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临床试验/NCT05765240
NCT05765240Enrolling By Invitation1 期

Comparison of the Effects of Topical Hyaluronic Acid and Laser Application on Healing in Children After Tooth Extraction

Atlas University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
1
主要终点
Wound healing

研究概览

简要总结

Tooth extraction is one of the major surgical procedures that can cause dental anxiety and dental fear in pediatric patients as a result of traumatic experiences. Preventing pain and infection by appropriate means during and after this application increases patient comfort and helps to develop patient cooperation for possible future dental experiences.

In the current literature, it has been shown that topical hyaluronic acid applications have a role in reducing infection and pain.

There are also studies in the literature showing that tissue biostimulation with different doses of diode laser application accelerates wound healing by promoting cell regeneration.

Although there are studies showing that two different applications accelerate wound healing, there is no study comparing the effectiveness of these two methods. In addition, there is no study evaluating extraction wound healing in pediatric patients.

Our study will be the first to evaluate tooth extraction wound healing in pediatric patients and to compare these two methods.

详细描述

Sample Size:

Our study will include 60 children aged between 5-13 years who are systemically healthy and volunteer to participate in the study, with indications for extraction of primary or permanent molars for various reasons.

In the study, the GPOWER 3.1 package program was used to determine the sufficient sample volume.

Steps followed when calculating sample volume;

1st type margin of error (α) = 0.05 The mean (1.72) and standard deviation (1.14) values of the 7th day VAS scores of the participants in the "control" group were taken into account.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Being systemically healthy
  • Having at least one primary or permanent molar extraction indication
  • The fact that at least 1/3 of the primary tooth root with an extraction indication has not been resorbed
  • Have not used antibiotics in the last 6 months

排除标准

  • Presence of systemic disease
  • Deciduous teeth with highly resorbed roots
  • Use of antibiotics in the last 6 months

研究组 & 干预措施

Group 1

Experimental

Hyaluronic acid gel will be applied to the extraction site of the patients in group 1 immediately after the extraction.

干预措施: Hyaluronic Acid Topical Gels (Drug)

Group 2

Experimental

Alveolar socket in group 2, will ve irradiated with an energy dose of J/cm2, 20mW/670 nm potency and 4 for 7 minutes immediately after extraction.

It will be irradiated with an energy dose of J/cm2.

干预措施: Diode Laser Biostimulation (Procedure)

结局指标

主要结局

Wound healing

时间窗: One month

Healing index of Landry will be used

次要结局

  • Post-operative pain(Two weeks)

研究者

发起方
Atlas University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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