Intraosseous Anesthesia in MIH-Affected Teeth (IO-MIH)

March 2, 2026 updated by: Kristina Gorseta, University of Zagreb

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10 000
        • School of Dental Medicine University of Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraosseous Anesthesia
Restorative dental treatment of MIH-affected teeth performed under intraosseous local anesthesia.
Device: Intraosseous anesthesia.
Delivery of local anesthetic solution via intraosseous injection technique prior to restorative treatment.
Active Comparator: Conventional Local Anesthesia
Restorative dental treatment of MIH-affected teeth performed under conventional local infiltration anesthesia.
Device: Local infiltration anesthesia
Delivery of local anesthetic solution using standard infiltration technique prior to restorative treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During procedure and immediately after, and 2 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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
To compare the need for additional amount of anesthetics in IO and conventional anesthesia.
Periprocedural
Duration of anesthetic application
Time Frame: Periprocedural, during administration of local anesthesia
Estimate the time required for the application of IO and conventional anesthesia.
Periprocedural, during administration of local anesthesia
Postoperative complications
Time Frame: 3 weeks
To compare the incidence of postoperative complications with both types of anesthesia.
3 weeks
Evaluation of GIC fillings
Time Frame: At the 3-month post-treatment control visit

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.
At the 3-month post-treatment control visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-PA-30-20-9/2023
  • School of Dental Medicine (Other Identifier: University of Zagreb)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made available due to restrictions related to patient confidentiality and local ethical regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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