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

Primary Purpose

Chronic Periodontitis, Bone Loss, Intrabony Periodontal Defect

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)
open flap debridement and filled with Bioactive glass (Perioglas®)
open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring intrabony periodontal defect, regeneration, platelet rich fibrin, bioactive glass

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Periodontology, M.M. College of Dental Sciences and Research.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

open flap debridement and filled with A-PRF

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

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

probing depth
change in probing pocket depth
relative attachment level
change in attachment level
radiographic linear bone change
radiographic linear bone change through radiographic grid

Secondary Outcome Measures

Plaque index site specific
Plaque index -Silness and Loe
Gingival index site specific
Gingival index- Loe and Silness

Full Information

First Posted
February 9, 2021
Last Updated
November 5, 2022
Sponsor
Maharishi Markendeswar University (Deemed to be University)
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1. Study Identification

Unique Protocol Identification Number
NCT04767243
Brief Title
Regenerative Potential of Advanced Platelet Rich Fibrin and Bioactive Glass (Perioglas®).
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 18, 2022 (Actual)
Study Completion Date
March 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Bone Loss, Intrabony Periodontal Defect
Keywords
intrabony periodontal defect, regeneration, platelet rich fibrin, bioactive glass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model 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.
Masking
ParticipantOutcomes Assessor
Masking Description
patient and statistician will be masked about the treatment regimen
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open flap debridement and filled with A-PRF
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
open flap debridement and filled with Bioactive glass (Perioglas®)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)
Intervention Description
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 Type
Procedure
Intervention Name(s)
open flap debridement and filled with Bioactive glass (Perioglas®)
Other Intervention Name(s)
perioglas
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF
Other Intervention Name(s)
perioglas
Intervention Description
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.
Primary Outcome Measure Information:
Title
probing depth
Description
change in probing pocket depth
Time Frame
baseline, 3 months, 6 months
Title
relative attachment level
Description
change in attachment level
Time Frame
baseline, 3 months, 6 months
Title
radiographic linear bone change
Description
radiographic linear bone change through radiographic grid
Time Frame
change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Plaque index site specific
Description
Plaque index -Silness and Loe
Time Frame
baseline, 3 months, 6 months
Title
Gingival index site specific
Description
Gingival index- Loe and Silness
Time Frame
baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
surinder sachdeva, M.D.S.
Organizational Affiliation
PROFESSOR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology, M.M. College of Dental Sciences and Research.
City
Ambāla
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24945603
Citation
Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.
Results Reference
background
PubMed Identifier
17032123
Citation
Mengel R, Schreiber D, Flores-de-Jacoby L. Bioabsorbable membrane and bioactive glass in the treatment of intrabony defects in patients with generalized aggressive periodontitis: results of a 5-year clinical and radiological study. J Periodontol. 2006 Oct;77(10):1781-7. doi: 10.1902/jop.2006.060029.
Results Reference
background

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

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