An interventional study of GF+GMSCs carried on β TCP and β TCP bone substitute only in Periodontal Intrabony Defect, sponsored by Ain Shams University. Completed. Open to participants aged 32 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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
In the present study, twenty posterior two or three osseous intrabony periodontal defects were involved . They were grouped in to two groups. Group I included ten intrabony posterior defect received beta tri calcium phosphate (β TCP) bone substitute. Group II included ten posterior intrabony periodontal defect and they 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. CBCT was used preoperatively and after 6 months for hard tissue evaluation. PDGF and BMP were measured in GCF at days 1,3,7,14.
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Presence of interproximal osseous defects estimated from radiographic evaluation (Cone Beam CT) and transgingival bone sounding ≥3mm of two or three osseous walls.
full mouth plaque score and bleeding on probing score ≤ 20% after phase I therapy.
Exclusion Criteria:
safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany)
Procedure: β TCP bone substitute only
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).
Procedure: GF+GMSCs carried on β TCP
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
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.
Time frame: 6 months
the regenerative power of the defect was evaluated by growth factor concentration in GCF.
4 GCF samples were collected from each patient at day 1,3,7,14 after periodontal surgery then a Biochemical analysis of BMP-2 and PDGF-bb (by mg /dl) concentrations in GCF by using ELIZA kite which reflect the healing power at the initial periods of healing in different groups.
Time frame: day 1,3,7,14 after surgery
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Ain Shams University