Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-04-03

Brief Summary

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In a prospective, randomized clinical trial, triple-blind, split-mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, which was non- buffered 2% lidocaine with 1:80,000 epinephrine. The pain will be assessed during inferior alveolar nerve block injection (IANB) and the effectiveness of anesthesia using the subjective Wong-Baker visual analog scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. The investigator has confirmed the onset of anesthesia after lip tongue-numbing by probing the gingiva until there is no pain. Endo-ice has been used to assess the onset of pulp anesthesia.

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Detailed Description

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In a prospective, randomized clinical trial and triple-blind, split mouth study, 40 children aged between 7 to 10 with bilateral mandibular primary molars were diagnosed with pulpitis. Random numbers between 1 to 40 were assigned to patients, with some receiving buffered lidocaine at their initial appointment while others received unbuffered lidocaine. The solutions have been switched up for the second session, which has been set for one week later. The test agent was 2% lidocaine with 1:80.000 epinephrine buffered with sodium bicarbonate 8.4% at a ratio of 1/10, as opposed to the control agent, non-buffering 2% lidocaine with 1:80,000 epinephrine. Buffered lidocaine has been freshly prepared by mixing sodium bicarbonate (8.4%) with the anaesthetic solution (lidocaine 2% with epinephrine 1/80.000) in a 1:10 ratio by volume. Two percent benzocaine gel is applied at the injection site for one minute before inferior alveolar nerve block injection (IANB). The investigator has assessed pain during IANB injection using the subjective Wong-Baker visual analogue scale, the objective sound, eye, and motor (SEM) scale, and the physiological pain scale (pulse rate) using a pulse oximeter. After administering the IANB injection, the investigator has confirmed the onset of anaesthesia after lip and tongue numbing by probing the gingiva every 30 seconds until there is no pain. Endo-ice has been used to assess the onset of pulp anaesthesia every 30 seconds. The effectiveness of anaesthesia has been assessed during the preparation of the pulp chamber using subjective, objective, and physiological pain scales. Finally, the numerical data will be statistically analysed, and any statistically significant values will be investigated.

Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This clinical research aims to evaluate the effectiveness of buffered lidocaine in the treatment of bilateral primary molars

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple Masking: Patients, Investigators and Statistician

Study Groups

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Buffered lidocaine

Inferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%)

Group Type EXPERIMENTAL

Buffered lidocaine in inferior alveolar nerve block injection

Intervention Type COMBINATION_PRODUCT

Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars

Lidocaine 2%

Control group:

Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000).

Group Type OTHER

lidocaine 2% in inferior alveolar nerve block injection

Intervention Type DRUG

Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars

Interventions

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Buffered lidocaine in inferior alveolar nerve block injection

Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars

Intervention Type COMBINATION_PRODUCT

lidocaine 2% in inferior alveolar nerve block injection

Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars

Intervention Type DRUG

Other Intervention Names

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Buffered lidocaine

Eligibility Criteria

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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 (lidocaine, adrenaline, sodium bicarbonate).

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes