Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:02 PM
Study NCT ID:
NCT07457450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraosseous Anesthesia in MIH-Affected Teeth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094604', 'term': 'Molar Hypomineralization'}], 'ancestors': [{'id': 'D000094603', 'term': 'Dental Enamel Hypomineralization'}, {'id': 'D000094602', 'term': 'Developmental Defects of Enamel'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia', 'timeFrame': 'During procedure and immediately after, and 2 weeks postoperatively', 'description': 'The primary objective is to compare the effectiveness of intraosseous anesthesia versus conventional local anesthesia in achieving analgesia during restorative procedures on MIH-affected first permanent molars in children aged 6 to 14 years. Each tooth will be assigned a score according to this scale by another trained dentist at the end of each procedure:\n\n0 = anesthesia insufficient; treatment could not be completed\n\n1. = treatment completed with no pain or sensitivity\n2. = treatment completed with mild sensitivity\n3. = assessment could not be performed'}], 'secondaryOutcomes': [{'measure': 'Intraoperative pain', 'timeFrame': 'FIS and VAS scales- before and immediately after anesthesia. Objective assessment of pain during anesthetic administration. The heart rate will be measured before and during the application of anesthesia, and during the restaurative treatment.', 'description': "To compare the presence and intensity of pain during application of IO anesthesia compared to conventional anesthesia.\n\nThe intensity of pain will be assessed using the FIS (Facial Image Scale) and VAS (Visual Analogue Scale) scales before and immediately after anesthesia.\n\nObjective assessment of pain during anesthetic administration will be performed using a modified behavioral pain scale. The child's response to pain will be evaluated based on the presence or absence of arm or leg movements, torso movements, oral physical resistance (e.g., reluctance to open the mouth when requested), crying, raised eyebrows, and narrowing of the eyes. Each observed reaction will be scored as 1 (present) or 0 (absent), and the scores will be summed to obtain a total behavioral pain score for each patient. During all procedures, heart rate will be measured with a pulse oximeter."}, {'measure': 'Amount of anesthetic solution', 'timeFrame': 'Periprocedural', 'description': 'To compare the need for additional amount of anesthetics in IO and conventional anesthesia.'}, {'measure': 'Duration of anesthetic application', 'timeFrame': 'Periprocedural, during administration of local anesthesia', 'description': 'Estimate the time required for the application of IO and conventional anesthesia.'}, {'measure': 'Postoperative complications', 'timeFrame': '3 weeks', 'description': 'To compare the incidence of postoperative complications with both types of anesthesia.'}, {'measure': 'Evaluation of GIC fillings', 'timeFrame': 'At the 3-month post-treatment control visit', 'description': 'The clinical evaluation of the restorations will be performed at the 3-month follow-up visit. Each restoration will be assessed for its appearance, integrity, and longevity using the United States Public Health Service (USPHS) criteria, which include assessment of color match, surface texture, marginal adaptation, anatomical form, and presence of secondary caries. Each parameter will be scored as follows:\n\n* A (Alpha) - ideal, excellent performance\n* B (Bravo) - clinically acceptable, minor deviations\n* C (Charlie) - clinically unacceptable, major deviations\n* D (Delta) - complete failure of the restoration Lower letter scores (A = Alpha) indicate better clinical performance, whereas higher letter scores (C = Charlie, D = Delta) indicate worse outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Molar Incisor Hypomineralisation', 'Intraosseous Anesthesia'], 'conditions': ['Molar Incisor Hypomineralisation']}, 'referencesModule': {'references': [{'pmid': '30294157', 'type': 'BACKGROUND', 'citation': 'Dixit UB, Joshi AV. Efficacy of Intraosseous Local Anesthesia for Restorative Procedures in Molar Incisor Hypomineralization-Affected Teeth in Children. Contemp Clin Dent. 2018 Sep;9(Suppl 2):S272-S277. doi: 10.4103/ccd.ccd_252_18.'