跳至主要内容
临床试验/NCT06030947
NCT06030947招募中不适用

Tunnel Surgery Combined With a Micro Connective Tissue Graft for the Treatment of Multiple Adjacent Gingival Recession Defects: a Multi-center Randomized Controlled Clinical Trial.

Göteborg University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Mean mid-facial recession coverage (mRC)

研究概览

简要总结

The objective of this project is to evaluate 1-year outcomes of treatment of MAGRD using a modified coronally advanced tunnel technique (MCAT) with either conventional CTG (control group) or micro-CTG (test group).

详细描述

Gingival recession defects (GRD) present as a partial exposure of the root surface resulting from gingival margin displacement apical to the cemento-enamel junction (CEJ). A variety of surgical methods have been reported to reestablish root coverage, including tunneling techniques and coronally and laterally advanced flaps. As the presence of thin gingival tissues is one of the predisposing factors for GRD, the adjuvant use of subepithelial connective tissue grafts (CTGs) during the surgical correction is often considered. CTGs are thought to contribute to phenotype modification and stability of treatment outcomes and studies have indicated favorable esthetic results and high degrees of root coverage (documented range: 69% to 97%). The procedure does, however, require a suitable donor site. When multiple adjacent teeth exhibit GRDs, the preferred surgical approach should offer the greatest possible root coverage, while limiting drawbacks (i.e., patient morbidity, esthetic problems). Thus, one of the challenges related to coverage of multiple GRDs is the scarcity of donor tissue. In cases when large CTGs are required, additional surgical procedures may even be necessary. As an alternative, a modification of the harvested CTG into multiple "micro-CTGs" is proposed for the treatment of multiple adjacent GRDs (MAGRD). In the present study, the effectiveness and predictability of micro-CTGs will be evaluated in direct comparison to conventional CTGs.

The investigators hypothesise that no statistically significant differences will be observed in terms of % root coverage (primary outcome) and patient satisfaction at 12 months (non-inferiority).

The investigators hypothesise that subjects in the test group (micro-CTG) will report significantly lower morbidity at 1 and 2 weeks post-surgery when compared to controls (superiority).

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
Triple (Participant, Investigator, Outcomes Assessor)

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,
  • systemically healthy,
  • presenting with a minimum of 4 and a maximum of 6 adjacent RT1/RT2 recessions, located in the maxilla or mandible with an apico-coronal extension (i.e. recession depth) of ≥2 mm,
  • Full-Mouth Plaque Score (FMPS) <20%,
  • Full-Mouth Bleeding Score (FMBS) <20%.

排除标准

  • pregnancy or lactation,
  • tobacco smoking,
  • uncontrolled medical condition,
  • medication that can affect gingival conditions.
  • thick phenotype,
  • severe tooth malpositioning,
  • uncorrected trauma from toothbrushing,
  • a previous history of root coverage procedures
  • the presence of furcation defects.

研究组 & 干预措施

Connective Tissue Graft

Active Comparator

A mucogingival surgery where a conventional connective tissue graft harvested from the palate is placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.

干预措施: Coronally Advanced Flap combined with a Connective Tissue Graft (Procedure)

Micro Connective Tissue Graft

Experimental

A mucogingival surgery where multiple micro connective tissue graft harvested from the palate are placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.

干预措施: Coronally Advanced Flap combined with micro Connective Tissue Graft (Procedure)

Micro Connective Tissue Graft

Experimental

A mucogingival surgery where multiple micro connective tissue graft harvested from the palate are placed on a recipient site prepared for modified coronally advanced tunnel and sutured to cover multiple adjacent gingival recession defects.

干预措施: Division of the Connective Tissue Graft into multiple micro Connective Tissue Grafts (Device)

结局指标

主要结局

Mean mid-facial recession coverage (mRC)

时间窗: up to 1 year

Percentage of the exposed tooth root covered after surgical intervention

次要结局

  • Complete Root Coverage (CRC)(up to 1 year)
  • Changes of Keratinized Tissue Width (KTW)(up to 1 year)
  • Changes of Gingival Thickness (GT)(up to 1 year)
  • Patient Morbidity(up to 2 weeks)
  • Patient Satisfaction(up to 1 year)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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