跳至主要内容
临床试验/NCT06479733
NCT06479733已完成不适用

Evaluation of Buccal Pedicle Flap, Connective Tissue Graft and Acellular Dermal Matrix for Volumetric Augmentation of Peri-implant Mucosa

Ghada Elhusseiny1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2023年6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
已完成
发起方
入组人数
28
试验地点
1
主要终点
Esthetic evaluation

研究概览

简要总结

The aim of the study is to evaluate the efficacy of different soft tissue grafting techniques including buccal pedicle flap alone, free connective tissue graft and acellular dermal matrix for volumetric augmentation of peri-implant mucosa during the second stage implant surgery.

详细描述

Soft tissue grafting around dental implants has been recommended to enhance functional, biological, and esthetic outcomes. As a thick peri-implant mucosa is of importance to prevent recession, color alterations, bone remodeling and promote "creeping attachment". Two major indications include the increase of the KM width and the increase of soft tissue volume using autogenous or alternative type grafts.

Several techniques have been proposed to augment the volume of the mucosa to achieve the so-called pink esthetics: connective tissue grafts, lyophilized allogenic soft tissue grafts, porcine collagen matrix, free gingival grafts, a combination of grafting and vestibuloplasty, strip gingival autografts, tissue engineered fibroblasts, allograft, collagen matrices, and the use of the buccal pedicle flap.

Among surgical techniques, the proposed modified buccal pedicle flap was demonstrated to perform well in terms of decreased morbidity, maintenance of blood supply, stabilization of the pedicle, superior haemostasis, and speed of treatment. However, a possible drawback may be related to the original thickness of the flap since a thin mucosa phenotype may be more prompt to perforation when in contact with a cross-linked collagen matrix.

The autologous subepithelial connective tissue graft (sCTG) is generally regarded as the gold standard for soft tissue augmentation around natural teeth and dental implants. However, harvesting an autologous soft tissue graft necessarily entails additional preoperative preparation, a second surgical site, longer operative duration, and increased morbidity, regardless of the surgical technique employed and the expertise of the operator.

Another alternative for autogenous grafting is the acellular dermal matrix (ADM) allograft that is derived from human skin. ADM, originally used for treating burn wounds , is an epithelium free, freeze-dried matrix containing types I and III collagen bundles where elastic fibers are its main components . ADM acts as a bioactive scaffold that integrates in host tissue and permits the migration of fibroblasts and epithelial and endothelial cells through vascular channels of the recipient sites . Since its initial use, ADM has been widely used in dental practice, in particular for soft tissue grafting of gingival recession or to change the quality of peri-implant/teeth mucosa.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patient age : above 20 years with single or multiple edentulous spaces
  • •Healthy periodontium.
  • •Thin periodontal phenotype.
  • •Non smoker.
  • •Adequate amount of basal bone to achieve primary stability.
  • •Patient who is able to understand and sign a written consent.
  • •Patient with good oral hygiene measures and plaque index<1

排除标准

  • •• Presence of systemic , local disease or any medication that would compromise healing.
  • •Presence of infection or pathology related to the surgical area.
  • •Pregnancy and lactation.

研究组 & 干预措施

Group I (buccal pedicle flap group):

Active Comparator

Includes 7 implants that will receive implants with soft tissue augmentation using buccal pedicle flap only.

干预措施: buccal pedicle flap (Procedure)

Group II (free CTG group):

Active Comparator

Includes 7 implants that will receive implants with soft tissue augmentation using free CTG.

干预措施: connective tissue graft (Procedure)

Group III (ADM group):

Active Comparator

Includes 7 implants that will receive implants with soft tissue augmentation using acellular dermal matrix.

干预措施: acellular dermal matrix (Procedure)

Group IV (control group):

Sham Comparator

Includes 7 implants that will receive implants without soft tissue augmentation.

干预措施: control group (Procedure)

结局指标

主要结局

Esthetic evaluation

时间窗: 6 months

According to Furhauser et al., 2005, esthetic scoring index called pink esthetic score (PES) index will be used in the current study. Seven points of evaluation (mesial papilla, distal papilla, soft tissue margins, soft tissue contouring, alveolar process, soft tissue color and soft tissue texture) of score 0,1,2: this index uses a maximum score of 14, representing optimum esthetic outcome with respect to the peri-implant soft tissue conditions. The PES index fulfilled important characteristics as inclusion of the peri-implant soft tissue and the restoration-inherent parameters.

Clinical measurement of soft tissue thickness

时间窗: 6 months

At the baseline surgical visit, after local anesthetic administeration, the buccal peri-implant mucosal thickness (PMT) will be measured and recorded. An endodontic spreader will be gently inserted through the the surface of the mucosa to the bone, then the thickness measured by the spreader will be recorded using a digital caliper. The procedure will be reapeated after complete healing of the tissue

次要结局

  • modified gingival index(6 months)
  • modified plaque index(6 months)

研究者

发起方
Ghada Elhusseiny
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ghada Elhusseiny

B.D.S (Mansoura University, 2014) Assistant lecturer at Oral Medicine, Periodontology , Diagnosis and Oral Radiology department (2021)

Mansoura University

研究点 (1)

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