}, {'pmid': '19486372', 'type': 'BACKGROUND', 'citation': 'Sixou JL, Marie-Cousin A, Huet A, Hingant B, Robert JC. Pain assessment by children and adolescents during intraosseous anaesthesia using a computerized system (QuickSleeper). Int J Paediatr Dent. 2009 Sep;19(5):360-6. doi: 10.1111/j.1365-263X.2009.00983.x. Epub 2009 Apr 14.'}, {'pmid': '33876317', 'type': 'BACKGROUND', 'citation': 'Bekes K, Amend S, Priller J, Zamek C, Stamm T, Kramer N. Changes in oral health-related quality of life after treatment of hypersensitive molar incisor hypomineralization-affected molars with a sealing. Clin Oral Investig. 2021 Nov;25(11):6449-6454. doi: 10.1007/s00784-021-03947-z. Epub 2021 Apr 20.'}, {'pmid': '37199855', 'type': 'BACKGROUND', 'citation': 'Vicioni-Marques F, Carvalho MR, Raposo F, de Paula-Silva FWG, de Queiroz AM, Leal SC, Manton DJ, de Carvalho FK. Association of dental hypersensitivity and anxiety in children with molar-incisor hypomineralisation (MIH). Eur Arch Paediatr Dent. 2023 Jun;24(3):313-319. doi: 10.1007/s40368-023-00803-4. Epub 2023 May 18.'}, {'pmid': '34110616', 'type': 'BACKGROUND', 'citation': 'Jalevik B, Sabel N, Robertson A. Can molar incisor hypomineralization cause dental fear and anxiety or influence the oral health-related quality of life in children and adolescents?-a systematic review. Eur Arch Paediatr Dent. 2022 Feb;23(1):65-78. doi: 10.1007/s40368-021-00631-4. Epub 2021 Jun 10.'}, {'pmid': '38629634', 'type': 'BACKGROUND', 'citation': 'Muller-Bolla M, Aiem E, Joseph C, Davit-Beal T, Marquillier T, Esclassan E, Delfosse C, Lopez S, Velly AM. Pain during primary molar local anaesthesia with SleeperOne5 computerized device versus conventional syringe: A randomized, split-mouth, crossover, controlled trial. Int J Paediatr Dent. 2024 Nov;34(6):891-905. doi: 10.1111/ipd.13189. Epub 2024 Apr 17.'}, {'pmid': '38595428', 'type': 'BACKGROUND', 'citation': 'Dixit A, Randhawa RK, Randhawa GS, Solanki P, Takvani R, Vaghela I. Comparative Analysis of Local Anesthetic Techniques for Pain Management in Pediatric Dental Procedures: A Randomized Clinical Trial. J Pharm Bioallied Sci. 2024 Feb;16(Suppl 1):S196-S198. doi: 10.4103/jpbs.jpbs_454_23. Epub 2023 Nov 7.'}, {'pmid': '37209243', 'type': 'BACKGROUND', 'citation': "Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29."}, {'pmid': '26058304', 'type': 'BACKGROUND', 'citation': 'Cabasse C, Marie-Cousin A, Huet A, Sixou JL. Computer-assisted intraosseous anaesthesia for molar and incisor hypomineralisation teeth. A preliminary study. Odontostomatol Trop. 2015 Mar;38(149):5-9.'}, {'pmid': '22143722', 'type': 'BACKGROUND', 'citation': 'Beneito-Brotons R, Penarrocha-Oltra D, Ata-Ali J, Penarrocha M. Intraosseous anesthesia with solution injection controlled by a computerized system versus conventional oral anesthesia: a preliminary study. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e426-9. doi: 10.4317/medoral.17543.'}, {'pmid': '30883951', 'type': 'BACKGROUND', 'citation': 'Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.'}, {'pmid': '23063389', 'type': 'BACKGROUND', 'citation': 'Ozer S, Yaltirik M, Kirli I, Yargic I. A comparative evaluation of pain and anxiety levels in 2 different anesthesia techniques: locoregional anesthesia using conventional syringe versus intraosseous anesthesia using a computer-controlled system (Quicksleeper). Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Nov;114(5 Suppl):S132-9. doi: 10.1016/j.oooo.2011.09.021. Epub 2012 May 6.'}, {'pmid': '22143716', 'type': 'BACKGROUND', 'citation': 'Penarrocha-Oltra D, Ata-Ali J, Oltra-Moscardo MJ, Penarrocha-Diago M, Penarrocha M. Side effects and complications of intraosseous anesthesia and conventional oral anesthesia. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e430-4. doi: 10.4317/medoral.17512.'}, {'pmid': '26253277', 'type': 'BACKGROUND', 'citation': 'Sixou JL, Marie-Cousin A. Intraosseous anaesthesia in children with 4 % articaine and epinephrine 1:400,000 using computer-assisted systems. Eur Arch Paediatr Dent. 2015 Dec;16(6):477-81. doi: 10.1007/s40368-015-0197-5. Epub 2015 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'Managing MIH-affected teeth is challenging due to inflammation, sensitivity, rapid caries development, and difficulty achieving anesthesia.\n\nThis study aims to compare the effectiveness of intraosseous and conventional anesthesia in providing analgesia during restorations of MIH-affected molars in children aged 6-14.\n\nUsing a split-mouth model, each child will receive both anesthesia types on different molars, with conventional anesthesia as the control.