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临床试验/NCT05850819
NCT05850819已完成不适用

Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial

Melaka Manipal Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Postoperative wound healing

研究概览

简要总结

This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.

详细描述

In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it.

In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.

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

入选标准

  • Patients requiring extraction of mandibular teeth
  • Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
  • Patients not allergic to the drugs or anesthetics used in the study.

排除标准

  • Patients taking medications that influences wound healing
  • Uncooperative patients
  • Patients requiring extraction of grade II or III mobile teeth
  • Patients requiring surgical extraction of teeth.

研究组 & 干预措施

Group A

Experimental

Application of Gelatamp in the extraction socket

干预措施: Colloidal silver gelatin sponge (Drug)

Group B

Active Comparator

Extraction socket allowed to heal without application of Gelatamp

干预措施: Sterile gauze pack (Drug)

结局指标

主要结局

Postoperative wound healing

时间窗: 7th postoperative day

A 5 point early wound healing scale assessing wound healing after 7 postoperative days

postoperative pain

时间窗: 5th postoperative day

A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

Postoperative pain

时间窗: 2nd postoperative day

A 100 mm visual analogue scale assessing postoperative pain. Possible pain scores ranges from 0 (worst pain) to 100 (worst possible pain).

次要结局

  • Presence of dry socket(3rd postoperative day)

研究者

发起方
Melaka Manipal Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdul Kalam Azad

Assistant Professor

Melaka Manipal Medical College

研究点 (1)

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