The efficacy of sublingual and intravenous injection of dexamethasone on pain, trismus and swelling after surgical removal of impacted mandibular third molars: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The efficacy of dexamethasone administration through intravenous and sublingual routes on pain using VAS scale, Swelling using Schultze-Mosgau method and mouth opening by interincisal measurement in impacted mandibular third molar surgeries
研究概览
简要总结
Various methods of administering dexamethasone in third molar surgery have been proposed. Intravenous (IV) injection requires additional clinical expertise, and administering IV dexamethasone in conscious patients may lead to transient perineal irritation (itching, burning, or squeezing sensation) in some individuals. Additionally, a single IV injection of dexamethasone can spread widely throughout the body, potentially resulting in less than optimal effectiveness at the injury site.
The sublingual route has advantage of not causing additional postoperative pain for patients when administered following common dental interventions like the inferior alveolar nerve block, lingual nerve block and long buccal nerve block typically performed in mandibular third molar procedures. This method is straightforward and easily manageable for dentists.
In present study, the effectiveness of dexamethasone administered via sublingual versus intravenous routes will be assessed, the outcome of this study will help the dental surgeons to choose the appropriate route of administration of dexamethasone.
Under strict aseptic conditions, patients will be prepared for the surgical procedure. A classical inferior alveolar nerve block, along with lingual and long buccal nerve block will be administered. After 5 minutes, patients in Group A will receive 8 mg dexamethasone intravenously injected into either the median cubital or radial vein, whereas, patients in Group B will receive 8 mg injection dexamethasone into sublingual space. Time taken to administer dexamethasone through both the routes will be noted using timer. Utilizing a standard Ward’s incision, access will be gained, and the tooth will be extracted after necessary bone cutting and tooth splitting, ensuring minimal tissue trauma. Post-extraction, the socket will be thoroughly irrigated with a 5% povidone-iodine solution diluted with equal proportion of normal saline. The flap will then be sutured back using two interrupted sutures of 3-0 BBS (Black Braided Silk). Follow-up appointments will be scheduled for all patients on first,second,third and seventh postoperative days. Suture removal will be carried out on the seventh postoperative day if the healing is assessed to be satisfactory.
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 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with impacted lower third molars symmetrically placed on mandible, which requires surgical removal by flap reflection, bone guttering and tooth sectioning.
- •Healthy patients (ASA I).
- •Patients who are willing to take part in study.
排除标准
- •1.Patients on long-term steroids.
- •2.Pregnant and lactating women.
- •3.Patients with acute infection and trismus.
- •4.Patient allergic to local anesthetics and other drugs that will be used in this study.
- •5.Patient with facial deformities that may hinder injections, surgery or evaluation.
- •6.Patients with cardiovascular problems, renal and/or liver failure, or other severe medical conditions.
- •7.Not being able to follow instructions or cooperate during study.
结局指标
主要结局
The efficacy of dexamethasone administration through intravenous and sublingual routes on pain using VAS scale, Swelling using Schultze-Mosgau method and mouth opening by interincisal measurement in impacted mandibular third molar surgeries
时间窗: Postoperative day 1,2,3 and 7
次要结局
- Any effect on quality of life(1 week)
研究者
Dr Sreelekshmi J
KVG Dental College and Hospital
