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临床试验/NCT06808243
NCT06808243已完成不适用

Modified Vascularized Interpostional Periosteal Connective Tissue Graft Versus Xenogeneic Collagen Matrix for Soft Tissue Augmentation Around Implant in Esthetic Zone (Comparative Study)

Minia University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
keratinized tissue thickness

研究概览

简要总结

This clinical trial aims to evaluate the effectiveness of the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (mVIP-CTG) compared to Xenogeneic Collagen Matrix (XCM) around immediate implant in esthetic zone . This study will assess outcomes such as keratinized tissue thickness, keratinized tissue width, pink esthetic score and radiographic buccal cortex thickness over a defined follow-up period. By comparing mVIP-CTG to XCM, the study seeks to determine which method provides superior clinical and aesthetic results for best soft tissue augmentation

详细描述

This study investigates two surgical techniques for managing peri-implant soft tissue deficiencies: the Modified Vascularized Interpositional Periosteal Connective Tissue Graft (VIP-CTG) and the Xenogeneic Collagen Matrix (XCM). Peri-implant soft tissue deficiencies, characterized by inadequate tissue volume or recession around dental implants, can lead to complications such as implant exposure, sensitivity, and aesthetic concerns. Conventional treatment methods aim to enhance soft tissue volume and improve the aesthetic and functional outcomes of implants.

The mVIP-CTG approach utilizes autogenous pedicle grafts to improve tissue thickness and width, potentially enhancing soft tissue integration and thickness around immediate implants. In contrast, XCM is a xenogenic membrane offering a minimally invasive alternative substitute for soft tissue regeneration.

The study design includes randomized assignment of participants to either the mVIP-CTG group or XCM group, with standardized surgical and follow-up protocols. Primary and secondary outcomes will include peri-implant soft tissue thickness, keratinized tissue width, pink esthetic score, and radiographic buccaal cortex thickness. Statistical analysis will evaluate the comparative effectiveness of both techniques in promoting peri-implant soft tissue regeneration and aesthetic recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • systemically healthy
  • teeth indicated for extraction due to trauma or root fracture
  • periodontally healthy
  • Good oral health
  • Selected patients of both sexes are 20-40 years old.

排除标准

  • parafunctional habits
  • smoking, alcoholism
  • pregnancy
  • lactation
  • untreated periodontal diseases

结局指标

主要结局

keratinized tissue thickness

时间窗: baseline, 3 months, 6 months

measurement of Kertinized tissue thickness around implant using endodontic file

keratinized tissue width

时间窗: baseline, 3 months and 6 months

measurement of keratinized tissue width using graduated UNC-15 Probe

buccal cortex thickness

时间窗: baseline and 6 months

measurement of buccal cortex thickness using CBCT

次要结局

  • pink esthetic score(baseline and 6 months)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

heba ahmed abdelmaged

Teaching assistant

Minia University

研究点 (2)

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