Buffered vs conventional local anesthesia for pain and anxiety during dental treatment in children with pulpitis
Official title: Efficacy of Buffered Versus Conventional Local Anesthesia for Reducing Pain and Anxiety During Dental Treatment in School-Aged Children Diagnosed With Pulpitis: A Randomized Controlled Clinical Trial
Run by Universidad Autonoma de San Luis Potosí · NCT07638254 · Data updated 2026-11-12
This study tests whether buffered local anesthesia reduces pain and anxiety for school-aged children needing dental treatment for pulpitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Universidad Autonoma de San Luis Potosí Academic / other |
| Locations | 1 site (San Luis Potosí City, San Luis Potosí) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | September 2026 |
| Study ends | October 2026 |
| Registry record updated | June 10, 2026 |
| Trial ID | NCT07638254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6 to 12 years with irreversible pulpitis in primary maxillary molars, who are cooperative and fit ASA I and meet consent/assent requirements.
✕Probably not a fit
Children with known allergy to anesthetic components, recent traumatic dental experiences, or non-cooperative behavior may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial compares buffered lidocaine with epinephrine to conventional lidocaine with epinephrine in children aged 6 to 12 undergoing pulpotomy or pulpectomy for irreversible pulpitis in primary maxillary molars. Outcomes include behavioral pain on the FLACC scale, physiological and psychometric indicators of pain and anxiety, and measures of anesthetic onset and duration. Participants are randomized to receive one of the two local anesthetic approaches during routine dental procedures and are observed for safety and effectiveness. The study is conducted at the Universidad Autónoma de San Luis Potosí with a lead sponsor from the same institution.
Why it matters
Potential benefit: If successful, buffered anesthesia could reduce pain and anxiety during dental procedures for children with pulpitis.
How similar studies have gone: Previous research in other settings has suggested buffered anesthetics can reduce pain, but findings are variable across populations and procedures.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged 6 to 12 years * Diagnosis of irreversible pulpitis due to dental caries in primary maxillary molars * American Society of Anesthesiologists (ASA) Physical Status Classification I * Cooperative or definitely cooperative behavior according to Frankl Behavioral Scale (Frankl III or IV) * Written informed consent provided by parent or legal guardian, and child assent when applicable * No use of analgesic or anti-inflammatory medication within 24 hours prior to the procedure Exclusion Criteria: * Known allergy to any component of local anesthetic solution * History of negative or traumatic dental experiences within the previous 12 months that may interfere with behavioral assessment * Radiographic evidence of periapical pathology associated with the affected tooth * Presence of localized abscess or acute spreading infection at the injection site
Where it's running
-
Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí, Mexico Recruiting
Study contacts
- Study coordinator: Mayte A Condori Chambi, Cirujano Dentista
- Email: maytecondori97@gmail.com
- Phone: +524446641295
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using pulpal blood biomarkers to predict success of vital pulp therapy in symptomatic teeth
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This project will see if using bioceramic versus resin-based sealers for root canal fillings changes short-term pain in adults with pulpitis, pulp necrosis, or previously treated teeth.
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This study is testing different ways to treat exposed dental pulp to see which methods work best for adults with teeth that can be saved.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.