\n\nThe study will assess the effectiveness of intraosseous anesthesia in achieving analgesia and reducing anxiety, helping dentists choose the best anesthesia technique.', 'detailedDescription': "Introduction. Molar-incisor hypomineralization (MIH) is a qualitative defect in the development of the enamel that affects at least one first permanent molar (FPM), often also impacting permanent incisors. Although MIH is considered to be an idiopathic condition, its concise etiology remains unclear. The porous nature of MIH enamel and the presence of post-eruptive enamel breakdown leads to hypersensitivity and pain, which is often the patient's main complaint and can affect the quality of life. There is also the increased risk of dental fear and anxiety.\n\nDental anaesthesia, because it is mainly associated with pain, is one of the most important factors related to fear and discomfort in children and adolescents. The delivery of local anaesthetic solutions and the puncturing the mucosa by the needle during traditional infiltration procedures can be uncomfortable in spite of topical anaesthesia and computerized systems to deliver the anaesthetic at a constant rate and pressure. Infiltration methods (buccal infiltration, mandibular nerve block, etc.) may also be associated with mucosal numbing and self-biting of soft-tissues.\n\nClinical management of young patients with MIH-affected teeth becomes challenging due to chronic subclinical inflammation caused by ingress of bacteria in the exposed dentin, sensitivity and rapid caries development in the affected teeth, difficulty in achieving local anesthesia as a result of altered nerve potential, and limited cooperation of the young child due to hypersensitivity-related apprehension.\n\nIn the case of MIH, clinicians might be tempted to give a greater than usual dose of anesthetic to overcompensate for the hyper-reactive tooth. Treating a pediatric population limits anesthetic administration by weight and age, so the practitioner may reach the maximum dose before the desired anesthetic effect is achieved. An alternative anesthesia technique, which has been more widely used in endodontics, is the intraosseous injection.\n\nIntraosseous (IO) injections consist of injecting local anaesthetic directly in the cancellous bone adjacent to any tooth to be anaesthetised. Since the anesthetic solution is targeted directly to the tooth requiring treatment, the surrounding soft tissues are usually not affected. Unlike other IO injections, Quicksleeper (Dental Hi-Tec, Cholet France) is a computer-controlled anesthetic system. Because there is an array of carriers and needles which serve a variety of different purposes, it is possible to administer IO injection (transcortical, osteocentral), periodontal ligament injection (PLE), intraseptal injections, infiltration, and nerve block anesthetics in this system. Owing to its asymmetric triple bevel, the needle tip makes possible a painless and easy perforation into the bone.\n\nAlso, pain during injection would be decreased because IO anesthesia can be delivered by a computerized system (QuickSleeper™ system), which delivers local anaesthesia at a constant rate and pressure. Indeed, some authors showed that 83.9% of 50 children felt no pain or only mild discomfort with QuickSleeper™ system (scores 0 to 2 on the visual analogue scale \\[VAS\\]), and that 69.7% of 30 patients preferred IOA compared to CIA.\n\nAim This study aimes to compare the effectiveness of intraosseous (IO) and conventional anesthesia in providing analgesia during restorative procedures for molars affected by MIH in children between the ages of 6 and 14 years.\n\nThe study will be conducted at a tertiary pediatric dental care center and will follow strict ethical guidelines in accordance with the Declaration of Helsinki, with prior approval from the institutional Ethics Committee.