Molar Incisor HypomineralisationIO-MIHNCT07457450
Intraosseous Anesthesia in MIH-Affected Teeth
A study testing Intraosseous anesthesia. and Local infiltration anesthesia in people with Molar Incisor Hypomineralisation, run by University of Zagreb at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Molar Incisor Hypomineralisation
- What is being tested?
- Intraosseous anesthesia. and Local infiltration anesthesia
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Oct 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Periodontal changes (e.g., periodontal pockets, tooth mobility)
- Radiographic bone loss, furcation involvement, or periapical radiolucency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Intraosseous Anesthesia During Restorative Procedures on Teeth Affected by Molar Incisive Hypomineralization in Children
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.
Read the detailed description
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.
Dental 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.
Clinical 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.
In 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.
Intraosseous (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.
Also, 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.
Aim 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.
The 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.
Eligible 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.
The study will include a convenience sample of 50 patients. Literature review supports this sample size based on comparable study outcomes.
Prior 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).
Participants. 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.
This 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.
- Conditions
- Molar Incisor Hypomineralisation
- Being tested
- Intraosseous anesthesia., Local infiltration anesthesia
- Keywords
- Molar Incisor Hypomineralisation, Intraosseous Anesthesia
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous anesthesia.Device
Delivery of local anesthetic solution via intraosseous injection technique prior to restorative treatment.
Local infiltration anesthesiaDevice
Delivery of local anesthetic solution using standard infiltration technique prior to restorative treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Anesthesia | Experimental | Restorative dental treatment of MIH-affected teeth performed under intraosseous local anesthesia. Receives: Device: Intraosseous anesthesia. |
| Conventional Local Anesthesia | Active comparator | Restorative dental treatment of MIH-affected teeth performed under conventional local infiltration anesthesia. Receives: Device: Local infiltration anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = treatment completed with no pain or sensitivity
- = treatment completed with mild sensitivity
- = assessment could not be performed
Measured: During procedure and immediately after, and 2 weeks postoperatively
Secondary outcomes (5)
Intraoperative pain
To compare the presence and intensity of pain during application of IO anesthesia compared to conventional anesthesia.
The intensity of pain will be assessed using the FIS (Facial Image Scale) and VAS (Visual Analogue Scale) scales before and immediately after anesthesia.
Objective 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.
Measured: 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
To compare the need for additional amount of anesthetics in IO and conventional anesthesia.
Measured: Periprocedural
Duration of anesthetic application
Estimate the time required for the application of IO and conventional anesthesia.
Measured: Periprocedural, during administration of local anesthesia
Postoperative complications
To compare the incidence of postoperative complications with both types of anesthesia.
Measured: 3 weeks
Evaluation of GIC fillings
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:
- A (Alpha) - ideal, excellent performance
- B (Bravo) - clinically acceptable, minor deviations
- C (Charlie) - clinically unacceptable, major deviations
- 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.
Measured: At the 3-month post-treatment control visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Oct 2023
- Primary completionApr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Gorseta, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457450
- Sponsor's protocol ID
- 05-PA-30-20-9/2023
- Other IDs
- School of Dental Medicine
- Acronym
- IO-MIH
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available due to restrictions related to patient confidentiality and local ethical regulations.
Publications
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.
PubMed 30294157Sixou 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.
PubMed 19486372Bekes 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.
PubMed 33876317Vicioni-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.
PubMed 37199855Jalevik 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.
PubMed 34110616Muller-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.
PubMed 38629634Dixit 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.
PubMed 38595428Gaudin 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.
PubMed 37209243Cabasse 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.
PubMed 26058304Beneito-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.
PubMed 22143722Smail-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.
PubMed 30883951Ozer 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.
PubMed 23063389Penarrocha-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.
PubMed 22143716Sixou 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.
PubMed 26253277Muzinic K, P Vucak J, Skrinjaric T, Stojanovic J, Galic T, Glavina D, Juric H, Gorseta K. Assessment of the effectiveness of intraosseous anaesthesia during restorative procedures on teeth affected by molar incisor hypomineralisation in children. Eur Arch Paediatr Dent. 2026 Sep 8. doi: 10.1007/s40368-026-01276-x. Online ahead of print.
PubMed 42709399
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Intraosseous Anesthesia During Restorative Procedures on Teeth Affected by Molar Incisive Hypomineralization in Children
- ClinicalTrials.gov ID
- NCT07457450
- Acronym / sponsor ID
- IO-MIH / 05-PA-30-20-9/2023
- Conditions
- Molar Incisor Hypomineralisation
- Keywords
- Molar Incisor Hypomineralisation, Intraosseous Anesthesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Dental 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.
Clinical 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.
In 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.
Intraosseous (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.
Also, 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.
Aim 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.
The 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.
Eligible 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.
The study will include a convenience sample of 50 patients. Literature review supports this sample size based on comparable study outcomes.
Prior 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).
Participants. 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.
This 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Anesthesia | Experimental | Device: Intraosseous anesthesia.Restorative dental treatment of MIH-affected teeth performed under intraosseous local anesthesia. |
| Conventional Local Anesthesia | Active comparator | Device: Local infiltration anesthesiaRestorative dental treatment of MIH-affected teeth performed under conventional local infiltration anesthesia. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- Periodontal changes (e.g., periodontal pockets, tooth mobility)
- Radiographic bone loss, furcation involvement, or periapical radiolucency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraosseous anesthesia.Delivery of local anesthetic solution via intraosseous injection technique prior to restorative treatment. | Device | Intraosseous Anesthesia |
| Local infiltration anesthesiaDelivery of local anesthetic solution using standard infiltration technique prior to restorative treatment. | Device | Conventional Local Anesthesia |
Primary outcome
Analgesia
Time frame: During procedure and immediately after, and 2 weeks postoperatively
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
5 secondary outcomes
Intraoperative pain
Time frame: 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
Time frame: Periprocedural
Duration of anesthetic application
Time frame: Periprocedural, during administration of local anesthesia
Postoperative complications
Time frame: 3 weeks
Evaluation of GIC fillings
Time frame: At the 3-month post-treatment control visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Background: PubMed 30294157Dixit 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.
- Background: PubMed 19486372Sixou 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.
- Background: PubMed 33876317Bekes 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.
- Background: PubMed 37199855Vicioni-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.
- Background: PubMed 34110616Jalevik 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.
- Background: PubMed 38629634Muller-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.
- Background: PubMed 38595428Dixit 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.
- Background: PubMed 37209243Gaudin 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.
- Background: PubMed 26058304Cabasse 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.
- Background: PubMed 22143722Beneito-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.
- Background: PubMed 30883951Smail-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.
- Background: PubMed 23063389Ozer 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.
- Individual participant dataSharing planned: No. Individual participant data will not be made available due to restrictions related to patient confidentiality and local ethical regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous anesthesia. and Local infiltration anesthesia in people with Molar Incisor Hypomineralisation, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia (time frame: During procedure and immediately after, and 2 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07457450, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.