contraindication to periodontal surgery \& local anesthesia.
  • Any systemic disease affecting the bone density and outcome of periodontal therapy.
  • Smokers, alcoholics, and patients with other adverse habits.
  • Pregnant, nursing and menopausal women.
  • Any known allergy/ hypersensitivity to any product used in this study.
  • Patients on long-term systemic therapy (antibiotics, anti-inflammatory bisphosphonates, hormonal replacement therapy and any other), taking any drug known to have periodontal implications that may interfere with wound healing.
  • Patients taking any anti-platelet and anticoagulant medication.
  • Patients who have undergone periodontal treatment within a period of past 1 year.

Arms & Interventions

open flap debridement and filled with A-PRF

After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.

Intervention: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)

open flap debridement and filled with Bioactive glass (Perioglas®)

After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.

Intervention: open flap debridement and filled with Bioactive glass (Perioglas®)

with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.

After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) along with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.

Intervention: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF

Outcomes

Primary Outcomes

probing depth

Time Frame: baseline, 3 months, 6 months

change in probing pocket depth

relative attachment level

Time Frame: baseline, 3 months, 6 months

change in attachment level

radiographic linear bone change

Time Frame: change from baseline to 6 months

radiographic linear bone change through radiographic grid

Secondary Outcomes

  • Plaque index site specific(baseline, 3 months, 6 months)
  • Gingival index site specific(baseline, 3 months, 6 months)

Study Sites (1)

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