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

Chronic Periodontitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767243
• Other study ID #: 1597
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: March 4, 2022

Study information

• Verified date: November 2022
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 4, 2022
• Est. primary completion date: February 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Loss
• Chronic Periodontitis
• Intrabony Periodontal Defect
• Periodontitis

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
India	Department of Periodontology, M.M. College of Dental Sciences and Research.	Ambala	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probing depth	change in probing pocket depth	baseline, 3 months, 6 months
Primary	relative attachment level	change in attachment level	baseline, 3 months, 6 months
Primary	radiographic linear bone change	radiographic linear bone change through radiographic grid	change from baseline to 6 months
Secondary	Plaque index site specific	Plaque index -Silness and Loe	baseline, 3 months, 6 months
Secondary	Gingival index site specific	Gingival index- Loe and Silness	baseline, 3 months, 6 months