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临床试验/NCT05161403
NCT05161403Unknown不适用

The Efficacy of Hyaluronic Acid and Honey in Healing of Multiple Extraction Sockets of Primary Teeth Compared to Saline in a Group of Egyptian Children

Cairo University0 个研究点目标入组 39 人开始时间: 2022年2月22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
入组人数
39
主要终点
Wound healing size in length and width

研究概览

简要总结

This study aims to evaluate the effect of hyaluronic acid and honey compared to saline in healing of multiple extraction sockets of primary teeth in a group of children aging from Two to Seven years old.

详细描述

A dental extraction is one of the most unpleasant experiences in children, especially for those who have undergone traumatic experiences, and this is likely to reduce future visits to the dental clinic if the treatment is not managed properly.

Alveolar osteitis is one of the most common complications following dental extraction. It is considered one of the most studied complications in dentistry, and many risk factors contribute to its occurrence including being a female, young age, tobacco use, difficult or traumatic extractions, pre-existing infection, and use of vasoconstrictor in local anesthesia. Alveolar osteitis occurs during the first three days following the day of extraction, so that the socket is devoid of the blood clot, resulting in the exposure of the bare alveolar bone.

Many medicines were and are still used in treating wounds, but they are somewhat expensive.

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
None

盲法说明

Neither the operator nor the patients could be blinded due to the nature of the study, but the statistician will be blinded.

入排标准

年龄范围
2 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • • Age: from Two to Seven years old age.
  • Both genders.
  • Children with badly decayed multiple primary teeth beyond repair.
  • Treated under general anesthesia.

排除标准

  • • History of systemic disease.
  • Allergy to honey.
  • Repeatedly used honey during the previous 6 month period.

研究组 & 干预措施

Hyaluronic acid.

Active Comparator

1mm layer of hyaluronic acid on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third & seventh day after extraction of teeth.

干预措施: Hyaluronic acid (Drug)

Hyaluronic acid.

Active Comparator

1mm layer of hyaluronic acid on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third & seventh day after extraction of teeth.

干预措施: honey (Dietary Supplement)

Honey

Active Comparator

1mm layer of Honey on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third & seventh day after extraction of teeth.

干预措施: Hyaluronic acid (Drug)

Honey

Active Comparator

1mm layer of Honey on a piece of gauze will be applied directly to the sockets wound for 45 minutes at baseline and on the third & seventh day after extraction of teeth.

干预措施: honey (Dietary Supplement)

Saline

Placebo Comparator

a piece of gauze moistened with normal saline will be applied directly to the sockets wound for 45 minutes at baseline and on the third & seventh day after extraction of teeth.

干预措施: Hyaluronic acid (Drug)

Saline

Placebo Comparator

a piece of gauze moistened with normal saline will be applied directly to the sockets wound for 45 minutes at baseline and on the third & seventh day after extraction of teeth.

干预措施: honey (Dietary Supplement)

结局指标

主要结局

Wound healing size in length and width

时间窗: After one week will be calculated the size (lentgh and width) of socket

There is only one outcome (wound healing) • Multiple measurements (Digital caliper, color, palpation, presence of pus, gingival margin status). 1. Digital caliper: a device used to calculate the size of the socket (width and length) buccolingual in mesiodistal with measurement of mm. 2. Color: normal (pinkish gingiva) Up normal (reddish gingiva) 3. Palpation: if there is bleeding or not. 4. Presence of pus: yes or no 5. Gingival margin: epithelization (yes or no)

次要结局

未报告次要终点

研究者

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

Anas Rahima

Principal Investigator

Cairo University

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