NCT04786327

Minimally Invasive Flap With Platelet Rich Fibrin or Growth Factor Enhanced Matrix in Treatment of Intrabony Defect

Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density

Detailed description

: Twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. Group І treated by MIST alone, group ІІ treated by MIST + ethylenediamine-tetraaceticacid (EDTA) + PRF and group III treated by MIST + EDTA + GEM 21S. The clinical parameters including probing pocket depth (PPD), clinical attachment level (CAL) and bleeding on probing (BOP), were recorded at baseline, 3, 6 and 9 months post-surgery. Cone beam computed tomography (CBCT) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.

Conditions

• Periodontal Regeneration

Interventions

Type	Name	Description
PROCEDURE	Minimal invasive flap technique	contained defect treated with Minimally invasive flap
PROCEDURE	Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin	contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft
COMBINATION_PRODUCT	minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S	contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2021-03-08
• Last updated: 2021-06-18

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study