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

NCT03638154 | Completed

• 1 other identifier: PER 16-P1
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Periodontal Intrabony Defect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  day 1,3,7,14 after surgery

Study Arms (2)

GroupI

PLACEBO COMPARATOR

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

Procedure: β TCP bone substitute only

GroupII

ACTIVE COMPARATOR

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

Interventions

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

GroupII

β TCP bone substitute only PROCEDURE

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

GroupI

Eligibility Criteria

• Age: 32 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Officials

• Ahmed Gamal, professor

  Professor of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: August 20, 2018
• Study Start: March 15, 2016
• Primary Completion: April 15, 2016
• Study Completion: February 22, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08