Evaluation of the Relationship Between PGE2, NGF, and Postoperative Pain in Patients With and Without Intracanal Cryotherapy in Single-visit Endodontic Retreatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity (VAS score)
研究概览
简要总结
This prospective, randomized, controlled, single-blind, parallel-group clinical trial evaluates whether intracanal cryotherapy reduces postoperative pain and inflammatory biomarker levels following single-visit endodontic retreatment of teeth with asymptomatic apical periodontitis. A total of 100 patients (18-65 years, systemically healthy, ASA I-II) requiring non-surgical retreatment of a single-rooted mandibular premolar tooth will be randomly assigned via computer-generated randomization to one of two equal groups (n=50 each): a cryotherapy group, receiving intracanal final irrigation with sterile saline cooled to 2.5°C for 5 minutes, and a control group, receiving the same irrigation protocol with saline at room temperature (20-22°C). Salivary nerve growth factor (NGF) and gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels will be measured by ELISA at baseline (T0), 24 hours (T1), and 72 hours (T2). Postoperative pain will be assessed using a visual analog scale (VAS, 0-100 mm) at 6, 12, 24, 48, and 72 hours and on day 7, with the 24-hour VAS score as the primary comparison point. Rescue analgesic (paracetamol) consumption will also be recorded and compared between groups. The study aims to determine whether intracanal cryotherapy lowers postoperative pain and biomarker levels compared to standard-temperature irrigation, and to evaluate the correlation between PGE2/NGF levels and pain intensity.
详细描述
Postoperative pain following endodontic retreatment is associated with periapical inflammation mediated by prostaglandin E2 (PGE2) and nerve growth factor (NGF). Intracanal cryotherapy has been proposed to reduce postoperative pain through local hypothermia-induced vasoconstriction, neuropraxia, and reduced metabolic and inflammatory mediator activity. While prior studies have examined cryotherapy's effect on postoperative pain, no randomized controlled trial has jointly measured PGE2 and NGF using minimally invasive sampling methods (GCF and saliva) in the context of single-visit retreatment.
Eligible patients will be systemically healthy adults (18-65 years, ASA I-II) with a single-rooted mandibular premolar tooth requiring non-surgical retreatment due to a previously inadequate root canal treatment, presenting with asymptomatic apical periodontitis and periapical radiolucency (PAI ≥ 3). Key exclusion criteria include pregnancy or lactation, uncontrolled diabetes mellitus (HbA1c > 7%), autoimmune disease, immunosuppressive therapy, systemic corticosteroid use within the past 3 months, BMI > 35 kg/m², acute infection (abscess/cellulitis), advanced periodontal breakdown, heavy smoking (>10 cigarettes/day), recent analgesic/NSAID or antibiotic use, and chronic pain syndromes.
Patients will be randomly allocated (computer-generated randomization, sealed envelopes) to one of two parallel groups:
Group A (Cryotherapy): Following standard non-surgical retreatment instrumentation, final intracanal irrigation with sterile saline cooled to 2.5°C, 20 mL, over 5 minutes.
Group B (Control): Identical protocol using sterile saline at room temperature (20-22°C), 20 mL, over 5 minutes.
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
Laboratory personnel analyzing saliva and GCF samples (PGE2, NGF via ELISA), as well as the statisticians performing data analysis, will be blinded to group allocation. The treating clinician cannot be blinded due to the nature of the intervention (irrigation temperature).
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
- •Age 18-65 years, systemically healthy individuals (ASA I-II)
- •Single-rooted mandibular premolar teeth with a previous root canal treatment, requiring non-surgical retreatment due to asymptomatic apical periodontitis
- •Presence of periapical radiolucency (Periapical Index [PAI] ≥ 3)
- •No antibiotic use within the past 1 month
- •Willing to participate and has signed the informed consent form
排除标准
- •Pregnancy or lactation
- •Uncontrolled diabetes mellitus (HbA1c > 7%), diagnosed autoimmune disease, or receiving immunosuppressive therapy
- •Systemic corticosteroid use within the past 3 months
- •Body mass index (BMI) greater than 35 kg/m²
- •Presence of acute infection (e.g., acute apical abscess or cellulitis)
- •Conditions precluding retreatment, including advanced periodontal breakdown (clinical attachment loss > 5 mm), root resorption, perforation, or advanced canal calcification
- •Absence of an opposing (antagonist) tooth resulting in lack of functional occlusal contact
- •Diagnosed chronic pain syndrome or currently receiving active psychiatric treatment
- •Smoking more than 10 cigarettes per day
- •Use of analgesics or NSAIDs within the past 24 hours
- •Antibiotic use within the past 1 month
结局指标
主要结局
Postoperative pain intensity (VAS score)
时间窗: Baseline, then at 6, 12, 24, 48, and 72 hours and on Day 7 postoperatively (primary comparison at 24 hours)
Postoperative pain intensity assessed using a Visual Analog Scale (VAS, 0-100 mm, where 0 = no pain and 100 = worst imaginable pain), self-reported by patients. The 24-hour time point is designated as the primary comparison between the cryotherapy and control groups.
次要结局
- Salivary nerve growth factor (NGF) levels(Baseline (T0), 24 hours (T1), and 72 hours (T2) postoperatively)
- Gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) levels(Baseline (T0), 24 hours (T1), and 72 hours (T2) postoperatively)
研究者
Hatice BÜYÜKÖZER ÖZKAN
Associate Professor
Alanya Alaaddin Keykubat University