Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

In a prospective, randomized clinical trial, triple-blind, split mouth study, 40 children aged between 6 to 10 with bilateral mandibular primary molars diagnosed with pulpitis The test agent will be 2% lidocaine with epinephrine 1:8000 buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which will be non- buffered 2% lidocaine 1:80,000 with epinephrine.

Pain during IANB administration and the effectiveness of anesthesia will be assessed using subjective wong baker visual analogue scale, objective sound, eye, and motor (SEM) scale, and physiological pain scale (pulse rate) using pulse oximeter.

We will confirm the onset of anesthesia after lip, tongue numbing by probing the gingiva until there is no pain.

Endo ice will be used to assess the onset of pulp anesthesia

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Damascus University
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Children who are healthy and free of any underlying conditions that might make local anesthesia impossible to administer.

• Children that are not allergic to (lidocaine, adrenaline, or sodium bicarbonate).

• Children aged 6-10 years old

• Cooperative children on Frankel scale (positive or absolute positive).

• children needing bilateral (right and left) endodontic treatment for the mandibular primary molars.

• A positive outcome on the cold test for the target tooth.

Exclusion Criteria:

• Uncooperative children on Frankel's scale (passive or absolute positive).

• The presence of a fistula.

• The presence of an abscess associated with the target tooth.

• The presence of a periapical lesion radially.

• Negative response to the cold test.

• Children suffering from systemic conditions.

• Children who are allergic to (ledocaine, adrenaline, sodium bicarbonate).