Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor … (NCT07733011) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization
Turkey (Türkiye)54 participantsStarted 2026-08-11
Plain-language 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.
Who can participate
Age range
8 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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* Children who require pulp treatment after enrollment in the study will be withdrawn from the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Timeframe: Immediately after completion of local anesthetic injection at each treatment visit
2
Injection pain assessed using the Visual Analog Scale (VAS)
Timeframe: Immediately after completion of local anesthetic injection at each treatment visit
3
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Timeframe: Periprocedural (during local anesthetic injection at each treatment visit)
4
Successful local anesthesia during restorative treatment
Timeframe: Immediately after completion of restorative treatment at each treatment visit
5
Absence of response to electric pulp testing
Timeframe: Immediately after completion of local anesthetic injection at each treatment visit
6
Anesthesia Onset Time
Timeframe: Immediately following local anesthetic injection at each treatment visit.