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 range4 Years – 10 Years
SexALL
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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.
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