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临床试验/NCT03707483
NCT03707483Unknown2 期

The Effect of Combination of Vitamin C and Platelet Rich Fibrin (PRF) Versus Platelet Rich Fibrin Alone on Clinical Attachment Gain in Patients With Stage III Periodontitis: A Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 20 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
20
主要终点
gain in clinical attachment level

研究概览

简要总结

This study is meant to assess clinically the possible predictable clinical attachment gain regarding the use of vitamin C with platelet rich fibrin versus platelet rich fibrin alone in the treatment of periodontal intrabony defects

详细描述

Treatment of intra-osseous defects through incorporation of vitamin C into platelet rich fibrin scaffold aims to enhance the biologic potential of the endogenous mesenchymal stem cells that exist within the periodontal ligaments and stimulate periodontal tissue regeneration(Yan et al., 2013). As the concept of periodontal tissue-engineering has emerged, many inductive biomolecules were investigated for periodontal regeneration(Bartold et al., 2000).

Vitamin C has shown promising results in periodontal regeneration, in a study vitamin C was suggested to enhance osteoblastic differentiation of periodontal ligament cells through modulating type I collagen-α1β2 integrin interaction leading to increased ALP activity in periodontal ligament cells(Ishikawa et al., 2004). Vitamin C treatment induces expression of cementogenic genes and considered to be a more feasible and safer treatment for clinical cell-based periodontal regeneration(Gauthier et al., 2017).

There is also a study concluding that vitamin C induces the osteogenic differentiation of PDL progenitor cells via PELP1-ERK axis; and this implies that vitamin C may have a potential in the periodontal regeneration(Yan et al., 2013).

Periodontal tissue regeneration aims to increase periodontal in intra-osseous defects thus improving clinical attachment level; reducing probing depth and upgrading the prognosis of teeth(Ramseier et al., 2012).

Resolution of intra-osseous defects through regeneration preserves and improves function and provides patient comfort(Wang et al., 2005). It also facilitates supportive periodontal therapy; performed regularly to maintain periodontal health(Ramseier et al., 2012).

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 (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patient consulting in the outpatient clinic.
  • Able to tolerate surgical periodontal procedures.
  • Patient ready to perform oral hygiene instructions.
  • Compliance with the maintenance program.
  • Provide informed consent.
  • Accept the 6 months follow-up period
  • Mature permanent tooth.
  • Tooth with two or three-walled intra-bony defect, CAL ≥ 5mm with intra-osseous defect ≥ 3mm.

排除标准

  • Medically compromised patients.
  • Pregnant or nursing women.
  • Uncooperative patients.
  • Teeth with one wall intra-bony defect.
  • Teeth with supra-bony defects.
  • Teeth with grade III mobility.

研究组 & 干预措施

Intervention

Experimental

250 μM of vitamin C will be used with the platelet rich fibrin

干预措施: combination of vitamin C and platelet rich fibrin (Combination Product)

Comparator

Active Comparator

using platelet rich fibrin alone

干预措施: combination of vitamin C and platelet rich fibrin (Combination Product)

结局指标

主要结局

gain in clinical attachment level

时间窗: 6 months

Measured from the CEJ to the bottom of the gingival sulcus

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Talaat Mohamed Mahmoud El Behwashy

Dentist

Cairo University

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