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临床试验/CTRI/2024/12/078326
CTRI/2024/12/078326尚未招募2 期

Comparative Evaluation of Pain Perception while Administering Intrapulpal Injection in Mandibular Molars with Symptomatic Irreversible Pulpitis with Three Different Techniques: A Randomized Controlled Trial

SGT UNIVERSITY1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
To compare and evaluate the efficacy of intrapulpal injection with endo-ice and ice stick, intrapulpal injection with benzocaine gel and intrapulpal injection alone in reducing pain perception during administration of intrapulpal injections for symptomatic irreversible pulpitis in mandibular molars.

研究概览

简要总结

AIM:

To compare the pain perception in mandibular molars with Symptomatic Irreversible Pulpitis with three techniques viz Intrapulpal Injection with Endo Ice and Ice Sticks, Intrapulpal Injection with Benzocaine Gel and Intrapulpal Injection alone: A Randomized Controlled Trial

OBJECTIVE:

  1. To compare and evaluate the efficacy of intrapulpal injection with Endo Ice and Ice Stick, intrapulpal injection with Benzocaine Gel and intrapulpal injection alone in reducing pain perception during administration of intrapulpal injections for symptomatic irreversible pulpitis in mandibular molars.

2.    2) To evaluate the extent of pain relief achieved with each intrapulpal anesthetic technique.

METHODOLOGY:30 patients with a non-contributory medical history, will be selected and divided Â·         into three groups.

**GROUP 1 (**n = 10)- Endo Ice and Ice stick application followed by Intrapulpal Injection

**GROUP 2 (**n = 10)- Benzocaine Gel application followed by Intrapulpal Injection

**GROUP 3 (**n = 10)- Intrapulpal Injection alone

Patients diagnosed with symptomatic irreversible pulpitis will receive standard IANB injections by using 1.8ml of 2% lidocaine with 1:80,000 epinephrine for the root canal treatment. The anaesthetic solutionwill be administered with a 27-G, long (31-mm) needle inserted slightly laterally at the middle portion of the pterygomandibular raphe to contact bone with the needle bevel directed toward the bone, slightly withdrawn, and aspirated, and solution will be deposited over a period of 60 seconds.

 After 15 minutes of IANB, each patient will be asked whether his or her ipsilateral lip and tongue are numb. If profound lip numbness is not recorded within 15 minutes, the block will be considered unsuccessful, and the patient will be excluded from the study. When the ipsilateral lip and tongue numbness appear, the involved teeth will be isolated with a rubber dam, and a conventional access opening will be initiated.

 Access opening will be done into the pulpal chamber using high- and low-speed instrumentation with light and intermittent pressure to minimize the patient’s discomfort.

 In case of pain during access opening procedures, patient’s tooth will be classified under Endodontic Emergencies During Treatment as “HOT TOOTH” and the treatment procedure will be stopped. The patient will then be allocated to 1 of the 3 study groups using randomization method mentioned.

 For GROUP 1, Endo-ice (1,1,1,2 tetrafluoroethane) will be applied for a total of 20 seconds (10 seconds on buccal and 10 seconds on lingual surface) of the affected tooth. Subsequently Ice Sticks will be placed directly in pulp chamber for 5 minutes and followed immediately by intrapulpal LA injection. Thereafter patient will be asked to rate the pain during the intrapulpal injection on HP VAS.

 For GROUP 2, after deroofing the pulp chamber, anaesthetic gel (20% Benzocaine) will be applied on exposed pulp for 5 minutes followed by intrapulpal injection. Thereafter patient will be asked to rate the pain during the intrapulpal injection on HP VAS.

For GROUP 3, patient will be given intrapulpal injection alone. Thereafter patient will be asked to rate the pain during the intrapulpal injection on HP VAS.

 Anesthesia will be categorized as determined to be effective when the patient could tolerate continuation of the treatment.

 The working length will be confirmed using an electronic apex locator and periapical radiographs. A glide path will be established with K-files up to a size #15, and the canals will be prepared using nickel titanium rotary files. Biomechanical preparation will be done and the root canal procedure will be carried out.

RESULTS: On going research

CONCLUSION: On going research

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Mature permanent mandibular molars diagnosed with symptomatic irreversible pulpitis.
  • Patients who need supplemental anaesthesia (Patient with Endodontic Emergency During Treatment: HOT TOOTH).

排除标准

  • Immunocompromised patients, pregnant and lactating females 2)Periodontally compromised teeth 3)In patient where tooth is un-restorable, inadequate length.
  • Patient with pulp necrosis, periapical radiolucency, sinus tract, periapical abscess.
  • Patients who had taken analgesics within 12 hours before root canal therapy 6)Patients with communication barriers hindering their understanding of the study procedures and requirements.

结局指标

主要结局

To compare and evaluate the efficacy of intrapulpal injection with endo-ice and ice stick, intrapulpal injection with benzocaine gel and intrapulpal injection alone in reducing pain perception during administration of intrapulpal injections for symptomatic irreversible pulpitis in mandibular molars.

时间窗: During administration of intrapulpal injection

次要结局

  • To evaluate the extent of pain relief achieved with each intrapulpal anesthetic technique.(Immediately after injection,)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SHIVANSH AGGROHIYA

SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE GURUGRAM, HARYANA 122505

研究点 (1)

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