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Completed

NCT Number: NCT07120594

Evaluate Buffering Local Anesthetic in Inflamed Teeth

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.

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Dentistry, Faculty of Dentistry, Tishreen University

Latakia, Latakia Governorate, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. Behavioral response during anesthetic injection (SEM)

    Time frame: 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

  3. Physiological response to injection (heart rate)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Latakia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.