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临床试验/NCT06823544
NCT06823544尚未招募2 期

A Comparative Single Blind Clinical Study on the Effect of Alvogyl, Eugenol, and Nigella Sativa (Black Seed Oil) for Alveolar Osteitis.

HITEC-Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction.

Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three.this study aims to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.

详细描述

Dry socket the unscientific term also known as alveolar or fibrinolytic osteitis is the most common postoperative complication following tooth extraction. Dry socket lesion occur in approximately 1% to 5% of all extraction and up to 38% of mandibular third molar extractions. The etiology of dry socket is not yet fully understood, however the disintegration of the blood clot at the site of the tooth extraction fails to develop i.e. fibrinolysis is widely accepted as the primary mechanism or it dislodges before wound has healed. Various factors have been associated with an increase of dry socket, although some of them remain controversial and many include difficult or traumatic extractions, oral hygiene, smoking, Gender (female), extraction site, previous dry socket history, while incidence can be reduced with the chlorhexidine rinse and gel of alveolar osteitis.

Treatment of Alveolar osteitis can be either pharmacological on non-pharmacological. Management can be by irrigation, surgical intervention and placement of medicated dressing such as topical anti-bacterial, topical anesthetics and obtundants or combination of these three. Out of these Alveogyl is the still the material of choice in terms of pain relief, wound healing and low incidence of dry socket as compared to honey, zinc oxide eugenol and cutanplast , however in some recent studies a mixture of Nigella sativa powder and oil showed that it is more efficacious dressing material for the management of dry socket compared to alvogyl, it provided immediate and complete pain relief and fewer number of repeated visits needed while in some neocane was the most suitable dressing material for the management of dry socket by virtue of shorter time required for the complete pain relief, fewer visits required and faster clinical healing. Based on the previous data, we decided to conduct a study to evaluate the effectiveness of nigella sativa (black seed oil) for the treatment of dry socket compared to alveogyl and eugenol both. To the best of our knowledge, this is the first comparative study of nigella sativa oil for the treatment of dry socket at Oral and maxillofacial surgery department, HITEC dental college, Taxila and is aimed to find the best and effective treatment for dry socket comparing Alveogyl, Eugenol and Black seed oil at this institution.

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
Single (Participant)

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over the age of 16, from both genders, who had their teeth extracted and were clinically diagnosed with dry socket.
  • Absence of systematic disease.

排除标准

  • Patients under the age of 16 years and over the age of 70 years
  • Patient with various bone diseases including osteoporosis.
  • Patients who had a history of taking oral or intravenous bisphosphonates.
  • Patients with a history of radiotherapy to the head and neck and jawbones.

研究组 & 干预措施

Alvogyl

Experimental

this group will be assigned Alvogyl as treatment drug

干预措施: Alvogyl (Drug)

Eugenol

Experimental

this group will be assigned Eugenol as treatment drug

干预措施: Eugenol (Drug)

Black Seed Oil

Experimental

this group will be assigned Nigella Sativa as treatment drug

干预措施: Nigella Sativa Oil (Drug)

结局指标

主要结局

Visual Analogue Scale

时间窗: 14 days

pain will assessed using Visual Analogue scale on day 2, 6, 10 and 14th after the start of treatment. Visual Analogue Score measurement will be scale based from 1 to 10 score. Where 1-3 is mild, 3-7 is moderate and 7-10 will be scored as severe pain.

Periodontal Probe

时间窗: 14 days

alveolar osteitis affected extraction socket will be observed for the resolution of inflammation and healing will be assessed on day 2, 6, 10 and 14 by clinical examination with periodontal Probe. Periodontal depth will be measured in mm, by using the periodontal probe where the depth of 1 to 3 mm is considered well healed socket, 4-6 mm indicates moderately inflamed, 7 mm and above is considered severely inflammed .

次要结局

未报告次要终点

研究者

发起方
HITEC-Institute of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammad Bilal

Principal Investigator

HITEC-Institute of Medical Sciences

研究点 (1)

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