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

Tracking Information

• First Submitted Date: June 22, 2018
• First Posted Date: August 20, 2018
• Last Update Posted Date: August 20, 2018
• Actual Study Start Date: March 15, 2016
• Actual Primary Completion Date: April 15, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2018)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 17, 2018)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontitis
• Official Title: Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)
• 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
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Periodontal Intrabony Defect

Intervention

• 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

• Procedure: β TCP bone substitute only
  surgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen

Study Arms

• Placebo Comparator: GroupI
  safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany)
  Intervention: Procedure: β TCP bone substitute only
• 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).

  Intervention: Procedure: GF+GMSCs carried on β TCP

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 17, 2018): 20
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 22, 2018
• Actual Primary Completion Date: April 15, 2016 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 32 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03638154
• Other Study ID Numbers: PER 16-P1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: mahetab mohamed abdel el wahab, Ain Shams University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ain Shams University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Ain Shams University
• Verification Date: August 2018