Comparative Analysis of Postoperative Pain Following Single vs Multiple-Visit Root Canal Therapy in Single-Rooted Teeth of Diabetic Patients: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- College of Physicians and Surgeons Pakistan
- 入组人数
- 200
- 主要终点
- Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation
概览
简要总结
A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.
详细描述
This study compares post-treatment pain after root canal therapy done in one visit versus two visits for patients with diabetes. Root canal treatment can sometimes cause pain afterwards, and it is unclear if the number of visits makes a difference, especially for diabetic patients who may have different healing and pain responses. We will randomly assign 200 diabetic patients needing a root canal on a single-rooted tooth to either have the entire procedure completed in a single appointment or split over two appointments. Patients will record their pain levels on a standard scale at 24 hours, 72 hours, and one week after the procedure. We hypothesize that there will be no significant difference in pain levels between the two treatment approaches. The results will help dentists decide the best treatment plan for their diabetic patients without worrying about causing more pain.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 12 and 60 years.
- •Diagnosed with Type 1 or Type 2 Diabetes Mellitus.
- •In need of root canal treatment on a single-rooted tooth.
- •A clinical diagnosis of either irreversible pulpitis or necrotic pulp in the indicated tooth.
- •Willingness and ability to understand and provide written informed consent (and assent with parental consent for minors).
排除标准
- •Pregnancy.
- •Known history of allergy to local anesthetics.
- •Presence of large periapical radiolucent lesions (typically defined as \>5mm in diameter).
- •Current use of long-term analgesic or anti-inflammatory medication (which could alter pain perception).
- •Teeth with complex root canal anatomy (e.g., calcified canals, C-shaped canals) that would complicate standard treatment.
研究组 & 干预措施
Single-Visit RCT
Participants in this arm receive the complete root canal therapy procedure in a single clinical appointment. This includes local anesthesia, rubber dam isolation, access cavity preparation, biomechanical cleaning and shaping of the root canal system, and final obturation (filling) of the canal
干预措施: Single-Visit Root Canal Therapy (Procedure)
Multiple-Visit RCT
Participants in this arm receive root canal therapy over two separate appointments. The first visit includes local anesthesia, rubber dam isolation, access cavity preparation, and biomechanical cleaning and shaping of the root canal system, followed by the placement of an intracanal medication and a temporary restoration. The second visit involves the removal of the temporary material and the final obturation (filling) of the canal
干预措施: Single-Visit Root Canal Therapy (Procedure)
Multiple-Visit RCT
Participants in this arm receive root canal therapy over two separate appointments. The first visit includes local anesthesia, rubber dam isolation, access cavity preparation, and biomechanical cleaning and shaping of the root canal system, followed by the placement of an intracanal medication and a temporary restoration. The second visit involves the removal of the temporary material and the final obturation (filling) of the canal
干预措施: Multiple-Visit Root Canal Therapy (Procedure)
结局指标
主要结局
Incidence of Moderate-to-Severe Pain at 24 Hours Post-Operation
时间窗: 24 Hours after the procedure
Measurement Tool: Numeric Rating Scale (NRS), an 11-point scale from 0 (no pain) to 10 (worst imaginable pain). Unit of Measure: Percentage (%) of patients. Description: The proportion of patients reporting a pain intensity score of 4 or greater on the NRS during movement (e.g., coughing or ambulation) at the 24-hour post-operative time point.
次要结局
- Mean Resting Pain Intensity at 24 Hours Post-Operation(24 hours after the procedure)
研究者
Faiz ur rahman
Postgraduate Resident, Department of Operative Dentistry
College of Physicians and Surgeons Pakistan