Chronic Periodontitis
Conditions
Brief summary
The present study is designed as a single-centre, randomized, controlled clinical trial to evaluate and compare the clinical efficacy of autologous PRF, 1% alendronate (ALN) and 1.2% atorvastatin (ATV) gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis.
Detailed description
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate which releases various growth factors that promote tissue regeneration. Alendronate and Atorvastatin are known to inhibit osteoclastic bone resorption and were proposed to have osteostimulative properties by causing osteoblast differentiation in vivo and in vitro as shown by an increase in matrix formation. The aim of the present study is to evaluate and compare the efficacy of autologous PRF, 1% alendronate and 1.2% atorvastatin gel placement with open flap debriedement in treatment of intrabony defects in patients with chronic periodontitis. Methods: 120 CP subjects with IBD ≥3 mm deep and probing depth (PD) ≥5 mm, following scaling and root planing (SRP), were categorized into four treatment groups: 1) OFD 2) OFD with PRF 3) OFD with 1% ALN gel and 4) OFD with 1.2% ATV gel. Clinical parameters including site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD) and relative attachment level (RAL) as well as percentage radiographic intrabony defect depth reduction (DDR) were recorded at baseline before surgery and 9 months post-operatively.
Interventions
PROCEDUREOpen flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)
BIOLOGICALOFD with PRF
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
DRUGOFD with ALN
Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
DRUGOFD with ATV
Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Systemically healthy patients with PDs ≥5mm or CALs ≥4 to 6mm and vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
Exclusion criteria
* Patients with a known systemic disease * Known or suspected allergy to the ALN/ bisphosphonates or ATV/statin group * On systemic ALN/ bisphosphonates or ATV/statin group * With aggressive periodontitis * Who used tobacco in any form * Alcoholics * Immunocompromised patients * And pregnant or lactating females were excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| defect depth reduction (DDR) | Change from baseline to 9 months |
Secondary
| Measure | Time frame |
|---|---|
| change in clinical attachment level (CAL) | Change from baseline to 9 months |
| change in probing pocket depths (PPD) | Change from baseline to 9 months |
| change in plaque index (PI) | Change from baseline to 9 months |
Outcome results
None listed