Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-26 @ 9:47 PM
Study NCT ID:
NCT06272903
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001566', 'term': 'Benzocaine'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}], 'ancestors': [{'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate Pain Levels', 'timeFrame': 'Immediate (within 30 seconds of placing elastomeric orthodontic separators)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction During Procedure', 'timeFrame': 'Immediate (within 30 seconds)', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Benzocaine on Pain']}, 'referencesModule': {'availIpds': [{'id': 'MBRU IRB-2023-228', 'url': 'http://www.mbru.ac.ae', 'type': 'Study Protocol'}], 'references': [{'pmid': '31925371', 'type': 'BACKGROUND', 'citation': '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': '36841968', 'type': 'BACKGROUND', 'citation': "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': '28879311', 'type': 'BACKGROUND', 'citation': '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': '33339924', 'type': 'BACKGROUND', 'citation': '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': '17920504', 'type': 'BACKGROUND', 'citation': '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': '34733752', 'type': 'BACKGROUND', 'citation': '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': '31892680', 'type': 'BACKGROUND', 'citation': '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': '23301559', 'type': 'BACKGROUND', 'citation': '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': '18201346', 'type': 'BACKGROUND', 'citation': 'Meechan JG. Intraoral topical anesthesia. Periodontol 2000. 2008;46:56-79. doi: 10.1111/j.1600-0757.2008.00231.x. No abstract available.'}, {'pmid': '26154451', 'type': 'BACKGROUND', 'citation': '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': '31094627', 'type': 'BACKGROUND', 'citation': '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': '28824857', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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).\n\nThe 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.\n\nData 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.\n\nIn 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.\n\nStatistical 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with asymptomatic non pulpally involved carious primary molars who meet the indications of the HT in Dubai Dental Hospital.\n* Children who require same tooth bilateral HT Crowns in either bilateral or diagonal pattern.\n* Healthy male and female children, aged 4-10 years (ASA 1) with no conditions that affect sensory input/reaction.\n* Children who are verbal and able to communicate.\n* Not taking any painkillers, or other drugs that would influence with their pain perception.\n* Cooperative children.\n* Parents or guardians who consent for their children to be enrolled in the trial.\n\nExclusion Criteria:\n\n* Children who are indicated for bilateral HT but do not require EOS, due to pre-existing interdental spaces.\n* Children who are indicated for bilateral HT but parents prefer or indicate preference for the Modified HT.\n* Children with allergies to nickel or other metal components that constitute a PMC.\n* Those with reported allergies to topical or local anesthetic.\n* Children with special health care needs or those who are non-verbal and are unable to communicate their pain levels.\n* Children/parents/guardians not willing to participate in the study.\n* Patients that require treatment under conscious sedation or general anesthesia.'}, 'identificationModule': {'nctId': 'NCT06272903', 'briefTitle': 'Effect of Benzocaine 20% Topical Anesthesia on Pain Levels When Placing Separators in Children Receiving Hall Technique Crowns', 'organization': {'class': 'OTHER', 'fullName': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MBRU IRB-2023-228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benzocaine 20% Topical Anesthesia Arm', 'description': '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.\n\nThe 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.', 'interventionNames': ['Drug: 20% benzocaine, topical anesthetic']}, {'type': 'PLACEBO_COMPARATOR', 'label': "Placebo (Children's Toothpaste) Arm", 'description': "The other side of the mouth will receive a placebo, which consists of children's toothpaste, prior to the placement of elastomeric orthodontic separators.\n\nThe 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.", 'interventionNames': ["Other: Children's Toothpaste"]}], 'interventions': [{'name': '20% benzocaine, topical anesthetic', 'type': 'DRUG', 'description': '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.\n\nThe 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).', 'armGroupLabels': ['Benzocaine 20% Topical Anesthesia Arm']}, {'name': "Children's Toothpaste", 'type': 'OTHER', 'description': "Strawberry-flavored children's toothpaste available in Dubai, UAE.", 'armGroupLabels': ["Placebo (Children's Toothpaste) Arm"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Mohammed Bin Rashid University Of Medicine and Health Sciences', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}], 'overallOfficials': [{'name': 'Simran Kaur Sura', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohammed Bin Rashid University of Medicine and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident - Pediatric Dentistry', 'investigatorFullName': 'Simran Kaur Sura', 'investigatorAffiliation': 'Mohammed Bin Rashid University of Medicine and Health Sciences'}}}}