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临床试验/CTRI/2026/02/103066
CTRI/2026/02/103066尚未招募2/3 期

Comparative Evaluation Of Efficacy Of Intraligamentary Injection Using Articaine, Ketorolac And Dexamethasone For Reduction Of Endodontic Pain In Symptomatic Irreversible Pulpitis: A Randomized Double Blinded Clinical Study

SAMALA ANUHYA1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年2月19日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
106
试验地点
1
主要终点
The aim of this randomized double-blinded clinical study was to evaluate and compare the efficacy of intra-ligamentary injection using articaine, ketorolac and dexamethasone for reduction of endodontic pain in patients with symptomatic irreversible pulpitis in permanent mandibular molars.

研究概览

简要总结

A total of 81 patients experiencing endodontic pain and requiring root canal treatment were enrolled after informed consent. Following baseline VAS assessment, all patients received a standard Inferior Alveolar Nerve Block using 2 percent Lignocaine with Adrenaline. Those who experienced pain during access cavity initiation were included. Participants were randomised via sealed envelopes into three groups to receive an intraligamentary injection of either articaine, dexamethasone, or ketorolac. The double-blind technique was employed, and injections were administered with back-pressure at the mesiobuccal and distobuccal line angles. Post-injection VAS scores were recorded upon pulpal chamber access. In cases of persistent pain, intrapulpal lignocaine was used. Standardised endodontic procedures followed, including rubber dam isolation, working length determination, rotary instrumentation, irrigation with EDTA and sodium hypochlorite, and obturation with gutta-percha and zinc oxide eugenol sealer using cold lateral compaction. Composite restoration completed the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Healthy individuals with no systemic diseases.
  • Mandibular molars diagnosed as hot tooth with symptomatic irreversible pulpitis.
  • A positive and prolonged response to cold tests and electric pulp tests.

排除标准

  • Patients with a history of known or suspected drug abuse, and patients taking any drugs that could have affected the pain perception.
  • Patients having active pain in more than one tooth were excluded from the study.
  • Teeth with fused roots, radiographic evidence of an extra root, large restorations with overhanging margins, full crowns.
  • Teeth with periodontal diseases and large peri-apical lesions.

结局指标

主要结局

The aim of this randomized double-blinded clinical study was to evaluate and compare the efficacy of intra-ligamentary injection using articaine, ketorolac and dexamethasone for reduction of endodontic pain in patients with symptomatic irreversible pulpitis in permanent mandibular molars.

时间窗: Outcome for pain reduction will be assessed 5 mins after intervention with the drugs and heart rate will be monitored every minute upto 5 minutes after intervention with the drugs as intraligamenntary injection.

次要结局

  • To evaluate heart rate using finger pulse oximeter.(At 15-second intervals until 5 minutes after intra-ligamentary injections. The timer for heart rate measurement started after the end of the distal injections.)

研究者

发起方
SAMALA ANUHYA
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR SAMALA ANUHYA

KAMINENI INSTITUTE OF DENTAL SCIENCES

研究点 (1)

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