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

Maharishi Markendeswar University (Deemed to be University)

Status and phase: Completed; Phase 4

Conditions: Chronic Periodontitis; Intrabony Periodontal Defect; Bone Loss

Treatments: Drug: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF; Procedure: open flap debridement and filled with Bioactive glass (Perioglas®); Procedure: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)

Study type: Interventional

Funder types: Other

Identifiers

NCT04767243

1597

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 3 patient groups

open flap debridement and filled with A-PRF

Sham Comparator group

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.

Treatment:

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

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

Active Comparator group

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.

Treatment:

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

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

Active Comparator group

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.

Treatment:

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