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临床试验/NCT04192864
NCT04192864已完成不适用

Comparison Between the Lingually Based and the Buccally Based Triangular Flap Design in the Surgical Removal of Impacted Mandibular Third Molars (Randomized Split Mouth Clinical Trial)

Nourhan M.Aly2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年10月25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
20
试验地点
2
主要终点
Postoperative Pain using Visual Analogue Scale (VAS)

研究概览

简要总结

The primary objective of this study was to compare between the lingually based triangular flap with the buccally based triangular flap in the surgical removal of impacted mandibular third molars.

详细描述

Many flap designs used for impacted third molar surgery do not place the mucoperosteal incision on sound bone, as they involve incisions that are placed on the extraction socket resulting in higher incidence of mucosal dehiscence, followed by secondary wound healing

This study involved 20 patient with bilaterally mesially angulated impacted third molar (class II position B). One side was surgically removed using the lingually based triangular flap and the other side was surgically removed using the bucally based triangular flap

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This study was a single blinded trial, where the participants did not know the technique used in each side.

入排标准

年龄范围
21 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of impacted third molar that is misally angulated and retained in bone (class II position B).

排除标准

  • Patients with a history of systemic disease (diabetes, renal failure, immunocompromised patients, cardiac patients and patients taking radiotherapy or chemotherapy )
  • Compromised dental and periodontal status
  • Heavy Smoking.
  • Pregnancy or lactation

结局指标

主要结局

Postoperative Pain using Visual Analogue Scale (VAS)

时间窗: 7 days

Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)

Postoperative Edema

时间窗: 7 days

For the objective evaluation of swelling, five distances were measured * The distance from the mandibular angle to the lateral corner of the mouth * The distance from the mandibular angle to the nasal alar curvature * The distance from the mandibular angle to the lateral canthus of the eye * The distance from the tragus to the soft tissue pogonion * The distance from the tragus to the lateral corner f the mouth

Trismus Assessment

时间窗: 7 days

Trismus was assessed by measuring the maximum inter-incisional opening (in millimeters) the distance between the incisal edge of the upper and lower central incisor using caliber.

Wound healing/ Presence of alveolar osteitis

时间窗: 21 days

The presence of alveolar osteitis (dry socket) will be determined clinically using BLUM'S criteria. Wound healing was assessed and recorded depending on the absence or presence of dehiscence, every opening along the incision will be recorded as dehiscence , dental tweezers will be used to identify it.

次要结局

未报告次要终点

研究者

发起方
Nourhan M.Aly
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nourhan M.Aly

Instructor of Dental Public Health

University of Alexandria

研究点 (2)

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