"Is Antibiotic Therapy Necessary for Patients Undergoing Extraction of Tooth With a Periapical Abscess? : A Randomised Controlled Clinical Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Assessment of the extraction socket healing of both the groups using a modified Landry's Wound Healing Index
研究概览
简要总结
This is a triple-blind randomized controlled trial conducted at the Department of Oral and Maxillofacial Surgery, Subbaiah Institute of Dental Sciences, Shimoga. The study enrolls 176 adult patients aged above 18 years belonging to ASA class 1 or 2, requiring intra-alveolar extraction of non-restorable carious teeth with radiographic evidence of periapical abscess of less than 1.5 cm in diameter. Patients are randomly allocated into two equal groups of 88 each. Group A receives postoperative Amoxicillin 500 mg thrice daily for 5 days in addition to standard analgesics. Group B receives only standard analgesics with no antibiotic prescription. The primary outcome measure is wound healing assessed on postoperative day 5 using a modified Landry Wound Healing Index evaluating gingival tissue color, response to palpation, presence of granulation tissue, and suppuration.
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
- 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
- •Patients aged above 18 years
- •Patients who are willing to participate in the study
- •Patients requiring extraction of non-restorable carious teeth with radiographic evidence of periapical abscess (< 1.5cm diameter ill-defined, diffused periapical radiolucent lesion )
- •Patients who come under ASA class 1 and 2 classification
排除标准
- •Patients requiring trans-alveolar extraction
- •Patients with known Penicillin allergy
- •Pregnant women
- •Patients undergoing antibiotic therapy perioperatively
- •Patients not complying with follow-up
结局指标
主要结局
Assessment of the extraction socket healing of both the groups using a modified Landry's Wound Healing Index
时间窗: postoperative 5th day
On postoperative day 5, a blinded investigator assesses the socket using a modified Landry's Wound Healing Index. The primary outcomes include: * Gingival Tissue Colour: Rated from "more than 50% red" to "all pink". * Response to Palpation: Presence or absence of bleeding. * Granulation Tissue: Presence or absence. * Suppuration: Presence or absence. Scores are assigned from 1 (Very Poor) to 5 (Excellent) based on these criteria. If a patient experiences pain before the follow-up, they are examined for dry socket and managed accordingly
次要结局
未报告次要终点
研究者
Suchith S Shetty
Principal Investigator
Subbaiah Institute of Dental Sciences