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CompletedNCT04767243Updated Nov 8, 2022

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

A Phase 4 interventional study of open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin) and open flap debridement and filled with Bioactive glass (Perioglas®) in Chronic Periodontitis, Bone Loss and Intrabony Periodontal Defect, sponsored by Maharishi Markendeswar University (Deemed to be University). Completed at 1 site in India. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Maharishi Markendeswar University (Deemed to be University) · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Chronic Periodontitis
  • Bone Loss
  • Intrabony Periodontal Defect

Keywords

  • intrabony periodontal defect
  • regeneration
  • platelet rich fibrin
  • bioactive glass
03

In context

Chronic Periodontitis

386 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.

This study's enrollment of 48 is close to the median of 46 across 314 interventional studies indexed under Chronic Periodontitis.

Browse Chronic Periodontitis studies →

Lead sponsor

Maharishi Markendeswar University (Deemed to be University) is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Sham comparator
    open flap debridement and filled with 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 A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.

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

  • Active comparator
    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.

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

  • Active comparator
    with 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.

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

Interventions

  • Procedureopen 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.

  • Procedureopen 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.

    Also known as: perioglas

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

    Drug page: Calcium sodium phosphosilicate

    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.

    Also known as: perioglas

06

What researchers measure

Primary outcomes

  1. probing depth

    change in probing pocket depth

    Time frame: baseline, 3 months, 6 months

  2. relative attachment level

    change in attachment level

    Time frame: baseline, 3 months, 6 months

  3. radiographic linear bone change

    radiographic linear bone change through radiographic grid

    Time frame: change from baseline to 6 months

Secondary outcomes

  1. Plaque index site specific

    Plaque index -Silness and Loe

    Time frame: baseline, 3 months, 6 months

  2. Gingival index site specific

    Gingival index- Loe and Silness

    Time frame: baseline, 3 months, 6 months

07

Study locations

1 site
  • Department of Periodontology, M.M. College of Dental Sciences and Research.
    Ambāla, Haryana 133207, India
08

References and documents

Publications

  • 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. PubMed 24945603 ↗
  • 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. PubMed 17032123 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04767243
Lead sponsor
Maharishi Markendeswar University (Deemed to be University)
Responsible party
DR SURINDER SACHDEVA (PROFESSOR, Maharishi Markendeswar University (Deemed to be University)) — Principal investigator
First posted
Feb 23, 2021
Start date
Dec 1, 2020
Primary completion
Feb 18, 2022
Completion
Mar 4, 2022
Last update
Nov 8, 2022

Study contacts

surinder sachdeva, M.D.S.
principal investigator · PROFESSOR

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Calcium sodium phosphosilicate

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