Comparison of Postoperative Pain After Root Canal Irrigation, With and Without Dexamethasone, for Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity measured using the Visual Analogue Scale (VAS)
研究概览
简要总结
This randomized controlled trial will compare postoperative pain following root canal treatment in patients with symptomatic irreversible pulpitis. The study will evaluate whether using dexamethasone as the final intracanal rinse provides better pain control than normal saline.
Patients requiring two-visit root canal treatment for symptomatic irreversible pulpitis will be randomly assigned to receive either dexamethasone or normal saline as the final rinse during root canal treatment. All participants will otherwise receive the standard root canal treatment protocol.
Postoperative pain will be assessed using a Visual Analog Scale (VAS) at the specified follow-up time points after treatment. Pain scores between the two groups will be compared to determine whether the addition of dexamethasone as a final intracanal rinse reduces postoperative pain.
详细描述
Postoperative pain is a common concern following root canal treatment and may persist because of inflammation associated with the treatment of symptomatic irreversible pulpitis. Although corticosteroids such as dexamethasone have established anti-inflammatory effects, limited information is available regarding their use specifically as a final intracanal rinse during root canal treatment.
This study will evaluate the effect of dexamethasone used as a final intracanal rinse on postoperative pain in patients with symptomatic irreversible pulpitis undergoing two-visit root canal treatment. Participants will be randomly allocated to one of two parallel groups. The dexamethasone group will receive dexamethasone as the final intracanal rinse, whereas the control group will receive an equal volume of normal saline.
Both groups will undergo the same conventional endodontic treatment protocol, with sodium hypochlorite used during canal irrigation. In the intervention group, 1 mL of dexamethasone solution (4 mg/4 mL) will be used as the final rinse, while the control group will receive 1 mL of normal saline as the final rinse. The root canal treatment will be completed at the second appointment one week after the first visit.
Postoperative pain will be assessed using a 10-point Visual Analog Scale, with higher scores indicating greater pain intensity. The pain scores of participants receiving dexamethasone will be compared with those receiving normal saline to determine whether dexamethasone as a final intracanal rinse is associated with reduced postoperative pain.
The study will be conducted as a two-arm, parallel randomized controlled trial at the Department of Operative Dentistry, Institute of Dentistry, CMH Lahore Medical College. A total of 72 participants will be enrolled, with 36 participants allocated to each study group.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and the outcome assessor assessing postoperative pain will be blinded to treatment allocation. The treating operator will not be blinded because the final irrigants differ in composition.
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
- •Adults aged 18-65 years.
- •Patients diagnosed with symptomatic irreversible pulpitis in a maxillary or mandibular premolar or molar.
- •Positive response to cold/thermal pulp testing and electric pulp testing.
- •Clinical features consistent with symptomatic irreversible pulpitis, including spontaneous pain and/or pain elicited by thermal stimuli, with clinically evident deep carious involvement or pulpal exposure.
- •Patients indicated for two-visit root canal treatment.
- •Ability to understand and complete the Visual Analogue Scale (VAS) for pain assessment.
- •Absence of active periodontal disease.
排除标准
- •Use of analgesics, antibiotics, or anti-inflammatory medications within 24 hours before treatment.
- •History of chronic pain.
- •Evidence of periapical involvement or pathology, including periapical abscess, sinus tract, or periapical cyst.
- •Pulp necrosis.
- •Internal or external root resorption.
- •Unfavourable tooth position, ankylosis, trismus, or significant malposition associated with traumatic occlusion.
- •Immunocompromised status.
- •Known allergy or contraindication to local anaesthetic or dexamethasone.
- •Previous endodontic treatment of the study tooth.
- •Non-restorable teeth or unfavourable crown-to-root ratio.
- •Inability to understand or reliably use the VAS.
- •Inability or unwillingness to attend follow-up assessments.
研究组 & 干预措施
Normal Saline Final Rinse
Participants will receive conventional root canal irrigation with saline and 3% sodium hypochlorite, followed by 1 mL of normal saline as the final intracanal rinse before obturation. Root canal treatment will be performed over two visits according to the standardized study protocol.
干预措施: Sodium Chloride 0.9% (Drug)
Dexamethasone Final Rinse
Participants will receive conventional root canal irrigation with saline and 3% sodium hypochlorite, followed by 1 mL of dexamethasone solution (4 mg/4 mL; 1 mg/mL) as the final intracanal rinse before obturation. Root canal treatment will be performed over two visits according to the standardized study protocol.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Postoperative pain intensity measured using the Visual Analogue Scale (VAS)
时间窗: 24 hours, 48 hours, and 7 days after root canal treatment
Postoperative pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable. Pain scores will be recorded at 24 hours, 48 hours, and 7 days after root canal treatment and compared between the dexamethasone and normal saline groups.
次要结局
未报告次要终点