Molar Incisor Hypomineralisation
Conditions
Keywords
Molar-Incisor Hypomineralization, computer-controlled local anesthetic delivery, intraosseous anesthesia, pediatric dentistry., SleeperOne® 5
Brief summary
This randomized split-mouth clinical trial evaluates whether computer-controlled intraosseous anesthesia delivered with the SleeperOne® 5 system reduces pain perception and dental anxiety compared with conventional local anesthesia during restorative treatment of children with molar-incisor hypomineralization (MIH). Thirty-five children received both anesthesia techniques in separate treatment sessions. Pain perception, behavioral responses, dental anxiety, pulse rate, and oxygen saturation were assessed at predefined time points.
Detailed description
Molar-incisor hypomineralization (MIH) is a developmental enamel defect that frequently presents with hypersensitivity, post-eruptive enamel breakdown, and an increased risk of restorative treatment failure. Achieving effective local anesthesia in children with MIH can be challenging because hypersensitive teeth often exhibit increased pain during anesthetic administration and restorative procedures. These factors may compromise patient cooperation and the quality of dental treatment. Computer-controlled local anesthetic delivery systems have been developed to improve injection comfort by controlling the rate and pressure of anesthetic administration. The SleeperOne® 5 system allows computer-controlled intraosseous anesthesia and may provide more effective pain control than conventional local anesthesia during restorative treatment of MIH-affected teeth. The purpose of this study was to compare SleeperOne® 5-assisted intraosseous anesthesia with conventional local anesthesia in children undergoing restorative treatment of permanent first molars affected by MIH. The study was conducted as a randomized split-mouth clinical trial in which each participant received both anesthetic techniques during separate treatment sessions. The order of the interventions was determined using computer-generated randomization, allowing each participant to serve as his or her own control. All clinical procedures were performed under standardized conditions by the same operator. The study was designed to evaluate whether computer-controlled intraosseous anesthesia could improve pain control and patient comfort during restorative treatment of children with MIH compared with conventional local anesthesia.
Interventions
DEVICESleeperOne® 5 Computer-Controlled Intraosseous Anesthesia
Computer-controlled intraosseous local anesthesia delivered using the SleeperOne® 5 system during restorative treatment of MIH-affected permanent first molars.
PROCEDUREConventional Local Anesthesia
Conventional local anesthesia administered using a standard dental syringe during restorative treatment of MIH-affected permanent first molars.
Sponsors
Ankara University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the obvious differences between the computer-controlled intraosseous anesthesia device (SleeperOne® 5) and the conventional dental syringe, masking of the investigator and participants was not feasible. The same investigator performed both the interventions and the outcome assessments throughout the study.
Intervention model description
A randomized split-mouth design was used in which each participant received both interventions during two separate treatment sessions. One MIH-affected permanent first molar was treated with conventional local anesthesia and the contralateral molar with computer-controlled intraosseous anesthesia delivered using the SleeperOne® 5 system. The order of interventions was determined by computer-generated randomization, allowing each participant to serve as his or her own control.
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 8 to 14 years. * Bilateral symmetrical MIH-affected permanent first molars requiring restorative treatment. * MIH diagnosed according to EAPD criteria. * Positive or definitely positive Frankl Behavior Rating Scale. * Parent or guardian provided written informed consent.
Exclusion criteria
* Acute pulpal or periapical pathology. * Developmental dental anomalies other than MIH. * Allergy to local anesthetic agents. * Medical contraindication to local anesthesia. * Analgesic or anti-inflammatory drug use within 24 hours before treatment. * Cognitive or communication disorders affecting study assessments. * Uncooperative behavior.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Perception During Anesthetic Administration | Immediately after completion of local anesthesia administration (T1) | Pain intensity during local anesthetic administration assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Pain Response | Immediately after completion of local anesthesia administration and immediately after completion of the restorative treatment procedure. | Behavioral pain response assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. The FLACC Scale ranges from 0 to 10, with scores of 0 indicating no pain-related behavioral distress and scores of 10 indicating severe pain-related behavioral distress. Higher scores indicate greater pain-related behavioral distress. |
| Dental Anxiety | Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure. | Dental anxiety assessed using the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). The CFSS-DS score ranges from 15 to 75, with higher scores indicating greater dental anxiety. |
| Pulse Rate | Before local anesthesia administration (T0), immediately after local anesthesia administration (T1), and immediately after restorative treatment (T2). | Physiological response assessed by pulse rate (beats per minute) |
| Peripheral Oxygen Saturation (SpO₂) | Immediately before local anesthesia administration, immediately after completion of local anesthesia administration, and immediately after completion of the restorative treatment procedure. | Physiological response assessed by peripheral oxygen saturation measured by pulse oximetry as a percentage (%). Higher values indicate greater oxygen saturation. |
Countries
Turkey (Türkiye)
Outcome results
None listed