Evaluate Buffering Local Anesthetic in Inflamed Teeth

NCT ID: NCT07120594

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-08
• Study Completion Date: 2025-07-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Local Anesthetic

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

Group Type: ACTIVE_COMPARATOR

Unbuffered lidocaine 2% with epinephrine 1:80,000

Intervention Type: DRUG

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

Buffered Local Anesthetic

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.

Group Type: EXPERIMENTAL

Buffered lidocaine 2% with epinephrine 1:80,000

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tishreen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Pediatric Dentistry, Faculty of Dentistry, Tishreen University

Latakia, Latakia Governorate, Syria

Countries

Syria

Other Identifiers

TishreenU Pedodontic

Identifier Type: -

Identifier Source: org_study_id