Furcation Defects
Conditions
Brief summary
The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone.
Detailed description
Background: For improving efficacy and outcomes of regenerative therapy for furcation defects, various materials has been investigated in addition to access therapy. Platelet-rich fibrin (PRF) having concentrated growth factors and cytokines and Metformin (MF), an efficacious member of biguanide group are known to enhance periodontal regeneration. The aim of the present trial is to evaluate the efficacy of PRF with 1% MF in treatment of mandibular class II furcation defects and its comparison to PRF and access therapy alone. Methods: This randomized trial was conducted on 75 patients with mandibular class II furcation defects. Defects were surgically treated with either access therapy alone (Group 1), access therapy+PRF (Group 2), and access therapy+ PRF+1% MF (Group 3). Clinical parameters like probing depth (PD), relative clinical attachment level {vertical (RVCAL) and horizontal (RHCAL)}, modified sulcus bleeding index (mSBI) and site specific plaque index (PI) were evaluated at baseline and 9 months post-operatively. Radiological assessment of bone defect fill was done at baseline and 9 months.
Interventions
PROCEDUREOpen flap debridement (OFD)
Open flap debridement (OFD) alone
PROCEDUREOFD with Platelet rich fibrin (PRF)
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
PROCEDUREOFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Buccal degree II furcation defects in endodontically vital, asymptomatic mandibular first and second molars with a radiolucency in the furcation area on an intraoral periapical radiograph with probing depth (PD) ≥ 5mm and horizontal ≥ PD 3mm after phase I therapy i.e, scaling and root planing (SRP); * No history of antibiotic or periodontal therapy in the preceding 6 months.
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 (\<100,000/mm3); * Pregnancy/lactation; * Smoking and tobacco use in any form * Immunocompromised individuals; * Those having unacceptable oral hygiene (plaque index \[PI\] \>1.5). * Teeth with furcation involvement, non-vital teeth, and carious teeth indicated for restorations and mobility of at least grade II were also excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic bone fill assessed in percentage | baseline to 9 months | assessed in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| probing depth measured in mm | baseline to 9 months | measured in mm |
| Relative vertical attachment level measured in mm | baseline to 9 months | measured in mm |
| Relative horizontal attachment level measured in mm | baseline to 9 months | measured in mm |
| modified sulcus bleeding index | baseline to 9 months | 0-3 scale |
| plaque index | baseline to 9 months | 0-3 scale |
Countries
India
Outcome results
None listed