NCT07330726尚未招募3 期
The Efficacy of a Transmucosal Lidocaine Patch on Postoperative Pain Following Mandibular Third Molar Extraction
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 21
- 主要终点
- Pain intensity
研究概览
简要总结
- Completed medical and dental history will take for all patients and the position of the impacted teeth will evaluate by panoramic films. Patients will fully inform about the treatment procedures, follow-up examinations and complications of surgical procedures.
- Full thickness mucoperiosteal flap will be raised to expose sufficient bone on lateral and distal aspect of the impacted molar. Removal of bone will be done with stainless steel bur under Constant irrigation with normal saline while removing bone to prevent thermal necrosis.
- When necessary, sectioning of crown and roots will be performed with a fissure bur. After tooth extraction, the alveolus will be inspected, curetted, and irrigated with 0.9% sterile saline solution.
- Surgical removal of impacted mandibular third molar will be done,1% metformin gel or placebo gel in the socket following removal of the impacted third molar .
- The mucoperiosteal flap will be repositioned and sutured with 3-0 black silk suture.
- Control side : use transmucosal placebo patch
- Study side: use transmucosal lidocaine patch Postoperative care
- Postoperatively, the patients were instructed to apply ice bags 20 min/hour for the next 6 hours to the surgical side, eat soft cold diet by the aid of a straw and to avoid hot diet and fluid on the day of surgery.
- Sutures were removed after 7 days postoperatively.
- All the patients will be evaluated on the 1st, 3rd, and 7th postoperative days for pain, preoperative and postoperative mouth opening, and degree of postoperative swelling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥18ys
- •no systemic disease
- •impacted mandibular third molar class II position B on Pell- Gregory classification
排除标准
- •• history of metabolic or systemic diseases affecting bone or healing process,
- •local infection,
- •tobacco use,
- •oral contraceptive,
- •pregnancy and lactation
- •patients who had taken analgesics or anti-inflammatories for 1 week prior to enrollment in the study.
研究组 & 干预措施
lidocaine patch
Experimental
干预措施: Lidocaine patch (Drug)
placeboo patch
Placebo Comparator
干预措施: placebo patch (Drug)
结局指标
主要结局
Pain intensity
时间窗: 7 days postoperative
Pain was assessed using a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10).
次要结局
未报告次要终点
研究者
Shaimaa Mohsen
associate professor
Fayoum University
相似试验
尚未招募
不适用
Targeted Lidocaine Infusion for Pain Reduction in Office HysteroscopyNCT07318285YAARA TABIB208
招募中
不适用
Distolingual Infiltration Verses Conventional Nerve Block in Mandibular Third Molar ExtractionNCT07296926Watim Medical & Dental College120
尚未招募
不适用
Nebulized Lidocaine vs 3% Sodium Chloride in Pediatric Adenoid/Tonsil SurgeryNCT07267897Sakarya University90
尚未招募
4 期
Prevenir el dolor en las primeras 24-48h después de una cirugía de la mama. Se aplica inyectando con jeringa a nivel local, un anestésico llamado lidocaína en la zona de la cicatriz quirúrgica2025-521162-10-00Consorci Sanitari Integral128
招募中
不适用
Efficacy and Safety Evaluation Study of Implants With Periodontal LigamentDental CariesNCT07302581OrganTech, Inc.6