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

NCT07733011 | Not Yet Recruiting

• 1 other identifier: tezasli2026
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Molar-Incisor Hypomineralization (MIH); Computer-Controlled Local Anesthesia; Molar-Incisor Hypomineralization

Outcome Measures

Primary Outcomes (6)

• Injection pain assessed using the Wong-Baker Faces Pain Rating Scale

  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)

  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

  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

  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

  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

  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.

Study Arms (2)

Computer-Controlled Local Anesthesia

EXPERIMENTAL

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

Conventional Local Anesthesia

ACTIVE COMPARATOR

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

Interventions

Computer-Controlled Local Anesthesia DEVICE

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.

Also known as: SleeperOne, Digital Anesthesia

Computer-Controlled Local Anesthesia

Conventional Local Anesthesia PROCEDURE

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.

Also known as: Traditional Local Anesthesia

Conventional Local Anesthesia

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar Hypomineralization

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

Central Study Contacts

Betül Şen Yavuz, DDS

CONTACT

+905399887646; dtbetulsen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): August 11, 2026
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)