Comparing two anesthesia methods for children with dental enamel defects
Evaluation of the Efficacy of Computerized Intraosseous Local Anesthesia System in Children With Molar Incisor Hypomineralization
NA · Istanbul University · NCT06461143
This study tests whether a new type of anesthesia can help children with dental enamel defects feel less pain and anxiety during dental work compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | Istanbul University (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06461143 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intraosseous anesthesia compared to inferior alveolar block anesthesia in children diagnosed with molar incisor hypomineralization (MIH). The study focuses on addressing dental anxiety and pain management during dental procedures, particularly for pediatric patients who may experience heightened sensitivity and anxiety. By utilizing intraosseous anesthesia, which has a rapid onset and minimizes numbness in surrounding areas, the trial seeks to improve the overall dental experience for children. Participants will be assessed based on their cooperation and specific dental needs, ensuring a targeted approach to treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy children aged 6-8 with molar incisor hypomineralization requiring dental restoration.
Not a fit: Patients with systemic health issues or allergies that contraindicate the use of local anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for pediatric dental patients, reducing anxiety and enhancing their overall treatment experience.
How similar studies have performed: Previous studies have shown promising results with intraosseous anesthesia in pediatric dentistry, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals applying the Department of Pedodontics, Istanbul University Faculty of Dentistry, * Systemically healthy, * Without any allergies, * Having at least one mandibular first molar with molar incisor hypomineralization (MIH), * Treatment need index 2 and 4, * Having a radiographically advanced decay lesion involving dentin (outer ½), * Possessing sufficient cooperation skills (Frankl scale 3 and 4), * Between the ages of 6-8, * Both male and female volunteers will be included. Exclusion Criteria: -
Where this trial is running
Istanbul
- Istanbul University, Faculty of Dentistry, Department of Pedodontics — Istanbul, Turkey (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Molar Incisor Hypomineralization, Hypersensitivity, Composite Restoration, dental pain, dental anxiety