Clinical trial NCT06272903: Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Effect of Benzocaine on Pain
Lead sponsor: Mohammed Bin Rashid University of Medicine and Health Sciences
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immediate Pain Levels
timeFrame: Immediate (within 30 seconds of placing elastomeric orthodontic separators)
Secondary outcomes:
measure: Patient Satisfaction During Procedure
timeFrame: Immediate (within 30 seconds)
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Mohammed Bin Rashid University Of Medicine and Health Sciences
Study officials:
affiliation: Mohammed Bin Rashid University of Medicine and Health Sciences
name: Simran Kaur Sura
role: PRINCIPAL_INVESTIGATOR
References:
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