A comparative assessment between analgesic and non analgesic coated suture material in evaluation of post extraction pain and healing : A prospective split mouth study
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To assess pain and healing in post extraction 1 day, 3 days and 7 days.
研究概览
简要总结
Wound repair is a well orchestrated and highly coordinated process. Sutures serve to maintain tissue approximation until the wound attains sufficient tensional strength to prevent dehiscence. Correct closure and stabilization of surgical wound margins influence the success of the surgical procedure. The number of tissue layers involved in wound closure, the amount of tension across the sutured wound, the depth at which the suture is placed, the presence of edema, the approximate amount of time the suture must be kept in place, and the inflammatory reactions displayed by the suture material are some of the factors that influence the choice of suture material in the management of surgical wounds. Post extraction pain has often been a nemesis for dental surgeons,with clinicians perpetually striving for an analgesic modality that would provide profound analgesia and would be best tolerated by the patient, hence ensuring patient compliance. Medications such as NSAIDS are frequently provided to patients experiencing post-surgical pain and are to be taken orally or parentarally.Long term repeated medication administrations are necessary as long term pain lasts until the wounds have nearly healed. Gastrointestinal disturbances, Electrolytic imbalance, Fluid retention hypertension, Hyperkalemia, Hyponatremia, Reye’s syndrome, Platelet dysfunction and Renal impairment are just a few of the side effects. Since oral medications must first pass through the liver for metabolism, there will be less bioavailability and due to high plasma concentration which leads to significant adverse effects, local drug delivery is advantageous for reducing pain at the surgical site. Ketorolac tromethamine is a pyrrolo -pyrrole non steroidal anti inflammatory drug with potent analgesic, anti inflammatory and antipyretic activity. Mechanism of action of Ketorolac is by inhibiting the cycloxygenase pathway of arachidonic acid metabolism, resulting in a decrease in prostaglandin and thromboxane production. Therefore, Analgesic-coated suture can be used as a medical aid potentially suitable for local drug delivery to treat post-surgical pain.
In this study, we will be comparing Analgesic coated suture- Ketorolac tromethamine and Non Analgesic coated suture Vicryl 3-0 post extraction to provide local drug delivery to alleviate pain and assess healing in patients by two interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients within the age of 18 – 60 years.
- •2.Patients with any bilateral symmetrical extractions.
- •3.Patients who are medically fit for the procedure.
排除标准
- •Patients who are not willing to participate in the study.
- •Pregnant or lactating mothers.
- •3.Patients with immunocompromised conditions and systemic diseases.
- •4.Clinical evidence of acute infection, inflammation or any other pathologies like periapical cyst, tumours, fractures etc.
- •around the tooth to be extracted for the study.
- •5.Patients who are allergic to the analgesic drug.
结局指标
主要结局
To assess pain and healing in post extraction 1 day, 3 days and 7 days.
时间窗: To assess pain and healing in post extraction 1 day, 3 days and 7 days.
次要结局
- To assess better quality of life in these patients by fore-said parameters(Follow up of 7 days)
研究者
Dr Deeyah Miriam Deepak
Yenepoya Dental College
