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临床试验/NCT06276842
NCT06276842已完成1 期

Efficacy of Combining an Inferior Alveolar Nerve Block With a Buccal Infiltration for Mandibular Molars With Irreversible Pulpitis

CIMS Dental College1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone

研究概览

简要总结

OBJECTIVE To compare the effectiveness of using both a combined technique of an Inferior Alveolar Nerve block and buccal infiltration with that achieved by utilizing an Inferior Alveolar Nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis.

STUDY DESIGN Randomized clinical trial PLACE AND DURATION OF STUDY Operative Dentistry Department of Armed Forces Institute of Dentistry Rawalpindi, from 1st April 2020 to 31st September 2020.

MATERIAL AND METHODS A total of 120 patients were enrolled in the study. Sixty patients of group A received conventional Inferior Alveolar Nerve block and sixty patients of Group B received buccal infiltration along with conventional Inferior Alveolar Nerve block.

详细描述

Patients of Group A received Inferior Alveolar Nerve block anesthesia. For this block, nerve was approached from the contra-lateral side of the oral cavity over the contralateral premolars. Needle penetrated into the mandibular tissue on the average boundary of the mandibular ramus inside the pterygomandibular space and lateral to pterygomandibular fold, it advanced until bony surface was contacted. In the event that bony contact wasn't made inside 27-29 mm of needle infiltration, needle was pulled back somewhat, moved the needle further distally toward premolars. The needle was withdrew 1-2 mm after making bony contact, aspiration was performed, followed by 1.8 ml deposition of anesthetic solution.

Patients of Group B received buccal infiltration as supplementary injection technique to conventional Inferior Alveolar Nerve block, buccal infiltration was carried out. The needle was penetrated in buccal mucosa adjacent to mandibular 1st molar. After aspiration, 1.8ml of anesthetic solution was dumped in approximate time of 2 minutes using 2% lignocaine with 1:100,000 epinephrine. Following time period of 15 minutes of injection, every patient was inquired about his/her lip numbness. Patients who did not experience significant lip numbness within 15 minutes after the block was administered were excluded from the investigation and was considered ineffective. In case of positive lip numbness patient concerned teeth was isolated using rubber dam and a traditional access opening was started. Patient was told to lift hand if any pain will occur while doing procedure. The patient was requested to mark pain on visual analogue scale (VAS) after completion of treatment. Absence of pain was indicated if patient scored his/her pain ≤ 3 on VAS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Mandibular molars with irreversible pulpitis (confirmed by positive response to EPT)
  • Patient age between 18 to 45 years
  • No medication taken 24 hours before treatment
  • Both male and female patients

排除标准

  • Patients on analgesics or anti-inflammatory drugs
  • Medically compromised patients
  • Teeth with immature apices
  • Retreatment cases
  • Patients allergic to lignocaine
  • Teeth with root resorption
  • Teeth with necrotic pulp
  • Apical abscess
  • Pregnancy

研究组 & 干预措施

Patient of Group A given Inferior Alveolar Nerve Block

Experimental

The intervention involved approaching the nerve from the contralateral side of the oral cavity over the contralateral premolars. The needle was inserted into the mandibular tissue along the average boundary of the mandibular ramus within the pterygomandibular space and lateral to the pterygomandibular fold. If bony contact was not achieved within 27-29 mm of needle insertion, the needle was slightly withdrawn and repositioned more distally toward the premolars. After achieving bony contact, the needle was withdrawn by 1-2 mm, aspiration was performed, and then 1.8 ml of anesthetic solution was deposited.

干预措施: Inferior Alveolar Nerve Block (Drug)

Group B-buccal infiltration-supplementary injection technique to Inferior Alveolar Nerve block

Experimental

The intervention began by penetrating the needle into the buccal mucosa adjacent to the mandibular first molar. After aspiration, 1.8 ml of anesthetic solution (2% lignocaine with 1:100,000 epinephrine) was administered over approximately 2 minutes. Following a 15-minute period post-injection, each patient was asked about the level of numbness in their lip. Patients who did not experience significant lip numbness within this 15-minute timeframe were excluded from the study. For patients who reported positive lip numbness, the affected tooth was isolated using a rubber dam, and a traditional access opening procedure was initiated.

干预措施: Buccal Infiltration (Drug)

Group B-buccal infiltration-supplementary injection technique to Inferior Alveolar Nerve block

Experimental

The intervention began by penetrating the needle into the buccal mucosa adjacent to the mandibular first molar. After aspiration, 1.8 ml of anesthetic solution (2% lignocaine with 1:100,000 epinephrine) was administered over approximately 2 minutes. Following a 15-minute period post-injection, each patient was asked about the level of numbness in their lip. Patients who did not experience significant lip numbness within this 15-minute timeframe were excluded from the study. For patients who reported positive lip numbness, the affected tooth was isolated using a rubber dam, and a traditional access opening procedure was initiated.

干预措施: Inferior Alveolar Nerve Block and Buccal Infiltration (Combination Product)

结局指标

主要结局

Comparison of Anesthesia Effectiveness Between Combined Technique (Inferior Alveolar Nerve Block and Buccal Infiltration) and Inferior Alveolar Nerve Block Alone

时间窗: 6 months

This investigation aims to assess the effectiveness of a combined technique involving an Inferior Alveolar Nerve block and buccal infiltration in providing supplementary anesthesia for the treatment of symptomatic irreversible pulpitis in the local population. The study will utilize quantitative measures to evaluate the number of participants experiencing successful anesthesia, measured by specific parameters such as pain relief scores. If demonstrated to be more effective than traditional methods, this technique may be recommended for routine clinical practice.

次要结局

未报告次要终点

研究者

发起方
CIMS Dental College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayesha Ahmed

Demonstrator,Operative Dentistry Department

CIMS Dental College

研究点 (1)

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