Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontitis

Not Applicable

Completed

• Conditions: Periodontal Intrabony Defect
• Interventions: Procedure: β TCP bone substitute only; Procedure: GF+GMSCs carried on β TCP

• Registration Number: NCT03638154
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-03-15
• Primary Completion: 2016-04-15
• Study Completion: 2018-02-22
• Study First Submitted: 2018-06-22
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-17
• Last Update Submitted: 2018-08-17
• Study First Posted: 2018-08-20
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Presence of interproximal osseous defects estimated from radiographic evaluation (Cone Beam CT) and transgingival bone sounding ≥3mm of two or three osseous walls.

  • Probing Depth ≥5mm after initial therapy.
  • Attachment loss ≥4mm.

• full mouth plaque score and bleeding on probing score ≤ 20% after phase I therapy.

  • non vital teeth only involved.
  • no furcation involvement of the teeth presenting the intraosseous defects.
  • Thick gingival biotype more than 1 mm with enough width of attached gingiva.

• Accepts Healthy Volunteers

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Exclusion Criteria

• Patients with systemic disease or compromised immune illness using Cornell medical index
• Smoker's patients.
• Pregnant and lactating females.
• Uncooperative patients (low compliance, bad oral hygiene).
• Decision impaired individuals (prisoners, handicapped and mentally retarded patients).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GroupI	β TCP bone substitute only	safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany)
GroupII	GF+GMSCs carried on β TCP	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).

Primary Outcome Measures

Name	Time	Method
bone gain in periodontal defects(by mm)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
the regenerative power of the defect was evaluated by growth factor concentration in GCF.	day 1,3,7,14 after surgery	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.