Regenerative Potential of Advanced Platelet Rich Fibrin and Bioactive Glass (Perioglas®).

November 5, 2022 updated by: DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Ambāla, Haryana, India, 133207
        • Department of Periodontology, M.M. College of Dental Sciences and Research.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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.
Procedure: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)
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.
Active Comparator: 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.
Procedure: 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 perioglas in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
Other Names:
  • perioglas
Active Comparator: 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.
Drug: 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 perioglas with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
Other Names:
  • perioglas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
probing depth
Time Frame: baseline, 3 months, 6 months
change in probing pocket depth
baseline, 3 months, 6 months
relative attachment level
Time Frame: baseline, 3 months, 6 months
change in attachment level
baseline, 3 months, 6 months
radiographic linear bone change
Time Frame: change from baseline to 6 months
radiographic linear bone change through radiographic grid
change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index site specific
Time Frame: baseline, 3 months, 6 months
Plaque index -Silness and Loe
baseline, 3 months, 6 months
Gingival index site specific
Time Frame: baseline, 3 months, 6 months
Gingival index- Loe and Silness
baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maharishi Markendeswar University (Deemed to be University)

Investigators

  • Principal Investigator: surinder sachdeva, M.D.S., professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

February 18, 2022

Study Completion (Actual)

March 4, 2022

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 20, 2021

First Posted (Actual)

February 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 5, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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