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

Phase 4

Completed

• Conditions: Chronic Periodontitis; Intrabony Periodontal Defect; Bone Loss
• Interventions: Procedure: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin); Procedure: open flap debridement and filled with Bioactive glass (Perioglas®); Drug: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF

• Registration Number: NCT04767243
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

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.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-20
• Study First Posted: 2021-02-23
• Primary Completion: 2022-02-18
• Study Completion: 2022-03-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-05
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
probing depth	baseline, 3 months, 6 months	change in probing pocket depth
relative attachment level	baseline, 3 months, 6 months	change in attachment level
radiographic linear bone change	change from baseline to 6 months	radiographic linear bone change through radiographic grid

Secondary Outcome Measures

Name	Time	Method
Plaque index site specific	baseline, 3 months, 6 months	Plaque index -Silness and Loe
Gingival index site specific	baseline, 3 months, 6 months	Gingival index- Loe and Silness

Trial Locations

Locations (1)

Department of Periodontology, M.M. College of Dental Sciences and Research.; 🇮🇳 Ambāla, Haryana, India