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

Ain Shams University

Status: Completed

Conditions: Periodontal Intrabony Defect

Treatments: Procedure: β TCP bone substitute only; Procedure: GF+GMSCs carried on β TCP

Study type: Interventional

Funder types: Other

Identifiers

NCT03638154

PER 16-P1

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 32 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

GroupI

Placebo Comparator group

Description:

safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany)

Treatment:

Procedure: β TCP bone substitute only

GroupII

Active Comparator group

Description:

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).

Treatment:

Procedure: GF+GMSCs carried on β TCP