An Early Phase 1 interventional study of 20% benzocaine, topical anesthetic and Children's Toothpaste in Effect of Benzocaine on Pain, sponsored by Mohammed Bin Rashid University of Medicine and Health Sciences. Completed at 1 site in United Arab Emirates. Open to participants aged 4 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Mohammed Bin Rashid University of Medicine and Health Sciences · Early Phase 1, Interventional, and Treatment
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).
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.
Mohammed Bin Rashid University of Medicine and Health Sciences is the lead sponsor of 20 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
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.
Drug: 20% benzocaine, topical anesthetic
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.
Other: Children's Toothpaste
Indicated as a topical anesthetic for use on oral mucosa prior to local anesthetic injections, scaling and prophylaxis. Also useful to relieve discomfort associated with taking impressions and intra- oral radiographs. The benzocaine topical anesthetic will be applied according to standard clinical practice, aiming to provide local anesthesia to the treatment site and minimize discomfort during the procedure (placing elastomeric orthodontic separators).
Strawberry-flavored children's toothpaste available in Dubai, UAE.
Immediate Pain Levels
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.
Time frame: Immediate (within 30 seconds of placing elastomeric orthodontic separators)
Patient Satisfaction During Procedure
I will be gathering feedback from the children regarding their overall satisfaction with the procedure by using the Wong-Baker Faces pain scale. This will enable us to gauge the acceptability of placing the elastomeric orthodontic separators.
Time frame: Immediate (within 30 seconds)
Plan to share: No
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Mohammed Bin Rashid University of Medicine and Health Sciences