Evaluate Buffering Local Anesthetic in Inflamed Teeth

NCT07120594 | Completed DMC

• 1 other identifier: TishreenU Pedodontic
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Buffered local anesthesia; Sodium bicarbonate; Pain during injection; Pediatric dentistry; Tooth extraction

Outcome Measures

Primary Outcomes (3)

• Pain level during tooth extraction in inflamed sites (self-reported)

  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.

  During the tooth extraction procedure

• Pain-related behavioral response during extraction in inflamed primary molars (observer-rated)

  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.

  During the tooth extraction procedure

• Physiological response during extraction in inflamed primary molars (heart rate)

  Heart rate (beats per minute) will be continuously monitored with a pulse oximeter. Increases from baseline are considered indicators of pain/stress during extraction.

  through the extraction procedure

Secondary Outcomes (3)

• Pain perception during injection of anesthetic solution (self-reported)

  During and within 1 minute after anesthetic injection

• Behavioral response during anesthetic injection (SEM)

  During and within 1 minute after anesthetic injection

• Physiological response to injection (heart rate)

  During anesthetic injection

Study Arms (2)

Standard Local Anesthetic

ACTIVE COMPARATOR

Participants receive the standard local anesthetic solution-lidocaine 2% with epinephrine 1:80,000-for extraction of infected and inflamed primary molars.

Drug: Unbuffered lidocaine 2% with epinephrine 1:80,000

Buffered Local Anesthetic

EXPERIMENTAL

Participants receive a buffered local anesthetic solution-lidocaine 2% with epinephrine 1:80,000 buffering with sodium bicarbonate-to assess enhanced anesthetic efficacy during extraction of infected and inflamed primary molars.

Drug: Buffered lidocaine 2% with epinephrine 1:80,000

Interventions

Unbuffered lidocaine 2% with epinephrine 1:80,000 DRUG

Standard local anesthetic solution without pH modification. Used for maxillary extraction of infected primary molars in pediatric patients.

Standard Local Anesthetic

Buffered lidocaine 2% with epinephrine 1:80,000 DRUG

Local anesthetic solution mixed with sodium bicarbonate to increase pH before injection. Used for maxillary extraction of infected primary molars in pediatric patients.

Buffered Local Anesthetic

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tishreen University: lead

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Tishreen University

Latakia, Latakia Governorate, Syria

Location

MeSH Terms

Interventions

Epinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 13, 2025
• Study Start: November 8, 2023
• Primary Completion: July 20, 2025
• Study Completion: July 20, 2025
• Last Updated: August 13, 2025

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)