Evaluate Buffering Local Anesthetic in Inflamed Teeth

Not Applicable

Completed

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

• Registration Number: NCT07120594
• Lead Sponsor: Tishreen University

Brief 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.

Study Timeline

• Status Verified: 2023-10
• Study Start: 2023-11-08
• Primary Completion: 2025-07-20
• Study Completion: 2025-07-20
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-08-12
• Last Update Submitted: 2025-08-12
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Children aged 6 to 10 years with bilateral maxillary first or second primary molars indicated for extraction due to infection and inflammation.
2. Presence of clinical signs of inflammation (e.g., redness, swelling) in the gingiva surrounding the affected teeth.
3. Medically healthy children with no systemic diseases or cognitive disabilities.
4. Children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale.
5. No intake of medications that may interfere with pain perception during the 24 hours preceding the treatment session.

Exclusion Criteria

1. Presence of systemic medical conditions.
2. Children with negative or definitely negative behavior according to the Frankl Behavior Rating Scale.
3. Known allergy to the local anesthetic agent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain level during tooth extraction in inflamed sites (self-reported)	During the tooth extraction procedure	Procedural pain during extraction was assessed using the Wong-Baker FACES Pain Rating Scale to measure children's self-reported pain. This scale uses six cartoon faces representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children were asked to indicate the face that best matched their pain level during tooth extraction in inflamed areas. Higher scores indicate greater pain intensity.
Pain-related behavioral response during extraction in inflamed primary molars (observer-rated)	During the tooth extraction procedure	Procedural pain behavior will be assessed using the Sound-Eye-Motor (SEM) scale. Trained observers will score behavioral responses during extraction; higher scores indicate stronger pain-related behavior.
Physiological response during extraction in inflamed primary molars (heart rate)	through the extraction procedure	Heart rate (beats per minute) will be continuously monitored with a pulse oximeter. Increases from baseline are considered indicators of pain/stress during extraction.

Secondary Outcome Measures

Name	Time	Method
Pain perception during injection of anesthetic solution (self-reported)	During and within 1 minute after anesthetic injection	Pain during injection will be self-reported using the Wong-Baker FACES Pain Rating Scale. Children indicate the face that best matches injection pain (0-10)
Behavioral response during anesthetic injection (SEM)	During and within 1 minute after anesthetic injection	Observer-rated SEM scores will be recorded during anesthetic injection to evaluate behavioral response to injection pain
Physiological response to injection (heart rate)	During anesthetic injection	Heart rate (beats per minute) will be recorded before, during, and immediately after injection. Changes from baseline will be used as an objective marker of pain/stress

Trial Locations

Locations (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Tishreen University; 🇸🇾 Latakia, Lattakia, Syrian Arab Republic