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临床试验/NCT05045586
NCT05045586Unknown不适用

Modified Coronally Advanced Tunnel With Cross-linked Hyaluronic Acid in Addition to Connective Tissue Graft Compared With Subepithelial Connective Tissue Graft Alone for Treatment of Multiple Gingival Recession: Randomized Clinical Trial

Medical University of Warsaw2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
2
主要终点
Periodontal parameters measured before surgery.

研究概览

简要总结

Microsurgical tunneling flap procedures using connective tissue grafts (CTG) are predictable for treating teeth with gingival recessions. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results. The aim of this study is to evaluate clinically the use of tunnel technique with CTG and cross-linked hyaluronic acid in addition to CTG alone for the treatment of multiple gingival recessions.

详细描述

The treatment of multiple adjacent recession appears to be challenging for the clinician due to large surgical field, variation in teeth position in the dental arch (prominent roots), variation in recession size, thin phenotype and insufficient keratinized tissue in many teeth. Surgical treatment of all multiple recession in one dental arch during one session appears to be optimum. Surgical treatment time is longer, however patient doesn't need to undergo multiple surgeries, pharmacological therapies and postsurgical instructions. Esthetic concern seems to be one of the most common complaints from patients. Among utilized surgical techniques tunneling flap procedures using connective tissue grafts (CTG) with or without biologics such as an enamel matrix derivative (EMD) or hyaluronic acid (HA) provided the most successful outcomes for the treatment. Cross-linked hyaluronic acid can be used in conjunction with subepithelial palatal connective tissue grafts to improve postsurgical results and improving healing process. The aim of this study is to evaluate clinically the use of tunnel technique with CTG and cross-linked hyaluronic acid in addition to CTG alone for the treatment of multiple gingival recessions.

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, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Bilateral multiple gingival recessions in homologous teeth

排除标准

  • Full-mouth plaque index ≥ 20% (Ainamo & Bay 1975)
  • Full-mouth sulcus bleeding index ≥ 15% (Mühlemann & Son 1971)
  • Systemic diseases with compromised healing potential of infectious diseases
  • Drugs affecting periodontal health / healing
  • Pregnant and lactating females
  • Previous periodontal surgery in the area

结局指标

主要结局

Periodontal parameters measured before surgery.

时间窗: 1-7 days before surgery

1. Probing pocket depth (PPD) MEASURED IN MILIMETERS: distance from the gingival margin to the bottom of the gingival sulcus 2. Clinical attachment level (CAL) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the bottom of the gingival sulcus 3. Recession height (RH) MEASURED IN MILIMETERS: distance from the cementoenamel junction to the gingival margin 4. Width of keratinized tissue (WKT) MEASURED IN MILIMETERS: distance between the most apical point of the gingival margin and the mucogingival junction 5. Gingival thickness (GT) MEASURED IN MILIMETERS: thickness of the gingiva measured 2-3 mm apical to the gingival margin

次要结局

  • Periodontal parameters measured after surgery.(12 months after surgery)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (2)

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