NCT07120594

Evaluate Buffering Local Anesthetic in Inflamed Teeth

Evaluate the Effectiveness of Buffering Local Anesthetic With Sodium Bicarbonate in Infected and Inflamed Teeth in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Tishreen University · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blinded, split-mouth clinical trial evaluates the effect of buffering local anesthetic with sodium bicarbonate in pediatric dental extractions. Twenty children aged 6 to 10 years with two infected primary molars on opposite sides of the maxilla participated. Each child received standard anesthetic on one side and buffered anesthetic on the other. Pain levels and onset time were measured to assess anesthetic efficacy.

Detailed description

This randomized, controlled, double-blinded, split-mouth clinical trial aims to evaluate the efficacy of buffering local anesthetic solution with sodium bicarbonate in the extraction of infected and inflamed primary molars in children. Infected tissues tend to have a lower PH , which can limit the effectiveness of local anesthetics by reducing the proportion of the active, non-ionized drug form. buffering with sodium bicarbonate improve anesthetic performance by raising the pH of the solution, enhancing its diffusion and clinical effectiveness. The study included 20 healthy children aged 6 to 10 years, each with two infected or inflamed primary molars located on opposite sides of the maxilla. A split-mouth design was employed, where each child received a standard local anesthetic solution - lidocaine 2% with epinephrine 1:80,000 - on one side, and a buffered solution (alkalinized with sodium bicarbonate) on the contralateral side. To assess anesthetic efficacy, three parameters were measured: pulse rate (as a physiologic indicator of pain), the Sound-Eye-Motor (SEM) scale (for behavioral response), and the Wong-Baker Faces Pain Rating Scale (for subjective pain reporting). Onset time of anesthesia was also recorded. The study aims to determine whether buffering lidocaine with sodium bicarbonate improves pain control and onset time during pediatric dental extractions in inflamed and infected tissues.

Conditions

• Inflamed and Infected Primary Molars in Children
• Effectiveness of Buffered Local Anesthesia During Dental Extraction

Interventions

Type	Name	Description
DRUG	Unbuffered lidocaine 2% with epinephrine 1:80,000	Standard local anesthetic solution without pH modification. Used for maxillary extraction of infected primary molars in pediatric patients.
DRUG	Buffered lidocaine 2% with epinephrine 1:80,000	Local anesthetic solution mixed with sodium bicarbonate to increase pH before injection. Used for maxillary extraction of infected primary molars in pediatric patients.

Timeline

• Start date: 2023-11-08
• Primary completion: 2025-07-20
• Completion: 2025-07-20
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: Syria