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

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

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

Study Overview

• Status: Completed
• Conditions: Periodontal Intrabony Defect
• Intervention / Treatment: Procedure: β TCP bone substitute only; Procedure: GF+GMSCs carried on β TCP

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 32 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: GroupI; safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany)	Procedure: β TCP bone substitute only; surgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen
Active Comparator: GroupII; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	day 1,3,7,14 after surgery

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Ahmed Gamal, professor, Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2016
• Primary Completion (Actual): April 15, 2016
• Study Completion (Actual): February 22, 2018

Study Registration Dates

• First Submitted: June 22, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PER 16-P1