Comparison of Computer-Assisted and Conventional Local Anesthesia in Children With Molar-Incisor Hypomineralization: A Split-Mouth Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Marmara University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Injection pain assessed using the Wong-Baker Faces Pain Rating Scale
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Time Frame: Immediately after completion of local anesthetic injection at each treatment visit
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).
Injection pain assessed using the Visual Analog Scale (VAS)
Time Frame: Immediately after completion of local anesthetic injection at each treatment visit
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).
Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale
Time Frame: Periprocedural (during local anesthetic injection at each treatment visit)
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).
Successful local anesthesia during restorative treatment
Time Frame: Immediately after completion of restorative treatment at each treatment visit
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.
Absence of response to electric pulp testing
Time Frame: Immediately after completion of local anesthetic injection at each treatment visit
The proportion of treatment visits in which no response is obtained using an electric pulp tester after local anesthetic administration.
Anesthesia Onset Time
Time Frame: Immediately following local anesthetic injection at each treatment visit.
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.
Secondary Outcomes
No secondary outcomes reported