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临床试验/CTRI/2025/02/081335
CTRI/2025/02/081335已完成2 期

Comparison of 4% Articaine Buccal Infiltration and 2% Lignocaine Inferior Alveolar Nerve Block for Invasive Dental Procedures in Primary Mandibular Molars along with Assessment of Parental Satisfaction: An Equivalence Parallel Prospective Randomized Controlled Trial

Dr Shreya Pandey1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2025年3月7日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
134
试验地点
1
主要终点
To improve patient co-operation and make dental procedure less traumatic by using articaine buccal infiltration instead of IANB with lignocaine

研究概览

简要总结

This study compares two local anesthesia techniques—2% lignocaine inferior alveolar nerve block (IANB) and 4% articaine buccal infiltration (BI)—for pediatric dental procedures, specifically pulp therapy and extractions of primary mandibular molars. The key points are:

  1. Purpose: Evaluate the effectiveness of both techniques in pain control, children’s reactions to pain, and parental satisfaction.
  2. Relevance: Effective, less stressful anesthesia techniques are essential for pediatric patients, especially given their heightened pain sensitivity and need for behavior management.
  3. Novelty: The study addresses the limited research on articaine in children, particularly its potential to replace IANB for primary mandibular molars.
  4. Applicability: If articaine proves effective, it could shift pediatric dental practices by reducing discomfort and complications associated with IANB.
  5. Outcome: Articaine infiltration may provide effective pain control with less stress, improving patient cooperation and parent satisfaction.

Validated pain scales (MBPS and WBFS) and a parental satisfaction scale (PSLAS) will assess pain and satisfaction levels, helping determine whether articaine is a viable alternative to IANB.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • patients medically healthy patients requiring invasive dental procedure patients showing understanding of pain scale co-operative patients primary molars requiring pulp therapy and extraction.

排除标准

  • medically compromised known allergy to local anesthesia uncooperative patients tooth other than primary molars children younger than 5 and older than 10 years of age.

结局指标

主要结局

To improve patient co-operation and make dental procedure less traumatic by using articaine buccal infiltration instead of IANB with lignocaine

时间窗: Baseline

次要结局

未报告次要终点

研究者

发起方
Dr Shreya Pandey
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Shreya Pandey

Sardar Patel Post Graduate Institute of Dental and Medical Science

研究点 (1)

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