Evaluate Buffering Local Anesthetic in Inflamed Teeth

Tishreen University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07120594

TishreenU Pedodontic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Standard Local Anesthetic

Active Comparator group

Description:

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

Treatment:

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

Buffered Local Anesthetic

Experimental group

Description:

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.

Treatment:

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