Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)
Sponsor study identifier
interventional
20
0 countries
N/A
Study Start
March 15, 2016
Actual (reported)Primary Completion
April 15, 2016
Actual (reported)Study Completion
February 22, 2018
Actual (reported)clinical trial was conducted to evaluate regenerative potentials of cultured gingival fibroblasts and GMSCs carried in beta tri calcium phosphate scaffold into intrabony periodontal defects in human by clinical and radiographic parameters
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 22, 2018
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2016
Actual (reported)April 15, 2016
Actual (reported)February 22, 2018
Actual (reported)June 22, 2018
Actual (reported)August 20, 2018
Actual (reported)bone gain in periodontal defects(by mm)
20 patients were involved as assessed by cone beam ct at baseline (pre) and 6 months later(post). the fusion of pre and post operative cone beam ct scan of the intrabony periodontal defect to measure bone gain by mm. so that, the regenerative potentials of cultured gingival into ten intrabony defect fibroblasts and GMSCs carried by tri calcium phosphate , the bone gain was measured by radiographic fusion of pre and post image of intrabony periodontal defects in human.
6 months
the regenerative power of the defect was evaluated by growth factor concentration in GCF.
day 1,3,7,14 after surgery
safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany)
safety with surgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane and received a mixture of gingival fibroblast(GF) and gingival mesenchymal stem cells(GMSCs) carried on a vehicle of β TCP covered by a resorbable collagen membrane. (Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Jersey, USA).
surgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Gersey, USA). Ibuprofen
surgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen
Ahmed Gamal, professor
Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University
20 participants (actual enrollment reported by the registry).
First Submitted
June 22, 2018
First Posted
August 20, 2018
Study Start
March 15, 2016
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
April 15, 2016
Actual (reported)Study Completion
February 22, 2018
Actual (reported)Last Updated
August 20, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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