The Immediate Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Elastomeric Orthodontic Separators in Children Receiving Hall Technique Crowns: a Randomized Control Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Immediate Pain Levels
研究概览
简要总结
The goal of this RCT is to investigate the immediate effect of benzocaine 20% topical anesthesia on initial pain and discomfort levels associated with the placement of elastomeric orthodontic separators in children who are receiving Hall Technique crowns on primary molars, among children who have attended the Pediatric Dentistry Department, Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United Arab Emirates (UAE).
详细描述
The primary objective of this RCT is to assess the immediate effect of benzocaine 20% topical anesthesia on the initial pain and discomfort experienced during the placement of elastomeric orthodontic separators in pediatric patients undergoing Hall Technique crowns for their primary molars. This study will be conducted among children aged 4-10 years old, receiving dental care at the Pediatric Dentistry Department of Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, United Arab Emirates (UAE).
The research will involve recruiting a sample of 32 pediatric patients aged between 4 and 10 years who require 2 Hall Technique crowns on their primary molars and are scheduled to undergo the placement of elastomeric orthodontic separators as part of their treatment. The participants will be randomly assigned to receive benzocaine 20% topical anesthesia prior to separator placement on either the right or left side of their mouth, and the other side receiving a placebo (e.g., children's toothpaste) before separator placement.
Data collection: following the placement of elastomeric orthodontic separators, participants will be asked to rate their pain and discomfort levels immediately after the procedure using the Wong-Baker FACES Pain Rating Scale.
In addition to pain and discomfort assessments, demographic data (e.g., age, gender) and clinical information (e.g., specific teeth undergoing treatment) will be collected for each participant. The study will employ rigorous blinding procedures to ensure that the participants are unaware of the assigned treatment (benzocaine or placebo) during the procedure and data collection phases. The principle investigator will only be aware of which side of the mouth will be receiving benzocaine just before the procedure via a sealed envelope randomisation.
Statistical analyses will be conducted to compare the pain and discomfort levels between the two treatment groups. The findings of this study will contribute valuable insights into the efficacy of benzocaine 20% topical anesthesia in managing pain associated with elastomeric orthodontic separator placement in pediatric dental patients undergoing Hall Technique crown procedures. Ultimately, the results will inform clinical practice and improve the quality of care provided to pediatric patients undergoing dental procedures.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with asymptomatic non pulpally involved carious primary molars who meet the indications of the HT in Dubai Dental Hospital.
- •Children who require same tooth bilateral HT Crowns in either bilateral or diagonal pattern.
- •Healthy male and female children, aged 4-10 years (ASA 1) with no conditions that affect sensory input/reaction.
- •Children who are verbal and able to communicate.
- •Not taking any painkillers, or other drugs that would influence with their pain perception.
- •Cooperative children.
- •Parents or guardians who consent for their children to be enrolled in the trial.
排除标准
- •Children who are indicated for bilateral HT but do not require EOS, due to pre-existing interdental spaces.
- •Children who are indicated for bilateral HT but parents prefer or indicate preference for the Modified HT.
- •Children with allergies to nickel or other metal components that constitute a PMC.
- •Those with reported allergies to topical or local anesthetic.
- •Children with special health care needs or those who are non-verbal and are unable to communicate their pain levels.
- •Children/parents/guardians not willing to participate in the study.
- •Patients that require treatment under conscious sedation or general anesthesia.
研究组 & 干预措施
Benzocaine 20% Topical Anesthesia Arm
Participants will be assigned this arm either to their right or left hand side of their mouth. They will receive benzocaine 20% topical anesthesia prior to the placement of elastomeric orthodontic separators.
The topical anesthesia will be applied according to standard clinical practice. Pain and discomfort levels associated with the placement of separators will be assessed immediately after the procedure.
干预措施: 20% benzocaine, topical anesthetic (Drug)
Placebo (Children's Toothpaste) Arm
The other side of the mouth will receive a placebo, which consists of children's toothpaste, prior to the placement of elastomeric orthodontic separators.
The toothpaste will be applied according to standard clinical practice. Pain and discomfort levels associated with the placement of separators will be assessed immediately after the procedure.
干预措施: Children's Toothpaste (Other)
结局指标
主要结局
Immediate Pain Levels
时间窗: Immediate (within 30 seconds of placing elastomeric orthodontic separators)
The primary outcome measure is the immediate pain and discomfort experienced by children following the placement of EOSs in the context of placing them before the Hall Technique Crown is placed. It will be assessed using a standardized pain scale (Wong-Baker Faces pain scale) where the participants will rate their pain levels immediately after the procedure.
次要结局
- Patient Satisfaction During Procedure(Immediate (within 30 seconds))
研究者
Simran Kaur Sura
Resident - Pediatric Dentistry
Mohammed Bin Rashid University of Medicine and Health Sciences