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
| Registry | NCT06272903 |
|---|---|
| Status | Completed |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 32 (Actual) |
| Sponsor | Mohammed Bin Rashid University of Medicine and Health Sciences (Other) |
| Conditions | Effect of Benzocaine on Pain |
| Interventions | 20% benzocaine, topical anesthetic, Children's Toothpaste (Drug, other) |
| Dates | start 2024-04-14, primary completion 2024-12-16, completion 2024-12-16, first posted 2024-02-22, last updated 2025-03-19 |
| Locations | 1 site in United Arab Emirates |
Related Papers Related Patents Related Grants Related Experts
All trials for Effect of Benzocaine on Pain All trials of 20% benzocaine, topical anesthetic All trials of Children's Toothpaste
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Benzocaine 20% Topical Anesthesia Arm | Experimental | Drug: 20% benzocaine, topical anesthetic | 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. |
| Placebo (Children's Toothpaste) Arm | Placebo comparator | Other: Children's Toothpaste | 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. |
Sex: All, ages: 4 Years to 10 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Mohammed Bin Rashid University Of Medicine and Health Sciences | Dubai | United Arab Emirates |