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

• ClinicalTrials.gov Identifier: NCT03638154
• Recruitment Status: Completed
• First Posted: August 20, 2018
• Last Update Posted: August 20, 2018
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): mahetab mohamed abdel el wahab, Ain Shams University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Periodontal Intrabony Defect	Procedure: GF+GMSCs carried on β TCP; Procedure: β TCP bone substitute only	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)
• Actual Study Start Date: March 15, 2016
• Actual Primary Completion Date: April 15, 2016
• Actual Study Completion Date: February 22, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

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

Criteria

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).

Contacts and Locations

Sponsors and Collaborators

Ain Shams University

Investigators

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

  Study Documents (Full-Text)

Documents provided by mahetab mohamed abdel el wahab, Ain Shams University:

Study Protocol  [PDF] January 22, 2016

More Information

• Responsible Party: mahetab mohamed abdel el wahab, Principal Investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03638154
• Other Study ID Numbers: PER 16-P1
• First Posted: August 20, 2018
• Last Update Posted: August 20, 2018
• Last Verified: August 2018