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Completed

NCT Number: NCT04767243

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

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.

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Key information

Conditions

Chronic Periodontitis Bone Diseases Bone Diseases, Metabolic Bone Loss Chronic Disease Disease Attributes Intrabony Periodontal Defect Metabolic Diseases Mouth Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Ambāla, Haryana, 133207, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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®)

Procedure

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

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

Drug

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

Primary outcomes

  1. probing depth

    Time frame: baseline, 3 months, 6 months

    change in probing pocket depth

  2. relative attachment level

    Time frame: baseline, 3 months, 6 months

    change in attachment level

  3. radiographic linear bone change

    Time frame: change from baseline to 6 months

    radiographic linear bone change through radiographic grid

Secondary outcomes

  1. Plaque index site specific

    Time frame: baseline, 3 months, 6 months

    Plaque index -Silness and Loe

  2. Gingival index site specific

    Time frame: baseline, 3 months, 6 months

    Gingival index- Loe and Silness

Sponsors and collaborators

Lead sponsor

Maharishi Markendeswar University (Deemed to be University)

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2021
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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