Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization

July 28, 2026 updated by: Marmara University

Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial

The main questions this study aims to answer are:

Does computer-controlled local anesthesia cause less pain and anxiety than conventional local anesthesia in children with molar-incisor hypomineralization (MIH)?

Is there a difference between the two methods in anesthesia onset time, injection duration, physiological responses, and the need for additional anesthesia?

Researchers will compare computer-controlled and conventional local anesthesia in children aged 8-12 years with MIH. Each child will receive both anesthesia methods during separate dental visits, on comparable permanent molar teeth, to determine which method is more comfortable, effective, and preferred by children.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized split-mouth clinical trial will compare computer-controlled local anesthesia with conventional local anesthesia in children aged 8-12 years with molar-incisor hypomineralization (MIH).

Each child will receive both anesthesia methods during separate restorative treatment visits on comparable affected permanent molars. Pain will be evaluated using child-reported and behavioral pain scales. Dental anxiety, heart rate, oxygen saturation, anesthesia onset time, injection duration, need for additional anesthesia, and patient preference will also be assessed.

The study aims to determine whether computer-controlled local anesthesia provides a more comfortable and effective option than conventional anesthesia for children with MIH.

Study Type

Interventional

Enrollment (Estimated)

54

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 Contact

Study Locations

  • Turkey (Türkiye)
    • Maltepe
      • Istanbul, Maltepe, Turkey (Türkiye), 34854
        • Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
        • Contact:

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

Yes

Description

Inclusion Criteria:

  • Children aged 8-12 years
  • Children with no systemic disease
  • Children with no pathology involving the oral region, such as trauma, cysts, or tumors
  • Children who have not used antibiotics within the past month
  • Children who have not used nonsteroidal anti-inflammatory drugs (NSAIDs) within the past month
  • Children with at least two homologous permanent molars affected by molar-incisor hypomineralization (MIH) and indicated for restorative treatment due to dentin caries
  • Children with a Frankl Behavior Rating Scale score of 3 or higher will be included in the study

Exclusion Criteria:

  • Children in whom local anesthesia cannot be administered due to lack of cooperation
  • Children who require pulp treatment after enrollment in the study will be withdrawn from the study.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer-Controlled Local Anesthesia
Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the injection flow rate and pressure. A 4% articaine solution with 1:100,000 epinephrine will be used before restorative treatment of the MIH-affected permanent molar.
Device: Computer-Controlled Local Anesthesia
Local anesthesia will be administered using the SleeperOne computer-controlled local anesthetic delivery system according to the manufacturer's pediatric protocol. The device electronically controls the flow rate and pressure of the anesthetic solution. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Other Names:
  • SleeperOne
  • Digital Anesthesia
Active Comparator: Conventional Local Anesthesia
Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Procedure: Conventional Local Anesthesia
Local anesthesia will be administered using a conventional dental syringe. Buccal infiltration will be used for maxillary teeth, and an inferior alveolar nerve block will be used for mandibular teeth. A 4% articaine solution with 1:100,000 epinephrine will be administered before restorative treatment of the MIH-affected permanent molar.
Other Names:
  • Traditional Local Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Time Frame: Immediately after completion of local anesthetic injection at each treatment visit
Pain intensity will be assessed during local anesthetic injection using the Wong-Baker Faces Pain Rating Scale (score range: 0-10; higher scores indicate greater pain).
Immediately after completion of local anesthetic injection at each treatment visit
Injection pain assessed using the Visual Analog Scale (VAS)
Time Frame: Immediately after completion of local anesthetic injection at each treatment visit
Pain intensity will be assessed immediately after local anesthetic injection using a 100-mm Visual Analog Scale (0=no pain, 100=worst imaginable pain; higher scores indicate greater pain).
Immediately after completion of local anesthetic injection at each treatment visit
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Time Frame: Periprocedural (during local anesthetic injection at each treatment visit)
Behavioral pain will be assessed during local anesthetic injection using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (score range: 0-10; higher scores indicate greater pain).
Periprocedural (during local anesthetic injection at each treatment visit)
Successful local anesthesia during restorative treatment
Time Frame: Immediately after completion of restorative treatment at each treatment visit
Successful local anesthesia will be defined as completion of cavity preparation and restorative treatment without the need for supplemental local anesthesia and without interruption of treatment because of pain. The outcome will be reported as the percentage of treatment visits with successful local anesthesia.
Immediately after completion of restorative treatment at each treatment visit
Absence of response to electric pulp testing
Time Frame: Immediately after completion of local anesthetic injection at each treatment visit
The proportion of treatment visits in which no response is obtained using an electric pulp tester after local anesthetic administration.
Immediately after completion of local anesthetic injection at each treatment visit
Anesthesia Onset Time
Time Frame: Immediately following local anesthetic injection at each treatment visit.
Anesthesia onset time will be compared between computer-controlled and conventional local anesthesia. It will be defined as the time from completion of the injection until the child reports numbness and no response is obtained with electric pulp testing. The time will be recorded in seconds.
Immediately following local anesthetic injection at each treatment visit.

Collaborators and Investigators

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

Sponsor

Marmara University

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 (Estimated)

August 11, 2026

Primary Completion (Estimated)

August 25, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

July 16, 2026

First Submitted That Met QC Criteria

July 28, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tezasli2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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