Effect of Different Irrigation Protocols on Postoperative Pain Following Regenerative Endodontic Treatment: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Measured Using a Numerical Rating Scale
研究概览
简要总结
This randomized clinical trial evaluated the effect of two different irrigation solutions on postoperative pain following regenerative endodontic treatment of necrotic immature permanent teeth with apical periodontitis. Participants were randomly allocated to receive either 0.1% octenidine dihydrochloride (OCT) or 17% ethylenediaminetetraacetic acid (EDTA) during regenerative endodontic treatment.
A total of 40 patients aged 9 to 16 years were included and allocated to the two intervention groups in a 1:1 ratio. Postoperative pain was recorded using a 0-100 numerical rating scale at 6, 12, and 24 hours and daily from the second through the seventh postoperative day. Analgesic use and the occurrence of flare-up were also evaluated.
详细描述
Necrotic immature permanent teeth with apical periodontitis present a clinical challenge because incomplete root development is associated with thin dentinal walls, an open apex, and an increased risk of root fracture. Regenerative endodontic treatment is a biologically based procedure that aims to control intracanal infection, promote healing of the periapical tissues, and allow continued root development.
Successful regenerative endodontic treatment requires effective root canal disinfection while preserving an environment that supports the survival and activity of stem cells from the apical papilla. Ethylenediaminetetraacetic acid (EDTA) is commonly used in regenerative procedures because of its chelating properties, its ability to modify the dentin surface, and its potential to promote the release of dentin-derived bioactive molecules. Octenidine dihydrochloride (OCT) is a broad-spectrum antiseptic that has demonstrated antimicrobial activity and potentially favorable biological effects on dental-derived stem cells. However, clinical evidence regarding the use of OCT during regenerative endodontic treatment remains limited.
This prospective, participant-blinded, parallel-group randomized clinical trial included 40 systemically healthy patients aged 9 to 16 years who had a necrotic immature permanent tooth with apical periodontitis. Eligible teeth had Cvek stage 2 or 3 root development and a baseline Periapical Index score between 2 and 4. Each participant contributed one tooth to the study.
Participants were randomly assigned in a 1:1 ratio to one of two irrigation groups:
- The OCT group received 0.1% octenidine dihydrochloride.
- The EDTA group received 17% ethylenediaminetetraacetic acid.
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)
盲法说明
This was a participant-blinded trial. Participants were not informed of the irrigant assigned to their treatment. The treating clinicians could not be blinded because they administered the allocated irrigant. Postoperative pain was self-recorded by the participants using standardized forms, and intervention group codes were concealed during statistical analysis.
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy status classified as American Society of Anesthesiologists class I;
- •An immature permanent tooth with pulp necrosis and apical periodontitis;
- •Cvek stage 2 or 3 root development;
- •Preoperative pain below 40 on a 0-100 numerical rating scale (NRS);
- •A baseline Periapical Index (PAI) score between 2 and 4;
- •A tooth considered restorable and suitable for RET; and
- •Willingness of the participant and legal representative to comply with postoperative assessment and follow-up requirements.
排除标准
- •systemic disease
- •bruxism or another parafunctional habit
- •had used analgesics within 12 hours before treatment
- •severe root canal curvature
- •vertical root fracture
结局指标
主要结局
Postoperative Pain Intensity Measured Using a Numerical Rating Scale
时间窗: At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit
Postoperative pain intensity was self-recorded by participants using a numerical rating scale ranging from 0 to 100, where 0 indicated no pain and 100 indicated the worst pain imaginable. Higher scores indicated greater postoperative pain intensity. Pain scores were recorded after the second regenerative endodontic treatment visit.
次要结局
- Postoperative Analgesic Consumption(At 6, 12, and 24 hours and daily from Day 2 through Day 7 after the second treatment visit)
研究者
Busranur Yavuz
ARŞ.GÖR
TC Erciyes University