Effect Of Cryotherapy On Anesthetıc Success And Intraoperatıve Paın In Mandıbular Premolars Wıth Irreversıble Pulpıtıs: A Prospectıve Randomızed Clınıcal Trıal
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Intraoperative pain
研究概览
简要总结
This prospective randomized clinical trial aimed to evaluate the effects of different anesthesia protocols on anesthetic success and intraoperative pain during root canal treatment of mandibular premolars diagnosed with symptomatic irreversible pulpitis. A total of 100 systemically healthy patients were randomly allocated into four groups: infiltration anesthesia alone, inferior alveolar nerve block (IANB) alone, infiltration anesthesia combined with cryotherapy, and IANB combined with cryotherapy. Cryotherapy was applied intraorally for 5 minutes immediately after anesthetic administration.
The effectiveness of anesthesia was confirmed using electric pulp testing and cold testing prior to treatment. Root canal therapy was completed in a single visit by a calibrated operator. Intraoperative pain was assessed during access cavity preparation using a visual analogue scale (VAS). Anesthetic success was defined as the presence of no or mild pain, whereas moderate or severe pain indicated anesthetic failure and required supplemental anesthesia.
The primary objective of the study was to determine whether the adjunctive use of cryotherapy improves anesthetic success and reduces intraoperative pain in mandibular premolars with symptomatic irreversible pulpitis. The null hypothesis was that no significant differences would be observed among the study groups in terms of anesthetic success or intraoperative pain intensity.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients classified as ASA I or II, aged between 18 and 60 years,
- •Presence of a restorable mandibular premolar tooth diagnosed with symptomatic irreversible pulpitis,
- •History of spontaneous pain or lingering pain elicited by thermal stimuli,
- •Positive response with lingering pain to cold testing (Endo Ice; Coltene, Altstätten, Switzerland),
- •Positive response at low current levels to electric pulp testing (Parkell Inc., USA),
- •Teeth with closed apex and no radiographic evidence of periapical pathology (intact periodontal ligament space and absence of periapical radiolucency),
- •Patients presenting with moderate or severe preoperative pain, as assessed using the visual analogue scale (VAS).
排除标准
- •Patients who had taken analgesic, anti-inflammatory, or opioid medication within the last 12 hours before treatment,
- •Patients with systemic conditions that may affect pain perception, inflammatory response, or healing,
- •History of antibiotic use within the previous month or requirement for antibiotic prophylaxis,
- •Teeth presenting with clinical or radiographic signs of pulp necrosis or apical periodontitis (Pain on percussion or palpation, presence of sinus tract or swelling, presence of periapical radiolucency),
- •Teeth with root resorption, immature apices, severe coronal destruction preventing proper isolation, or calcified canals,
- •Teeth that had undergone previous endodontic treatment, including pulpotomy or root canal filling,
- •Patients with neurological or psychiatric conditions that could interfere with pain perception or accurate pain reporting,
- •Inability to achieve adequate isolation with a rubberdam.
研究组 & 干预措施
infiltration anesthesia
干预措施: infiltration anesthesia alone (Procedure)
infiltration anesthesia
干预措施: infiltration anesthesia combined with cryotherapy (Procedure)
mandibular anesthesia
干预措施: mandibular anesthesia alone (Procedure)
mandibular anesthesia
干预措施: mandibular anesthesia combined with cryotherapy (Procedure)
结局指标
主要结局
Intraoperative pain
时间窗: Baseline/During the Operation
Intraoperative pain intensity assessed using a Visual Analogue Scale (VAS) (1-10) during access cavity preparation.
次要结局
未报告次要终点
研究者
Ayşe Tuğba Eminsoy Avcı
Lecturer
TC Erciyes University
