Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns

NCT06272903 | Completed Early Phase 1

• 1 other identifier: MBRU IRB-2023-228
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Effect of Benzocaine on Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediate (within 30 seconds of placing elastomeric orthodontic separators)

Secondary Outcomes (1)

• Patient Satisfaction During Procedure

  Immediate (within 30 seconds)

Study Arms (2)

Benzocaine 20% Topical Anesthesia Arm

EXPERIMENTAL

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

Placebo (Children's Toothpaste) Arm

PLACEBO COMPARATOR

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

Interventions

20% benzocaine, topical anesthetic DRUG

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).

Benzocaine 20% Topical Anesthesia Arm

Children's Toothpaste OTHER

Strawberry-flavored children's toothpaste available in Dubai, UAE.

Placebo (Children's Toothpaste) Arm

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohammed Bin Rashid University of Medicine and Health Sciences: lead

Study Sites (1)

Mohammed Bin Rashid University Of Medicine and Health Sciences

Dubai, United Arab Emirates

Location

Related Publications (12)

• Hussein I, Al Halabi M, Kowash M, Salami A, Ouatik N, Yang YM, Duggal M, Chandwani N, Nazzal H, Albadri S, Roberts A, Al-Jundi S, Nzomiwu C, El Shahawy O, Attaie A, Mohammed O, Al-Sane M. Use of the Hall technique by specialist paediatric dentists: a global perspective. Br Dent J. 2020 Jan;228(1):33-38. doi: 10.1038/s41415-019-1100-2.

  PMID: 31925371 BACKGROUND

• Boyd DH, Foster Page LA, Moffat SM, Thomson WM. Time to complain about pain: Children's self-reported procedural pain in a randomised control trial of Hall and conventional stainless steel crown techniques. Int J Paediatr Dent. 2023 Jul;33(4):382-393. doi: 10.1111/ipd.13059. Epub 2023 Mar 16.

  PMID: 36841968 BACKGROUND

• Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.

  PMID: 28879311 BACKGROUND

• Aghababaie ST, Monteiro J, Stratigaki E, Ashley PF. Techniques for effective local anaesthetic administration for the paediatric patient. Br Dent J. 2020 Dec;229(12):779-785. doi: 10.1038/s41415-020-2453-2. Epub 2020 Dec 18.

  PMID: 33339924 BACKGROUND

• Bird SE, Williams K, Kula K. Preoperative acetaminophen vs ibuprofen for control of pain after orthodontic separator placement. Am J Orthod Dentofacial Orthop. 2007 Oct;132(4):504-10. doi: 10.1016/j.ajodo.2006.11.019.

  PMID: 17920504 BACKGROUND

• Farzan A, Khaleghi K. The Effectiveness of Low-Level Laser Therapy in Pain Induced by Orthodontic Separator Placement: A Systematic Review. J Lasers Med Sci. 2021 Jun 24;12:e29. doi: 10.34172/jlms.2021.29. eCollection 2021.

  PMID: 34733752 BACKGROUND

• Al-Melh MA, Nada A, Badr H, Andersson L. Effect of an Anesthetic Chewing Gum on the Initial Pain or Discomfort from Orthodontic Elastomeric Separator Placement. J Contemp Dent Pract. 2019 Nov 1;20(11):1286-1292.

  PMID: 31892680 BACKGROUND

• Eslamian L, Borzabadi-Farahani A, Edini HZ, Badiee MR, Lynch E, Mortazavi A. The analgesic effect of benzocaine mucoadhesive patches on orthodontic pain caused by elastomeric separators, a preliminary study. Acta Odontol Scand. 2013 Sep;71(5):1168-73. doi: 10.3109/00016357.2012.757358. Epub 2013 Jan 10.

  PMID: 23301559 BACKGROUND

• Meechan JG. Intraoral topical anesthesia. Periodontol 2000. 2008;46:56-79. doi: 10.1111/j.1600-0757.2008.00231.x. No abstract available.

  PMID: 18201346 BACKGROUND

• Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press J Orthod. 2015 May-Jun;20(3):13-5. doi: 10.1590/2176-9451.20.3.013-015.ebo. No abstract available.

  PMID: 26154451 BACKGROUND

• Garrocho-Rangel A, Ruiz-Rodriguez S, Gaitan-Fonseca C, Pozos-Guillen A. Randomized Clinical Trials in Pediatric Dentistry: Application of Evidence-Based Dentistry through the CONSORT Statement. J Clin Pediatr Dent. 2019;43(4):219-230. doi: 10.17796/1053-4625-43.4.1. Epub 2019 May 16.

  PMID: 31094627 BACKGROUND

• Eslamian L, Kianipour A, Mortazavi SAR. The Analgesic Efficacy of 5% Naproxen Gel for Pain Associated with Orthodontic Separator Placement: A Randomized Double-Blind Controlled Trial. Anesth Pain Med. 2017 Mar 8;7(2):e42708. doi: 10.5812/aapm.42708. eCollection 2017 Apr.

  PMID: 28824857 BACKGROUND

MeSH Terms

Interventions

Benzocaine; Anesthetics, Local

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Simran Kaur Sura

  Mohammed Bin Rashid University of Medicine and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident - Pediatric Dentistry

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: April 14, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)