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Completed

NCT Number: NCT03638154

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

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

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Key information

Age range

32 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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).

Treatment and study plan

GF+GMSCs carried on β TCP

Procedure

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

β TCP bone substitute only

Procedure

surgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen

Primary outcomes

  1. bone gain in periodontal defects(by mm)

    Time frame: 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 outcomes

  1. the regenerative power of the defect was evaluated by growth factor concentration in GCF.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)

Important dates

Study start
2016
Primary completion
2016
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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