Intraosseous Anesthesia in MIH-Affected Teeth

NCT07457450 | Active Not Recruiting

• 2 other identifiers: 05-PA-30-20-9/2023School of Dental Medicine
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Managing MIH-affected teeth is challenging due to inflammation, sensitivity, rapid caries development, and difficulty achieving anesthesia. This 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. Using a split-mouth model, each child will receive both anesthesia types on different molars, with conventional anesthesia as the control. The study will assess the effectiveness of intraosseous anesthesia in achieving analgesia and reducing anxiety, helping dentists choose the best anesthesia technique.

Conditions

Molar Incisor Hypomineralisation

Keywords

Molar Incisor Hypomineralisation; Intraosseous Anesthesia

Outcome Measures

Primary Outcomes (1)

• Analgesia

  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: 0 = anesthesia insufficient; treatment could not be completed 1. = treatment completed with no pain or sensitivity 2. = treatment completed with mild sensitivity 3. = assessment could not be performed

  During procedure and immediately after, and 2 weeks postoperatively

Secondary Outcomes (5)

• Intraoperative pain

  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.

• Amount of anesthetic solution

  Periprocedural

• Duration of anesthetic application

  Periprocedural, during administration of local anesthesia

• Postoperative complications

  3 weeks

• Evaluation of GIC fillings

  At the 3-month post-treatment control visit

Study Arms (2)

Intraosseous Anesthesia

EXPERIMENTAL

Restorative dental treatment of MIH-affected teeth performed under intraosseous local anesthesia.

Device: Intraosseous anesthesia.

Conventional Local Anesthesia

ACTIVE COMPARATOR

Restorative dental treatment of MIH-affected teeth performed under conventional local infiltration anesthesia.

Device: Local infiltration anesthesia

Interventions

Intraosseous anesthesia. DEVICE

Delivery of local anesthetic solution via intraosseous injection technique prior to restorative treatment.

Intraosseous Anesthesia

Local infiltration anesthesia DEVICE

Delivery of local anesthetic solution using standard infiltration technique prior to restorative treatment.

Conventional Local Anesthesia

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of molar-incisor hypomineralization (MIH)
• At least two first permanent molars affected by MIH
• No prior dental procedures on those molars
• Mentally and physically healthy
• Cooperative behavior (Frankl score 3 or 4)
• No use of analgesics in the 48 hours prior to treatment

You may not qualify if:

• Periodontal changes (e.g., periodontal pockets, tooth mobility)
• Radiographic bone loss, furcation involvement, or periapical radiolucency

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine University of Zagreb

Zagreb, 10 000, Croatia

Location

Related Publications (14)

• 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: 30294157 BACKGROUND

• 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: 19486372 BACKGROUND

• 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: 33876317 BACKGROUND

• 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: 37199855 BACKGROUND

• 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: 34110616 BACKGROUND

• 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: 38629634 BACKGROUND

• 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: 38595428 BACKGROUND

• 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: 37209243 BACKGROUND

• 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: 26058304 BACKGROUND

• 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: 22143722 BACKGROUND

• 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: 30883951 BACKGROUND

• 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: 23063389 BACKGROUND

• 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: 22143716 BACKGROUND

• 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.

  PMID: 26253277 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 9, 2026
• Study Start: October 1, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 30, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)