Comparative clinical efficacy of 4 percent articaine infiltration versus 2 percent lignocaine IANB block for anesthiesia of DMH-affected primary second molar - Split mouth Randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Anesthetic Success Rate
研究概览
简要总结
This split-mouth randomized controlled trial aims to compare the clinical efficacy of 4% articaine administered by buccal infiltration with 2% lignocaine administered through inferior alveolar nerve block (IANB) for achieving local anesthesia in DMH-affected primary second molars in children. Each participant will receive both anesthetic techniques on contralateral sides during separate appointments. The primary outcome will be the success of anesthesia as assessed by pain experienced during dental treatment. Secondary outcomes will include onset and duration of anesthesia, pain during injection, need for supplemental anesthesia, child behavior, and the occurrence of any adverse events. The findings of this study will help determine the most effective and child-friendly anesthetic technique for managing dental procedures in DMH-affected primary molars.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 4 to 8 years requiring dental treatment for bilateral DMH-affected primary second molars in the mandible.
- •Children diagnosed with dentin hypersensitivity/dentin mineralization hypoplasia (DMH) involving primary second molars, confirmed clinically and radiographically.
- •Teeth indicated for restorative treatment or pulpal therapy requiring local anesthesia.
- •Children classified as ASA Physical Status I or II.
- •Children exhibiting positive or definitely positive behavior (Frankl Behavior Rating Scale).
- •Availability of bilaterally comparable teeth, allowing a split-mouth study design.
- •Children whose parents or legal guardians provide written informed consent, with assent obtained from the child where appropriate.
排除标准
- •Exclusion Criteria Children with a known allergy or hypersensitivity to articaine, lignocaine, or amide local anesthetics.
- •Children with systemic diseases, bleeding disorders, or neurological conditions that contraindicate local anesthesia administration.
- •Children with acute dental infection, abscess, cellulitis, or swelling in the region of the involved teeth.
- •Teeth with advanced pathological root resorption, periapical pathology, or mobility exceeding physiological limits.
- •Children with negative behavior (Frankl Rating I or II) that could compromise the administration or assessment of local anesthesia.
- •Children with a history of failed mandibular nerve block or anatomical abnormalities affecting nerve block efficacy.
- •Children with special healthcare needs that could interfere with pain perception, communication, or cooperation during treatment.
结局指标
主要结局
Anesthetic Success Rate
时间窗: 0 days
Assessed by the absence of pain during the dental procedure on the DMH-affected primary second molar following administration of the assigned anesthetic technique (4% articaine infiltration or 2% lignocaine inferior alveolar nerve block).
时间窗: 0 days
Pain will be evaluated using an age-appropriate validated pain scale (e.g., Wong–Baker FACES Pain Rating Scale) at the time of operative intervention.
时间窗: 0 days
次要结局
未报告次要终点
研究者
Rasika Chandak
Saveetha Dental College and Hospital.