跳至主要内容
临床试验/NCT06037694
NCT06037694招募中不适用

Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft: a Multi-center Randomized Controlled Trial.

Göteborg University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1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
1
主要终点
Changes of Keratinized Mucosa width (KMW)

研究概览

简要总结

The overall objective of this project is to evaluate, over a period of 1 year, the outcomes of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of keratinized mucosa (KM) at implant sites.

详细描述

The importance of the width of keratinized mucosa (KM) at implant sites remains a subject of ongoing debate. Reduced dimensions of KM (width <2 mm) are associated with mucosal recession, biofilm accumulation, soft-tissue inflammation, marginal bone loss, peri-implantitis and patient discomfort. Surgical options to increase the width of KM include an apically positioned flap, either alone or in combination with an autogenous graft or a xenogeneic collagen matrix. The free gingival graft (FGG) is a well-established technique with a history of successful clinical use. The harvesting procedure for autogenous graft from the palatal mucosa, however, is usually associated with significant patient morbidity, especially when there is a need to graft extensive mucosal areas. To overcome this problem, various graft modifications have been proposed to limit the need for large-area autografts. Examples include the accordion technique, the strip gingival autograft technique, and a vertical modification of the strip gingival graft. The expanded mesh graft, another graft modification, has been used in the field of plastic surgery, especially in the treatment of large burn wounds. Recently, De Greef, Carcuac, De Mars et al. proposed this technique to be used in periodontal plastic surgery, more specifically, in the widening of KM at implant sites by means of a meshed free gingival graft (mesh-FGG). In this case series, initially inadequate width of KM in edentulous areas could be successfully increased prior to implant installation, without the need for any extensive autograft harvesting. Data from trials comparing mesh-FGG to conventional FGG and assessing the long-term efficacy of this novel technique, however, are missing.

The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical results (non-inferiority: increase in KM width) but improved patient-reported outcomes (superiority: post-surgical morbidity) compared to the FGG.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥18 years of age,
  • •systemically healthy,
  • •presence of ≥2 adjacent implants in both sides of the mandibles showing <2 mm of KM on the buccal aspects,
  • •subjects have to present with discomfort from brushing and/or difficulties in maintaining proper home care due to inadequate dimension of KM
  • •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.

研究组 & 干预措施

Free Gingival Graft

Active Comparator

A mucogingival surgery where a conventional free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.

干预措施: Conventional Free Gingival Graft (Procedure)

Meshed Free Gingival Graft

Experimental

A mucogingival surgery where a meshed free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.

干预措施: 'Mesh Free Gingival Graft (Procedure)

结局指标

主要结局

Changes of Keratinized Mucosa width (KMW)

时间窗: up to 1 year

Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa

次要结局

  • Changes of Keratinized Mucosa Thickness (KMT)(up to 1 year)
  • Patient Satisfaction(up to 1 year)
  • Patient Morbidity(up to 2 weeks)

研究者

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

研究点 (1)

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