Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization | NCT07733011

NCT07733011

Overview

NCT ID: NCT07733011
Lead Sponsor: Marmara UniversityOTHER
Official Title: Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial
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

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Aug 11, 2026Estimated
Primary Completion Date: Aug 25, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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Children who require pulp treatment after enrollment in the study will be withdrawn from the study.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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 54Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Betül Şen Yavuz, DDSContact
dtbetulsen@gmail.com+905399887646

Similar Studies

Participant Group/Arms

Computer-Controlled Local AnesthesiaExperimental

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 AnesthesiaActive 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