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临床试验/NCT06112366
NCT06112366已完成不适用

Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Teeth Surgery

Yuzuncu Yıl University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Facial edema

研究概览

简要总结

This study was administered to 21 female and 9 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After extraction of the impacted teeth, silk sutures were used on one side and cyanoacrylate tissue adhesive on the other side for wound closure. The effects of these two materials on patient comfort were investigated.

详细描述

The aim of this study was to compare the effectiveness of tissue adhesive (Periacryl 90) and silk suture in bilateral mandibular impacted wisdom tooth surgery. In the study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as the experimental group, while the other tooth was selected as the control group and the wound was closed with silk suture. The selected side was determined by a closed envelope procedure. After the first impacted tooth extraction, the patient waited until the wound healed and the symptoms disappeared completely, and then the other tooth was extracted. Both extractions were evaluated on days 3 and 7 for wound healing, edema and trismus. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteers with bilateral fully impacted mandibular wisdom teeth

排除标准

  • Patients were excluded from the study if they did not understand the clinical procedures of the study,
  • Had allergies or intolerance to any of the substances used in the study,
  • Patients on anticoagulant or psychiatric treatment,
  • Pregnant or breastfeeding,
  • Patients using oral contraceptiveswere,
  • Diabetic,
  • Patients with periodontal disease or active infection,
  • Poor oral hygiene

结局指标

主要结局

Facial edema

时间窗: 0-28 days

Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.

Mouth opening measurements

时间窗: 0-28 days

The distance between the incisals of the patient's central teeth at maximal mouth opening.

Visual Analog Scale

时间窗: 0-28 days

A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.

Wound healing

时间窗: 0-28 days

View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.

次要结局

未报告次要终点

研究者

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

Serap Keskin Tunc

Associate Professor Serap Keskin Tunc

Yuzuncu Yıl University

研究点 (2)

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