跳至主要内容
临床试验/NCT04319770
NCT04319770已完成不适用

Effectiveness of Hyaluronic Acid Versus Enamel Matrix Derivatives in the Regeneration of Infrabony Defects. A Randomized Controlled Clinical Trial

University of Roma La Sapienza0 个研究点目标入组 32 人开始时间: 2016年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
主要终点
clinical attachment level (CAL)

研究概览

简要总结

The purpose of this randomized controlled clinical trial (RCT) is to determine the efficacy hyaluronic acid (HA) versus enamel matrix derivatives (EMD) in the treatment of infrabony periodontal defects.

详细描述

Intrabony defects associated with periodontal pockets represent a risk factor for periodontitis progression and additional loss of attachment if left untreated.

Over the years, several strategies have been implemented for their surgically reconstruction with the aim of pocket reduction and clinical attachment level gain.

Grafting of intrabony periodontal defects has been used extensively over the years incorporating various materials, including autogenic bone, demineralized allogenic bone, xenogenic and alloplastic materials. Controlled clinical studies have shown a significantly higher gain of clinical attachment and radiographic bone gain in intra-bony periodontal defects treated with open flap debridement combined with EMD when compared with open flap debridement alone.

Hyaluronic acid (HAc) is a naturally occurring linear polysaccharide of the extracellular matrix of connective tissue, synovial fluid, and other tissues. It possesses various physiological and structural functions, which include cellular and extracellular interactions, interactions with growth factors and regulation of the osmotic pressure, and tissue lubrication. All these functions help in maintaining the structural and homeostatic integrity of the tissue.

In the field of dentistry, in vitro and animal studies have demonstrated that hyaluronic acid prevents oxygen free-radical damage to granulation tissue, stimulates the clot formation , induces angiogenesis and does not interfere in the calcification nodule during bone formation.

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

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient related:
  • adults aged 18-65 years with periodontal disease
  • sites with infrabony defects and persisting pockets [probing pocket depth (PPD) ≥ 5 mm and bleeding on probing (BOP)] at re-evaluation 6 weeks after non-surgical periodontal therapy
  • full-mouth plaque score (FMPS)1 and full-mouth bleeding score (FMBS)2 < 20% before surgery
  • at least one radiographically detectable infrabony lesion,3
  • good physical health.
  • Site-specific:
  • Interproximal angular defects on single-rooted teeth
  • radiographic infrabony component ≥ 3 mm
  • PPD ≥ 6 mm and CAL ≥ 7 mm.

排除标准

  • relevant medical conditions contraindicating surgical interventions
  • pregnancy or lactation
  • tobacco smoking
  • untreated periodontal conditions
  • any condition associated with poor compliance or failure to maintain good oral hygiene
  • acute infectious lesions in areas intended for surgery
  • teeth with grade 2 or higher mobility
  • restorations or carious lesions on root surfaces that are associated with the intrabony defect.

结局指标

主要结局

clinical attachment level (CAL)

时间窗: baseline, 12, 28 and 24 months

Changes in CAL between initial and final. Measured in mm

次要结局

  • probing pocket depth (PPD)(baseline, 12, 28 and 24 months)
  • gingival recession (GR)(baseline, 12, 28 and 24 months)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Pilloni MD DDS MS

Chairman Section of Periodontics Director of Master Program in Periodontics

University of Roma La Sapienza

相似试验