Evaluation of Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Dental Pain
研究概览
简要总结
The aim of this study is to analyze the effectiveness of articaine in controlling self-reported pain compared with conventional lidocaine anesthesia in children requiring extraction of deciduous maxillary molars. Only one extraction will be performed on each child. At least two consultations will be necessary to carry out the present controlled, randomized, and blinded study. All participants will be treated by the same dentist. Self-reported pain will be assessed using the Visual Analogue Scale.
详细描述
In the present study, self-reported pain during extraction of a maxillary primary molar with one buccal infiltration anesthesia with articaine will be compared with the conventional technique (buccal infiltration and palatal supplementation) with lidocaine. The study design will be a blind, controlled, randomized, non-inferiority clinical trial with two parallel groups. The anesthetic will be administered according to the weight of the child, using a table with the amount of anesthetic per weight group and the maximum recommended dose as reference. The hypothesis is that articaine, due to its anesthetic properties, is able to anesthetize as well as lidocaine with only one oral infiltration, without the need for additional anesthesia, which may guarantee better participant comfort, less dental anxiety, and less chair time. The use of the Visual Analogue Scale is important to assess the pain perceived by the children and to ensure the reliability of the responses. Participant comfort will be evaluated at each stage of the proposed treatment, and withdrawal from participation will be guaranteed at any time.
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
- Single (Outcomes Assessor)
盲法说明
The evaluator will not know to which group the child belongs (anesthetic to be used), nor will he or she see the label of the anesthetic. He or she will be in the room during the initial anesthetic infiltration. All children will be considered participants in the control group, to conceal the anesthetic to be used. The evaluator will be asked to leave the room for as long as necessary to prevent learning whether or not the child receives an additional anesthetic.
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical criteria: the presence of coronary destruction precluding restoration or adequate use of absolute isolation for endodontic and restorative procedures; perforation of the pulp chamber floor.
- •Radiographic criteria: deciduous molars with at least one non-resorbed half-length root presenting carious lesions or defective restorations associated with signs or symptoms suggestive of pulp necrosis with endodontic contraindication (periapical or interradicular lesion extending over more than half of the roots or involving the crypt of the permanent successor tooth; the presence of pathologic resorption of more than 1/3 of one or more roots; failure of endodontic treatment with the persistence of periapical or inter-radicular lesion with or without clinical signs and symptoms; internal resorption).
排除标准
- •Participants with acute pain or presence of odontogenic infection associated with systemic signs and symptoms and in cases of urgency;
- •History of bleeding or blood clotting problems or taking medications that alter blood clotting prior to the procedure;
- •Hypersensitivity or history of allergy to the drugs used in the research;
- •History of liver disease;
- •History of sulfite allergy;
- •Report of post-traumatic stress disorders or recurrent hospitalizations, personality or anxiety disorders, diagnosis of phobias or definite uncooperative behavior;
- •Neurological disorders or communication difficulties;
- •Use of analgesic or anti-inflammatory medications up to 5 hours before the procedure;
- •Parents or guardians unable to be available for follow-up and/or respond to information necessary for the survey within 24 hours of the procedure.
研究组 & 干预措施
Lidocaine
Thirty-eight (38) children will receive conventional infiltration anesthesia (buccal infiltration injection followed by complementary injections on the palatal region) with 2% lidocaine and 1:100,000 epinephrine at a dose previously calculated by weight. Two-thirds of the anesthetic will be injected into the buccal area and 1/3 into the palatal area.
Other Names: Control Group
干预措施: Lidocaine (Drug)
Articaine
Thirty-eightt (38) children will receive a single buccal infiltration injection with 4% articaine and 1:100,000 epinephrine at a dose previously calculated by weight.
Other Names: Test Group
干预措施: Articaine (Drug)
结局指标
主要结局
Dental Pain
时间窗: Immediately after the maxillary primary molar extraction
Self-assessment of pain using the Visual Analogue Scale (VAS 0-100mm, higher values represent a worse outcome)
次要结局
未报告次要终点
研究者
Danielle Cristina Alves Rigo
Principal Investigator
Universidade Federal de Santa Catarina