Efficacy of Articaine Infiltration in Anesthetizing Mandibular Second Primary Molars During Pulpotomy Procedure (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- change in heart rate
研究概览
简要总结
Background: Articaine hydrochloride has steadily grown in popularity, and studies have shown that articaine hydrochloride performs better than lidocaine due to an enhanced anes-thetic efficacy. The most common technique to anesthetize mandibular primary teeth is in-ferior alveolar nerve block (IANB) which induces a relatively sustained anesthesia and in turn may potentially traumatize soft-tissues. Therefore, the need of having an alternative technique of anesthesia with a shorter term but the same efficacy is reasonable.
Aim: Evaluating The effectiveness of Articaine infiltration versus conventional inferior al-veolar nerve block in anesthetizing the second primary mandibular molars during pulpoto-my procedure.
Materials and Methods: The study will be two-arm randomized controlled clinical trial, parallel design and it will be setup and reported according the CONSORT guidelines. A total of 52 healthy children aged 5-6 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 according to Frankl behavioral rating scale. Each child selected will have at least one mandibular second primary molar that is indicat-ed for pulpotomy. Written informed consent will be obtained from guardian. Participants will be randomly and equally allocated to one of the two arms into two groups according to the technique of anesthesia that will be used.
Group I (Experimental group n =26) assigned to articaine infiltration anesthesia, while group II (Control group n = 26) assigned to the conventional IANB injection articaine.
Pain will be assessed by three diferent methods: physiological method using the Heart rate as vital parameter of pain, and will be recorded at base line, during injection, pulpotomy and stainless steel crown (SSC) preparation. Objective method using Sensory, Eye, Motor (SEM) scale, and subjective method where the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive or definitely positive behavior during preoperative assessments according to the Frankl's behavior ratings III and IV.
- •Patients whose mandibular second primary molars are indicated for pulpotomy according to the AAPD.
- •Patients whose parents will give their consent to participate
排除标准
- •Children with any systemic disease or special health care.
- •History of allergy to local anesthesia.
- •Radiographic evidence of periapical or inter-radicular radiolucency
- •Patients with previous negative dental experience.
- •Presence of soft tissue lesions at the site of injection.
结局指标
主要结局
change in heart rate
时间窗: During procedure
Heart rate (HR) is a physiological sign of pain.(30) It will be measured using a pulse oximeter.
change in pain level
时间窗: During procedure
Sound, Eye, Motor (SEM) Scale(31) (Appendix III), will used as an ob-jective method for pain assessment during LA administration, pulpo-tomy and SSC. It comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial ob-server using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: com-fort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by sum-ming the three grades of the parameters.
次要结局
- Adevrse events(After 24 hours)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University