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临床试验/NCT05122819
NCT05122819招募中不适用

Evaluation of Efficacy of Intraligamentary Anesthesia by Two Different Techniques for Extraction of Mandibular Molars: A Randomized Controlled Trial

Hamdard University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Pain on injection

研究概览

简要总结

Dental extraction is the most common procedure undertaken in the department of Oral Surgery, inferior alveolar nerve block (IANB), till today, is the most commonly used local anaesthesia technique for extraction of lower posterior teeth. The anatomical complexity of this technique carries the risk of anaesthetic failures necessitating repeated needle penetrations and hence a painful experience for the patient. In addition, IANB technique, many times, becomes impossible to perform in fearful adult and paediatric patients, those with restricted mouth opening or intellectual disability. Certain coagulation defects are a contraindication to administration of IANB due to its depth of penetration into the tissues that may lead to fatal consequences in case of uncontrolled bleeding. Because of these shortcomings of IANB, there is always a need for alternative anaesthesia techniques that are less painful and carry lesser risks.

Anaesthetic injection into the Periodontal ligament space (space between tooth root surface and the bone forming the socket wall) as an alternative to IANB have been tested by many researchers with varying results. The expected advantages of this technique are reduced pain on injection, shorter duration of anaesthesia that prevents inadvertent lips and cheek biting after completion of the procedure. It is expected to be easier to perform in cases of restricted mouth opening and uncooperative patients due to any reason and carry lesser risk of bleeding within tissues.

The objective of our study is to evaluate the efficacy of Intra-ligamentary injection for posterior mandibular molar extraction as an alternative to inferior alveolar nerve block (IANB) so that it can be used in cases where IANB is either difficult to perform or not indicated.

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
None

入排标准

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

入选标准

  • Age 18 years and above
  • Both genders.
  • Teeth selection: Mandibular first and second molars needing extraction under local anaesthesia.
  • Healthy patients or those with well controlled systemic disease.
  • Patients consenting to participate in the study.
  • Exclusion criteria:
  • Patients younger than 18 years.
  • Mandibular third molars, acutely inflamed or infected first and second molars.
  • Pregnant patients and those with poorly controlled systemic disease.
  • Mentally handicapped patients.
  • Patients not consenting to participate in the study.

排除标准

  • 未提供

结局指标

主要结局

Pain on injection

时间窗: Immediately after local anesthesia administration regardless of the technique.

Pain on injection will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.

Local anesthesia success

时间窗: 1 minute after local anesthesia administration by intraligamentary injection regardless of the syringe used. 6 minutes after administration of Inferior Alveolar Nerve Block (IANB).

Local anesthesia success will be checked by using Numeric Pain Rating Scale (NPRS). NPRS is an 11 point scale in which 0: no pain, 1-3: mild pain, 4-7: moderate pain, 8-10: worst possible pain.

次要结局

  • Successful completion of Extraction(45 minutes from the first administration of local anesthesia injection.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayesha Basit

Associate Professor

Hamdard University

研究点 (1)

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