跳至主要内容
临床试验/NCT06333730
NCT06333730Unknown不适用

Comparison of Anesthetic Efficacy of Mental Nerve Block Versus Inferior Alveolar Nerve Block in Mandibular Anterior Teeth and Premolars in Symptomatic Irreversible Pulpitis- A Randomized Clinical Trial

Prime Foundation2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
96
试验地点
2
主要终点
COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS

研究概览

简要总结

Symptomatic irreversible pulpitis is a painful condition that requires anesthesia to perform effective dental procedures. The mental nerve block and inferior alveolar nerve block are two commonly used techniques for achieving anesthesia in the mandibular teeth.

Study design: This randomized clinical trial study Number of participants: 96 participants which will be randomly divided into two groups: MINB and IANB.

Inclusion criteria: Participants with mandibular premolars or lower anterior experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening, will be included.

Exclusion criteria: Participants with a medical history, allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those taking pain-affecting medication, or those experiencing pain in more than one tooth will be excluded.

Both techniques will use 2% lidocaine and adrenaline 1:80,000. Age, gender, and the efficacy of anesthesia will be recorded in both groups. The chi-square test will be used for comparison.

详细描述

Symptomatic irreversible pulpitis is a dental condition characterized by inflammation of the dental pulp, a soft tissue containing nerves and blood vessels located within the tooth's central cavity. The inflammation is severe and incapacitates the pulp's ability to heal naturally, leading to its eventual necrosis, hence the label "irreversible." The clinical manifestation of symptomatic irreversible pulpitis is excruciating, unrelenting pain, aggravated by exposure to hot or cold stimuli, and pressure. Inadequate intervention exposes the patient to the risk of infection or abscess formation, necessitating extensive dental procedures, including root canal therapy or tooth extraction.

The inferior alveolar nerve block (IANB) is a widely employed regional anesthesia technique in dentistry, utilized to provide profound anesthesia of the mandibular teeth and gingivae. It is a safe and reliable anesthesia technique commonly used in dentistry to prevent pain during procedures such as extractions, root canals, and implant placement, ensuring a comfortable experience for the patient. The mental or incisive nerve block is a dental anesthesia technique that anesthetizes the lower teeth, gums, lower lip, and chin by blocking the incisive and mental nerves, which are branches of the inferior alveolar nerve.

Local anesthesia in endodontics provides pain relief and patient comfort during procedures such as root canal therapy by blocking nerve impulses that transmit pain signals to the brain. Painful pulpitis may require pulpectomy under local anesthesia, but the effectiveness of injections can vary between teeth, with mandibular teeth being less responsive compared to maxillary teeth due to their thicker cortical bone and more complex anatomy. The inferior alveolar nerve is typically blocked in the lower molar and premolar region to achieve numbness. However, this approach may not always provide complete numbing of the nerve endings in the teeth. To enhance the likelihood of success, it is recommended to administer supplemental injections such as intra-osseous injections or applying 4% articaine through the cheek along with the inferior alveolar nerve block.

In a randomized clinical trial with 153 participants, the anesthetic success rates for mental nerve block and IANB were 53% and 47%, respectively, with no significant difference between them. However, combining both techniques by adding an IANB to MINB significantly improved the success rates to 82%. In a study conducted by Batista da Silva and colleagues, the effectiveness of 0.6 mL of 2% lidocaine and 4% articaine administered outside the mental foramen was evaluated. The results showed that using 4% articaine resulted in a 70% to 80% success rate for anesthesia.

This randomized clinical trial will be conducted at department of operative dentistry, Peshawar dental college, Peshawar. Ethical approval will be obtained from the hospital's ethical board. The sample size will be 96(48 in each group) at 5% level of significance, 80% power of test, using success for IANB to be 53% and to be mental block 80%. To participate in this study, patients needed to have exposed caries in their mandibular premolars or lower anterior causing sharp and persistent pain in response to thermal stimuli and an electric pulp tester, as well as bleeding during access opening. They also needed to have a medical history falling under American Society of Anesthesiologists class I or II and understand pain scales. Patients with allergies or contraindications to the local anesthetic, pregnant or breastfeeding women, those with a history of drug abuse, taking pain-affecting medication, or experiencing active pain in more than one tooth will be excluded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Participants with mandibular premolars or lower anterior
  • Experiencing sharp and persistent pain in response to thermal stimuli and an electric pulp tester
  • Bleeding during access opening

排除标准

  • Participants with a medical history
  • Allergies or contraindications to the local anesthetic
  • Pregnant or breastfeeding women
  • Patient taking pain-affecting medication
  • Patient experiencing pain in more than one tooth

结局指标

主要结局

COMPARISON OF ANESTHETIC EFFICACY OF MENTAL NERVE BLOCK VERSUS INFERIOR ALVEOLAR NERVE BLOCK IN MANDIBULAR ANTERIORS TEETH AND PREMOLARS IN SYMPTOMATIC IRREVERSIBLE PULPITIS

时间窗: Two months

Pain after anesthesia in both groups will be assessed through Visual Pain analogue scale and greater than 3 will be considered ineffective

次要结局

未报告次要终点

研究者

发起方
Prime Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Iftikhar Akbar

Head of Operative dentistry & Endodontic, Professor, Principal investigator

Prime Foundation

研究点 (2)

Loading locations...

相似试验

Comparison of Anesthetic Efficacy of Mental Nerve... | 临床试验