Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Re… (NCT06272903) | Clinical Trial Compass
CompletedEarly Phase 1
Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns
United Arab Emirates32 participantsStarted 2024-04-14
Plain-language summary
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).
Who can participate
Age range
4 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Immediate Pain Levels
Timeframe: Immediate (within 30 seconds of placing elastomeric orthodontic separators)
Trial details
NCT IDNCT06272903
SponsorMohammed Bin Rashid University of Medicine and Health Sciences