RCT
Intrabony Defects Management Using Growth Factor Enhanced Matrix Versus Platelet Rich Fibrin Utilizing Minimally Invasive Surgical Technique. A Randomized Clinical and Radiographic Trial.
Sponsor study identifier
interventional
21
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
October 1, 2019
Actual (reported)Study Completion
October 1, 2019
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)October 1, 2019
Actual (reported)October 1, 2019
Actual (reported)February 25, 2021
Actual (reported)March 8, 2021
Actual (reported)the change in probing pocket depth
the change in probing pocket depth was measured at baseline, 3,6 and 9 months evaluation period using periodontal probe
9 months
the change bleeding on probing score
the change in bleeding on probing measured at baseline,3,6 and 9 months evaluation period
9 months
the change Clinical attachment level
the change in Clinical attachment level measured at baseline, 3,6 and 9 months using the periodontal probe
9 months
Cone beam radiograph
Cone beam radiograph for measuring the change in area of the defect, depth of the depth and bone density at baseline, 3, 6 and 9 month post operative treatment using OnDemand software of cone beam
9 months
7 sites treated with Minimally invasive flap only
7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of platelet rich fibrin graft
contained defect treated with Minimally invasive flap
contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft
Malak Mohamed Shoukheba
Tanta, 020, Egypt
malak m shoukheba, phd
tanta university faculty of dentistry
21 participants (actual enrollment reported by the registry).
First Submitted
February 25, 2021
First Posted
March 8, 2021
Study Start
January 1, 2018
Actual (reported)Endoscope-assisted Flapless Approach Versus Papillary Preservation Technique in Periodontal Regeneration.
7 sites treated with Minimally invasive flap plus EDTA root conditioning and application of 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
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Primary Completion
October 1, 2019
Actual (reported)Study Completion
October 1, 2019
Actual (reported)Last Updated
June 18, 2021
Record last verified: 2021-06
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Source: ClinicalTrials.gov.
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