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

NCT ID: NCT03638154

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-15
• Study Completion Date: 2018-02-22

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.

Conditions

Periodontal Intrabony Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GroupI

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

Group Type: PLACEBO_COMPARATOR

β TCP bone substitute only

Intervention Type: PROCEDURE

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

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).

Group Type: ACTIVE_COMPARATOR

GF+GMSCs carried on β TCP

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

β TCP bone substitute only

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

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 32 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

mahetab mohamed abdel el wahab

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Gamal, professor

Role: STUDY_DIRECTOR

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

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PER 16-P1

Identifier Type: -

Identifier Source: org_study_id