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

N/ANot Yet RecruitingNCT07733011

Marmara University54 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Molar-Incisor Hypomineralization

Interventions

Computer-Controlled Local AnesthesiaDEVICE

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.

Conventional Local AnesthesiaPROCEDURE

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Immediately following local anesthetic injection at each treatment visit.

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts