Effect of Various Intracanal Medicaments on the Incidence and Intensity of Post Operative Pain in Patients with Diabetes Mellitus : A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- pain levels measured and compared
研究概览
简要总结
The aim of present randomized double blinded clinical trial is to evaluate the incidence and intensity of postoperative pain in patients with diabetes following root canal treatment for teeth with Symptomatic Irreversible Pulpitis in relation to the effects of Calcium Hydroxide, Dexamethasone, Diclofenac, Triple Antibiotic Paste used as intracanal medicament.
OBJECTIVES
-
To evaluate the effect of Diclofenac as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
-
To evaluate the effect of Dexamethasone as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
-
To evaluate the effect of Triple Antibiotic Paste as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
-
To evaluate the effect of Calcium Hydroxide as an intracanal medicament on the postoperative pain after endodontic treatment of the teeth with irreversibly inflamed pulps.
-
To evaluate the incidence and intensity of the post operative pain in each case.
-
To compare the efficacy of the above stated intracanal medicament with each other and to determine the drug of choice among these to best facilitate post operative pain in patients with diabetes.
MATERIALS AND METHODOLOGY
MATERIALS AND ARMAMENTARIUM
Diclofenac - (Diclom 50mg)
Dexamethasone –(Dexona 4mg )
Triple Antibiotic Paste ( Minocycline 100mg, Metronidazole 400mg, Ciprofloxacin 500 mg in the ratio 1:1:1)
Calcium Hydroxide
Local anaesthesia (2% lidocaine with adrenaline 1:80,000)
24gauge needle and syringe
Electric pulp tester
Endo ice
Rubber dam kit
Air rotor handpiece
Large round diamond point.
Tapered fissure diamond point
Endo access burs
Endo-Z bur
DG-16 endodontic probe
Hand files
Electronic apex locator
Endomotor
Rotary files
30gauge trunatomy double side vented irrigation needles
Endoactivator
2.5% sodium hypochlorite solution
Normal saline
EDTA
Absorbent paper points
Gutta percha points
Ah plus sealer
Cavit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with controlled diabetes [HbA1C levels (6-7.65%)] Mature mandibular permanent teeth with symptomatic irreversible pulpitis.
- •Teeth having sufficient tooth structure for adequate isolation.
- •No history of previous endodontic therapy.
- •No history of trauma to the involved tooth.
- •Age criteria: between 18 to 60 years.
- •Ability to understand and provide informed consent.
排除标准
- •immunocompromised patients, pregnant, lactating females.
- •Patients who have a positive history of analgesic intake within past 3 days.
- •Patients who have a positive history of antibiotics intake in the last month.
- •• Patients with known history of allergy to the drugs in study.
- •Patients with radiographic evidence periapical pathology.
- •Periodontally compromised teeth Calcified roots.
- •Patients with known history of peptic ulcers or gastrointestinal bleeding.
- •Neurologic patients.
- •• Psychiatric patients who are not able to rate the pain.
结局指标
主要结局
pain levels measured and compared
时间窗: 4hrs, 8hrs, 12hrs, 24hrs, 48hrs
次要结局
未报告次要终点
研究者
SHREYA RASHI
SGT DENTAL COLLEGE