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 2015-11-20.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment
The present study was designed to evaluate the combined efficacy of PRF and 1% ALN in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.
Background: Various regenerative materials have been introduced and tested in the treatment of furcation defects. Platelet-rich fibrin (PRF) is a reservoir of growth factors and cytokines which are the key factors for regeneration of 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 in the treatment of mandibular degree II furcation defects when compared with PRF and open flap debridement (OFD) alone.
Methods: Seventy two mandibular furcation defects were treated with either OFD alone (Group 1), OFD with PRF (Group 2), and OFD with PRF+1% ALN (Group 3). Clinical parameters; site specific plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), intrabony defect depth (IBD) were recorded at baseline before surgery and 9 months post-operatively. Percentage radiographic defect fill was evaluated 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 72 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:
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% Alendronate for treating furcation defect
Procedure: OFD with Platelet rich fibrin (PRF)+1% Alendronate (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% Alendronate gel placement
Radiographic bone fill
assessed in percentage
Time frame: baseline to 9 months
probing depth
measured in mm
Time frame: baseline to 9 months
Relative vertical attachment level
measured in mm
Time frame: baseline to 9 months
Relative horizontal attachment level
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
The record gives a start of Jan 2015, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Government Dental College and Research Institute, Bangalore