Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Computer-Controlled Local Anesthesia, Conventional Local Anesthesia.
- Who it may be relevant to
- Registry conditions: Molar-Incisor Hypomineralization, Molar-Incisor Hypomineralization (MIH), Computer-Controlled Local Anesthesia. Basic parameters: 8 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- Injection pain assessed using the Wong-Baker Faces Pain Rating Scale [Time frame: 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]
- Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale [Time frame: 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]
- Absence of response to electric pulp testing [Time frame: 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakül — Istanbul
Identifiers
NCT: NCT07733011 · tezasli2026