Clinical Regenerative Potential of Cultured Gingival Fibroblast- Mesenchymal Stem Cells in Treatment of Periodontal Intrabony Defects (Randomized Clinical and Biochemical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- bone gain in periodontal defects(by mm)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 32 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
GroupI
safety with received beta-tricalcium phosphate (β TCP) bone substitute only. (Bioresorb, Sybron, implant solutions GmbH Bremen, Germany)
干预措施: β TCP bone substitute only (Procedure)
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).
干预措施: GF+GMSCs carried on β TCP (Procedure)
结局指标
主要结局
bone gain in periodontal defects(by mm)
时间窗: 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.
次要结局
- the regenerative power of the defect was evaluated by growth factor concentration in GCF.(day 1,3,7,14 after surgery)
研究者
mahetab mohamed abdel el wahab
Principal Investigator
Ain Shams University