NCT04767243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

February 9, 2021

Last Update Submit

November 5, 2022

Conditions

Chronic PeriodontitisBone LossIntrabony Periodontal Defect

Keywords

intrabony periodontal defectregenerationplatelet rich fibrinbioactive glass

Outcome Measures

Primary Outcomes (3)

  • probing depth

    change in probing pocket depth

    baseline, 3 months, 6 months

  • relative attachment level

    change in attachment level

    baseline, 3 months, 6 months

  • radiographic linear bone change

    radiographic linear bone change through radiographic grid

    change from baseline to 6 months

Secondary Outcomes (2)

  • Plaque index site specific

    baseline, 3 months, 6 months

  • Gingival index site specific

    baseline, 3 months, 6 months

Study Arms (3)

open flap debridement and filled with A-PRF

SHAM COMPARATOR

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)

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

ACTIVE COMPARATOR

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®)

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

ACTIVE COMPARATOR

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

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 A-PRF
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.

Also known as: perioglas
open flap debridement and filled with Bioactive glass (Perioglas®)
open flap debridement and filled Bioactive glass (Perioglas®) and A-PRFDRUG

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

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ambāla, Haryana, 133207, India

Location

Related 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.

    PMID: 24945603BACKGROUND

  • 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.

    PMID: 17032123BACKGROUND

MeSH Terms

Conditions

Chronic PeriodontitisBone Diseases, Metabolic

Interventions

Bioglass

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • surinder sachdeva, M.D.S.

    PROFESSOR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
patient and statistician will be masked about the treatment regimen
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 23, 2021

Study Start

December 1, 2020

Primary Completion

February 18, 2022

Study Completion

March 4, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)