\n\nEligible participants will undergo restorative procedures on two first permanent molars affected by MIH. The study will employ a split-mouth design, where each child will receive IO anesthesia for one molar and conventional local anesthesia for the other, with treatment sessions scheduled 7 to 21 days apart. IO anesthesia will be delivered using the QuickSleeper™ system, while conventional anesthesia will be administered according to standard dental protocols. The administration technique, including needle insertion, depth, and injection speed, will be standardized to ensure consistency across participants. One clinician will perform all procedures. An assistant will record the duration of anesthesia application, from the moment the topical anesthetic is applied to the end of the anesthetic injection. Anesthesia onset will be assessed using cold air (air blower, cold test) at 5, 10, 30, and 60-second intervals. Heart rate will be monitored throughout the procedure using a pulse oximeter. Pain intensity will be assessed before and after anesthesia and restorative treatment.\n\nThe study will include a convenience sample of 50 patients. Literature review supports this sample size based on comparable study outcomes.\n\nPrior to each treatment session, the child's behavior will be assessed using the Frankl behavior scale. All participants will complete the CMDAS questionnaire to evaluate anxiety before the procedure. An orthopantomogram (panoramic X-ray) will be performed to exclude periapical pathology and to ensure there is sufficient space for intraosseous needle placement. Baseline data will include age, gender, presence of MIH on the first permanent molars, tooth sensitivity complaints, and Frankl behavior scale rating. At the first visit, participants will receive intraosseous local anesthesia using the QuickSleeper™ system (Dental Hi Tec, Cholet, France).\n\nParticipants. The participants will be children aged 6 to 14 from Croatia referred to the Department of Paediatric and Preventive Dentistry at the School of Dental Medicine, University of Zagreb, and diagnosed with MIH through a specialist examination.\n\nThis trial will provide a comprehensive evaluation of IO versus conventional anesthesia in MIH-affected pediatric patients, combining technical procedural details with standardized clinical and behavioral assessments to generate clinically relevant and reproducible outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of molar-incisor hypomineralization (MIH)\n* At least two first permanent molars affected by MIH\n* No prior dental procedures on those molars\n* Mentally and physically healthy\n* Cooperative behavior (Frankl score 3 or 4)\n* No use of analgesics in the 48 hours prior to treatment\n\nExclusion Criteria:\n\n* Periodontal changes (e.g., periodontal pockets, tooth mobility)\n* Radiographic bone loss, furcation involvement, or periapical radiolucency'}, 'identificationModule': {'nctId': 'NCT07457450', 'acronym': 'IO-MIH', 'briefTitle': 'Intraosseous Anesthesia in MIH-Affected Teeth', 'organization': {'class': 'OTHER', 'fullName': 'University of Zagreb'}, 'officialTitle': 'Evaluating the Effectiveness of Intraosseous Anesthesia During Restorative Procedures on Teeth Affected by Molar Incisive Hypomineralization in Children', 'orgStudyIdInfo': {'id': '05-PA-30-20-9/2023'}, 'secondaryIdInfos': [{'id': 'School of Dental Medicine', 'type': 'OTHER', 'domain': 'University of Zagreb'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraosseous Anesthesia', 'description': 'Restorative dental treatment of MIH-affected teeth performed under intraosseous local anesthesia.', 'interventionNames': ['Device: Intraosseous anesthesia.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Local Anesthesia', 'description': 'Restorative dental treatment of MIH-affected teeth performed under conventional local infiltration anesthesia.', 'interventionNames': ['Device: Local infiltration anesthesia']}], 'interventions': [{'name': 'Intraosseous anesthesia.', 'type': 'DEVICE', 'description': 'Delivery of local anesthetic solution via intraosseous injection technique prior to restorative treatment.', 'armGroupLabels': ['Intraosseous Anesthesia']}, {'name': 'Local infiltration anesthesia', 'type': 'DEVICE', 'description': 'Delivery of local anesthetic solution using standard infiltration technique prior to restorative treatment.', 'armGroupLabels': ['Conventional Local Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10 000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'School of Dental Medicine University of Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be made available due to restrictions related to patient confidentiality and local ethical regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zagreb', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kristina Gorseta', 'investigatorAffiliation': 'University of Zagreb'}}}}