Clinical trial NCT04767243: Regenerative Potential of Advanced Platelet Rich Fibrin and Bioactive Glass (Perioglas®).
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Bone Loss
Intrabony Periodontal Defect
Keywords: intrabony periodontal defect
regeneration
platelet rich fibrin
bioactive glass
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 48
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: probing depth
timeFrame: baseline, 3 months, 6 months
measure: relative attachment level
timeFrame: baseline, 3 months, 6 months
measure: radiographic linear bone change
timeFrame: change from baseline to 6 months
Secondary outcomes:
measure: Plaque index site specific
timeFrame: baseline, 3 months, 6 months
measure: Gingival index site specific
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Ambāla
country: India
facility: Department of Periodontology, M.M. College of Dental Sciences and Research.
state: Haryana
Study officials:
affiliation: PROFESSOR
name: surinder sachdeva, M.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1902/jop.2006.060029.