Chronic Periodontitis
Conditions
Brief summary
The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF) and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients.
Detailed description
Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate, act as reservoirs of growth factors and cytokines which are the key factors for regeneration of the bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and promoting osteoblastogenesis. The present study was designed to evaluate the combined efficacy of PRF and 1% ALN with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis patients. Methods: Ninety patients with single defects were categorized into three groups: OFD alone, OFD with PRF,OFD with PRF+1% ALN. Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL) and gingival marginal level (GML) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic intra-bony defect depth reduction (IBD) was evaluated at baseline and 9 months.
Interventions
PROCEDUREOpen flap debridement (OFD)
Oral prophylaxis followed by Open flap debridement (OFD)
PROCEDUREOFD with Platelet rich fibrin (PRF)
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
PROCEDUREOFD with Platelet rich fibrin (PRF)+1% Alendronate
Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate 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
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Presence of 3-wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an Intra-oral Periapical Radiograph \[IOPA\]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing\[SRP\]) in asymptomatic teeth.
Exclusion criteria
* Aggressive Periodontitis patients; * Systemic conditions known to affect the periodontal status; * medications known to affect the outcomes of periodontal therapy; * Hematological disorders and insufficient platelet count (\<200,000/mm3); * Pregnancy/lactation; * Smoking and tobacco use in any form * Immunocompromised individuals. * Those having unacceptable oral hygiene (plaque index27 \[PI\] \>1.5) after reevaluation of Phase I therapy . * Teeth with furcation involvement, non-vital teeth, carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| defect depth reduction (%) | Change from baseline to 9 months | assessed in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| probing depth (mm) | Change from baseline to 9 months | measured in mm |
| clinical attachment level (mm) | Change from baseline to 9 months | measured in mm |
| gingival marginal level (mm) | Change from baseline to 9 months | measured in mm |
| modified sulcus bleeding index | Change from baseline to 9 months | scale from 0-3 |
| plaque index | Change from baseline to 9 months | scale from 0-3 |
Countries
India
Outcome results
None listed