Topical Intrapocket Anesthesia With Prilocaine and Lidocaine as Alternative to Injectable Anesthesia During Scaling and Root Planing - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 主要终点
- Pain and discomfort
研究概览
简要总结
Injectable anesthesics previous to subgingival scaling and root planing (SRP) presents some disadvantages like fear of the needle insertion, long-lasting effect and prolonged dampening of adjacent tissues. This study will compare the intrapocket anesthetic effectiveness of a skin topical anesthesic EMLA with intrapocket 2% benzocaine, intrapocket placebo and injectable anaesthesia for SRP in a Split-mouth, double-blind, clinical trial study.
详细描述
Objective
The aim of this study was to compare the effect of a eutectic mixture containing 25 mg/g of lidocaine and 25 mg/g of prilocaine (EMLA®) with injectable 2% lidocaine, topical benzocaine, and 2% placebo for reducing pain during subgingival scaling and root planing (SRP) procedures.
Methods: Thirty-two patients were enrolled in this split-mouth, double-blind randomized clinical trial. Patients were randomized to a sequence of four anesthetics: 25 mg/g lidocaine and 25 mg/g of 5% prilocaine (EMLA®), injectable 2% lidocaine, topical 2% benzocaine, or placebo. Pain and discomfort were measured using a Visual Analogue Scale (VAS) and Verbal Scale (VS). Patient satisfaction with anesthesia was also determined at the end of each treatment session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible individuals for the study were selected from those requiring SRP with at least 2 experimental teeth in four of the six sextants.
- •each experimental teeth had to present ≥ 1 site with probing depth ≥ 5 mm associated with BP after treatment of gingivitis (without marginal bleeding).
- •furthermore, individual should present ≥ 18 years-old, have not ever done periodontal treatment and be able to understand Verbal Scale (VS) and Visual Analog Scale (VAS).
- •Exclusion criteria:
- •patients that related allergy history or sensitivity reaction to any used amide or ester anesthetics form,
- •who received anesthesia or sedation 12 hours before SRP,
- •who presented ulcerated lesions or abscesses in the oral cavity,
- •who presented oral pathologies with immediate surgical,
- •who had prior abuse alcohol history, pregnant women,
- •who presented uncontrolled hypertension or
- •who had participated in a clinical trial of investigational drug before four months from the beginning of this study.
排除标准
- 未提供
研究组 & 干预措施
sextant 1
Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (EMLA)
干预措施: EMLA (Drug)
sextant 2
Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Injectable anesthesia)
干预措施: Injectable anesthesia (Drug)
sextant 3
Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (2% Benzocaine)
干预措施: 2% Benzocaine (Drug)
sextant 4
Treatment with subgingival scaling and root planing was done in 6 weekly sessions, being the sextant 1 in the randomization for experimental procedures (Placebo)
干预措施: Placebo (Drug)
结局指标
主要结局
Pain and discomfort
时间窗: For each tooth was evaluated intraoperative pain using the Visual Analog Scale (5 minutes after the start of the instrumentation) and postoperative immediately after instrumentation. At the end of the procedure, was asked Verbal Scale, for 4 weeks.
For each experimental tooth, the patient was asked to indicate the intensity of pain and discomfort experienced intraoperatively using the VAS (VAStrans) (5 minutes after the start of the instrumentation in each tooth) and postoperatively (VASpost) immediately after the end of instrumentation of the respective tooth. At the end of the procedure, the patient was asked to also describe the pain sensation of the tooth using VS as: no pain (0), mild pain (1), moderate pain (2), severe pain (3), or extremely severe pain (4).
次要结局
- Patient satisfaction with anesthesia(Determined at the end of all treatment sessions, for 4 weeks.)
- Injectable anesthetic requirement(If pain persisted after this second application, then an anesthesia infiltration/block was performed, for 4 weeks.)
- Adverse Events(Determined when each patient returned for the next treatment session, for 4 weeks.)
研究者
Raquel Pippi Antoniazzi
Topical intrapocket anesthesia with prilocaine and lidocaine as an alternative to injectable anesthesia during scaling and root planing - A randomized clinical trial
Franciscan University Center