Effect of Intracanal Cryotherapy and Metformin on Postoperative Pain in Teeth With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Spontaneous postoperative pain on days 1 to 7
研究概览
简要总结
This randomized, participant- and outcome assessor-blinded, 2 × 2 factorial clinical trial evaluated the effects of intracanal cryotherapy and two intracanal medicaments-calcium hydroxide and metformin-on postoperative spontaneous and percussion pain in mandibular premolars with pulpal necrosis and symptomatic apical periodontitis. Eighty participants were randomly assigned to four groups: calcium hydroxide, metformin, cryotherapy plus calcium hydroxide, and cryotherapy plus metformin. All teeth underwent standardized two-visit root canal treatment. In the cryotherapy groups, final irrigation at the first treatment visit was performed using sterile saline at 4 °C. Spontaneous pain was assessed preoperatively and daily for 7 postoperative days using a 100-mm visual analog scale (VAS). Percussion pain was assessed preoperatively and on day 7 immediately before the second treatment visit. The effects of cryotherapy, intracanal medicament type, and their interaction were evaluated using mixed-effects modeling for spontaneous pain and analysis of covariance (ANCOVA) for day-7 percussion pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were masked to treatment allocation. The operator was masked to intracanal medicament assignment; however, complete operator masking to cryotherapy allocation could not be guaranteed because of the temperature difference between the irrigation solutions.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy participants. Mandibular premolar teeth diagnosed with pulpal necrosis and symptomatic apical periodontitis and indicated for root canal treatment.
- •Periapical index (PAI) score of 1 or
- •Aged between 18 and 70 years. Able to understand and complete visual analog scale (VAS) assessments. Provided written informed consent.
排除标准
- •Any systemic disease or pregnancy. Use of analgesics within 24 hours prior to treatment. Severe bruxism. Presence of acute apical abscess or swelling. Periodontal pocket depth greater than 5 mm or tooth mobility exceeding grade
- •Teeth deemed unrestorable. Presence of vital pulpal tissue or immature apices. Radiographic evidence of root resorption, root fracture, perforation, or canal calcification.
研究组 & 干预措施
Intracanal Cryotherapy and Calcium Hydroxide
干预措施: Application of calcium hydroxide as an intracanal medicament together with intracanal cryotherapy (Drug)
Intracanal Cryotherapy and Metformin
干预措施: Application of metformin into the canal together with intracanal cryotherapy (Drug)
Calcium Hydroxide
干预措施: Placement of calcium hydroxide as an intracanal medicament (Drug)
Metformin
干预措施: Placement of metformin as an intracanal medicament (Drug)
结局指标
主要结局
Spontaneous postoperative pain on days 1 to 7
时间窗: Days 1 through 7 post-treatment
Spontaneous postoperative pain assessed daily from day 1 to day 7 using a Visual Analog Scale (VAS). Preoperative VAS score is used as a covariate in the statistical analysis.
次要结局
- Day-7 percussion pain(Day 7 post-treatment)
研究者
Celalettin Topbaş
ASSOCIATE PROFESSOR
Saglik Bilimleri Universitesi