A Phase 2/3 interventional study of Open flap debridement (OFD) and OFD with Platelet rich fibrin (PRF) in Furcation Defects, sponsored by Government Dental College and Research Institute, Bangalore. Completed at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-05.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment
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.
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.
42 studies on the registry are indexed under Furcation Defects; 13 are open to participants now.
This study's enrollment of 75 is above the median of 27 across 38 interventional studies indexed under Furcation Defects.
Browse Furcation Defects studies →Government Dental College and Research Institute, Bangalore is the lead sponsor of 38 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Aggressive periodontitis patients
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Scaling and Root Planing (SRP) with Open flap debridement (OFD) alone for treating furcation defect
Procedure: Open flap debridement (OFD)
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF) for treating furcation defect
Procedure: OFD with Platelet rich fibrin (PRF)
SRP with Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Metformin for treating furcation defect
Procedure: OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form
Open flap debridement (OFD) alone
Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement
Radiographic bone fill assessed in percentage
assessed in percentage
Time frame: baseline to 9 months
probing depth measured in mm
measured in mm
Time frame: baseline to 9 months
Relative vertical attachment level measured in mm
measured in mm
Time frame: baseline to 9 months
Relative horizontal attachment level measured in mm
measured in mm
Time frame: baseline to 9 months
modified sulcus bleeding index
0-3 scale
Time frame: baseline to 9 months
plaque index
0-3 scale
Time frame: baseline to 9 months
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Government Dental College and Research Institute, Bangalore