The Effect of Nonsurgical Endodontic Retreatment on Postoperative Pain in Patients With Diabetes Mellitus: A Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity assessed using the 100-mm Visual Analog Scale (VAS)
研究概览
简要总结
ABSTRACT This prospective, controlled, single-center clinical study aims to compare postoperative pain levels and analgesic consumption after nonsurgical endodontic retreatment in individuals with diabetes mellitus and systemically healthy individuals. In addition, the study aims to evaluate the relationship between HbA1c levels, type of antidiabetic medication, and postoperative pain within the diabetes mellitus group.
A total of 54 patients with single-rooted teeth requiring nonsurgical endodontic retreatment due to persistent endodontic problems following previous root canal treatment will be included. Participants will be allocated into two groups according to systemic status: a diabetes mellitus group and a systemically healthy control group, with 27 patients in each group.
All retreatment procedures will be performed by a single operator using a standardized clinical protocol. Previous root canal filling materials will be removed, root canals will be reshaped, irrigated according to a standardized irrigation protocol, and obturated using an epoxy resin-based root canal sealer and gutta-percha cones with the cold lateral condensation technique.
Postoperative pain will be assessed using a Visual Analog Scale at 6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7. Analgesic consumption will be recorded at the same follow-up time points. Intergroup comparisons, changes in pain scores over time, and associations between HbA1c levels, antidiabetic medication type, and postoperative pain will be evaluated using appropriate statistical tests. The statistical significance level will be set at p < 0.05.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18 to 60 years. Patients classified as medically healthy (ASA I) for the control group or as having diabetes mellitus (ASA II or ASA III) for the diabetes mellitus group.
- •Single-rooted, single-canal teeth with closed apices. Teeth with previous root canal treatment completed at least 4 years before enrollment.
- •Teeth with root canal filling ending 1 to 4 mm coronal to the radiographic apex.
- •Teeth diagnosed with asymptomatic apical periodontitis. Teeth with a periapical index score between 2 and
- •Teeth without pain on percussion or palpation. Teeth not requiring periodontal or prosthetic treatment. Teeth suitable for rubber dam isolation.
排除标准
- •Use of analgesics, antibiotics, or corticosteroids within the last 2 weeks before nonsurgical endodontic retreatment.
- •Teeth with periodontal attachment loss. Teeth with vertical root fracture, external root resorption, or perforation. Teeth with fractured prosthetic restorations. Non-restorable teeth. Patients with severe pain and/or acute apical abscess. Pregnant patients. Teeth with calcified root canals. Individuals considered unable to comply with treatment procedures because of intellectual disability, developmental delay, or advanced age.
结局指标
主要结局
Postoperative pain intensity assessed using the 100-mm Visual Analog Scale (VAS)
时间窗: 6, 12, 24, and 48 hours after nonsurgical endodontic retreatment and on postoperative days 3, 4, 5, 6, and 7
Postoperative pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS). The VAS ranges from 0 to 100 mm, where 0 indicates no pain and 100 indicates the worst imaginable pain. Higher scores indicate greater postoperative pain intensity. Pain will be recorded at each scheduled follow-up assessment.
次要结局
- Analgesic consumption after nonsurgical endodontic retreatment(6, 12, 24, and 48 hours after treatment and on postoperative days 3, 4, 5, 6, and 7.)
- Association between HbA1c level and postoperative pain intensity(HbA1c level assessed at baseline; postoperative pain assessed at 6, 12, 24, and 48 hours and on postoperative days 3, 4, 5, 6, and 7.)
研究者
Ipek Eraslan Akyuz
Dr.
TC Erciyes University