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临床试验/NCT02935426
NCT02935426Unknown不适用

Comparison of Cyanoacrylate Tissue Adhesives to Polytetrafluoroethylene (PTFE) Sutures in the Donor Site of Connective Tissue Grafts- A Randomized Clinical Trial

University of Manitoba2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
32
试验地点
2
主要终点
Patient's discomfort from the donor site

研究概览

简要总结

Cyanoacrylate tissue adhesives have been successfully used for wound closure. The purpose of this clinical trial is to compare cyanoacrylate tissue adhesives to polytetrafluoroethylene (PTFE) sutures in the donor site of connective tissue grafts. Two groups of volunteers will randomly assigned to one of the two study groups. The wound closure at the palatal donor area will be achieved with polytetrafluoroethylene (PTFE) sutures in one group and with high viscosity cyanoacrylate tissue adhesives on the other group. The surgical procedure will be performed by one of three calibrated periodontics residents. Data will be collected at baseline-day of the surgery and in one week post-operatively. The primary outcome is patient's discomfort from the donor site during the first week after the surgery. Secondary outcomes is the time required for suture placement or cyanoacrylate application, patient's pain from donor and recipient site one week post-operatively, painkillers intake, presence or absence of inflammation and modified EHI early-wound healing index.

详细描述

A prospective, randomized clinical trial will be conducted to determine whether cyanoacrylate tissue adhesives or sutures are better tolerated by patients receiving soft tissue gum grafts.

Periodontal plastic surgery procedures have become an integral part of periodontal treatment by addressing esthetic and functional demands. Several therapeutic modalities such as free gingival graft, pedicle flaps, connective tissue grafts, grafts combining the two lateral modalities and guided tissue regeneration have been used for covering the denuded roots and augmenting the width and thickness of the keratinized gingiva. Among various surgical techniques, subepithelial connective tissue (SECT) grafts remain the most commonly used and most successful root coverage procedures. The esthetic and functional success of SECT graft techniques is highly predictable and reliable and they have given them a common place in the clinical practice. Subepithelial connective tissue graft procedures require harvesting tissue from a donor area, usually the palate. This addition of another surgical site extends the complexity of the procedure and increases patient discomfort.

Single interrupted or continuous interlocking sutures are suggested at the donor site. Suturing is the most common method of wound closure. Other biomaterials such as staples, adhesive tapes, adhesive glues and fibrin sealants have been used generally to hasten the pace of healing. Adhesives interact with different materials, merge and allow them to remain whole. Cyanoacrylates are bio-adhesives that were discovered by Ardis in 1949 and first used for surgery by Coover et al in 1959. When applied to two opposing, wet, living tissue surfaces, they have the ability to cement them in place. Their general chemical formula is CH2=C(CN)-COOR , where R can be substituted for any alkyl group, ranging from methyl to decyl. They polymerize rapidly within seconds in an exothermic reaction following contact with proteinaceous surfaces to form strong and flexible bonds. Methyl cyanoacrylate was the first glue developed, but tissue toxicity precluded its use. The process of causing histologic toxicity is thought to be related to the byproducts of degradation into cyanoacetate and formaldehyde. Further research showed that changing the type of alkyl chains in the compound to one with a longer molecular chain can reduce tissue toxicity. Cyanoacrylates are simple, inexpensive and practical adhesives. Cyanoacrylates have been used for achieving hemostasis at intraoral and extra-oral surgical sites treating ulcers, attaching grafts, managing cerebral spinal fluid leaks, stabilizing the bone fragments during plating, sealing sinus membrane perforations, and achieving peripheral nerve re-anastomosis; as periodontal dressings; and for a number of other dental applications. They are sloughed from the surface of the skin and mucosa 7 to 10 days after adhesive application. Butyl cyanoacrylate is a bacteriostatic, biodegradable, hemostatic cyanoacrylate with a long half-life and good tissue compatibility. It can adhere in moist environments and is available in a formulation appropriate to be used in the oral cavity. It has been proven to be effective in closure of uninfected intraoral incisions on edentulous areas in the mandible, in extractions and periapical surgery.

Few studies are focused on evaluating the wound healing and assessing patient-centered outcomes at the palate donor area after different harvesting techniques To the best of our knowledge, there is no study that compares different methods of wound closure at the donor site.

This prospective clinical trial aims at obtaining information to determine which technique from the patient's standpoint is superior.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients of the Graduate Periodontics Clinic, College of Dentistry, University of Manitoba that require harvesting of subepithelial connective tissue graft from the palate from October 2016 to December 2017 and have signed the consent form.

排除标准

  • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy), patients on corticosteroids, patients with uncontrolled diabetes mellitus or with any systematic disease that periodontal surgery is contraindicated, and patient with history of contact dermatitis to formaldehyde will be excluded from the trial.

研究组 & 干预措施

Cyanoacrylate group

Experimental

Wound closure after harvesting of connective tissue graft in the donor site will be achieved with application of cyanoacrylate tissue adhesive

干预措施: n-butyl cyanoacrylate and 2-octyl cyanoacrylate (Device)

Suture group

Active Comparator

Wound closure after harvesting of connective tissue graft in the donor site will be achieved with polytetrafluoroethylene (PTFE) continuous interlocking sutures

干预措施: 5-0 Polytetrafluoroethylene (PTFE) suture (Device)

结局指标

主要结局

Patient's discomfort from the donor site

时间窗: During the first week after the surgery

VAS questionnaire

次要结局

  • Operative time(A baseline-during the surgery)
  • Pain from the donor site(one day after the surgery)
  • Pain from donor site(During the first week after the surgery)
  • Painkillers intake(during the first week after the surgery)
  • modified EHI early-wound healing index(one week post-operatively)
  • Complications(one week post-operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chrysi Stavropoulou

Periodontics Resident

University of Manitoba

研究点 (2)

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