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临床试验/CTRI/2024/10/074585
CTRI/2024/10/074585尚未招募4 期

Efficacy of haemostatic, hygroscopic and antimicrobial properties of 1 percent Feracrylum post dental extractions in medically compromised patients .

Themis Medicare Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月14日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1.Increase in rate and amount of wound closure.

研究概览

简要总结

The study aims at evaluating the haemostatic, hygroscopic and antimicrobial properties of 1% feracrylum in medically compromised patients.

The prospective clinical trial will involve patients of age 18-65 years who are planned for intra-alveolar extractions and having systemic diseases like hypertension and diabetes or on aspirin therapy. Divided into group A and B Study group and Control group respectively.

After the extraction of the tooth a gauze soaked with Themiseal 1% feracrylum will be placed on the socket for 2 minutes, and amount of bleeding will be recorded by removing the gauze and taking a photograph. Same gauze will be placed and as did earlier and photos will be taken to record bleeding at 5minutes and 10minutes after extraction. Following this, for initial assessment of WOUND CLOSURE RATE parameter a photograph was taken after 30 minutes of extraction which will be the 1st record of the wound size, proforma including all the necessary questionnaires, parameters and patient’s details will be filled and patient will be prescribed with antibiotics, analgesics for next 3 days and Themiseal mouthwash for next 7 days, In the control group the parameter will be the same just guaze placed after extraction will be saline soaked gauze and Themiseal mouthwash won’t be prescribed.

Recall of the patient will be done on 3rd, 7th and 15th day according to the study parameters which are a) Post-operative bleeding scale. b) Wound healing status. c) Visual Analogue Scale. d) Wound Closure Rate. e) Verbal rating scale. f) Asepsis wound score. For both the groups.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients planned for intra-alveolar extractions, systemic Diseases like hypertension and diabetes, patients on aspirin therapy, ASA 1 and 2.

排除标准

  • Patients with AIDS or immunosuppressive diseases; pregnant or lactating women; patients allergic to lidocaine, paracetamol or ibuprofen; patients in whom the administration of epinephrine is contraindicated, patients who presented with a jawbone-associated pathology.
  • and non-co-operative patients (psychic-motor dysfunction and behaviour disorders), ASA 3, 4 and 5.

结局指标

主要结局

1.Increase in rate and amount of wound closure.

时间窗: On the day of extraction. | 1- 3rd day after extraction. | 2- 7th day after extraction healing is best with feracrylum without any infection, and pain .

2.Decrease incidence of post –op infections without the use of strong antibiotics.

时间窗: On the day of extraction. | 1- 3rd day after extraction. | 2- 7th day after extraction healing is best with feracrylum without any infection, and pain .

3. Arrest of bleeding without any additional intervention.

时间窗: On the day of extraction. | 1- 3rd day after extraction. | 2- 7th day after extraction healing is best with feracrylum without any infection, and pain .

次要结局

  • 1.Increase in wound closure rate.(2.Decrease in chances of dry socket thus decrease in post operative pain.)

研究者

发起方
Themis Medicare Ltd
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Vaibhav Sheshrao Bibe

Meenakshi Ammal Dental College and Hospital

研究点 (1)

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