Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars

Study Overview
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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.

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.

Official Title
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Evaluation of the Effect of Buffered Anesthetic Solution (Lidocaine 2%) in the Effectiveness of Inferior Alveolar Nerve Block Injection During the Treatment of Mandibular Primary Molars

Conditions
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Local Anesthesia

Intervention / Treatment
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* Combination Product: Buffered lidocaine in inferior alveolar nerve block injection
* Drug: lidocaine 2% in inferior alveolar nerve block injection


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This clinical research aims to evaluate the effectiveness of buffered lidocaine in the treatment of bilateral primary molars
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buffered lidocaine<br>Inferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%) | Combination Product: Buffered lidocaine in inferior alveolar nerve block injection<br>* Buffered Lidocaine 2% with epinephrine 1.80000 mixed with 1.8% sodium bicarbonate in IANB injection in the treatment of bilateral primary mandibular molars<br>* Other names: Buffered lidocaine;|
| Other: Lidocaine 2%<br>Control group: Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000). | Drug: lidocaine 2% in inferior alveolar nerve block injection<br>* Lidocaine 2% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing the gingiva | The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection. | directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain. | 
| Endo - ice test | The investigator will use endo-ice to assess the onset time of pulp anaesthesia. | Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain. | 
| Pulse rate | Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter. | A minute before anaesthesia. | 
| Pulse rate | Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter. | 20 seconds after the first quarter of the local anaesthesia. | 
| Wong baker faces scale. | Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate no hurt to a crying face at 10 to indicate hurts worst | One minute after IANB injection | 
| Sound, eye, motor scale (SEM) | Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during anaesthesia | Within five seconds from the start of the local anesthetic injection to completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse rate | Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter. | 20 seconds after opening the pulp chamber | 
| Wong baker faces scale | Wong Baker faces scale is a subjective pain which contains a series of six faces ranging from a happy face at 0 to indicate no hurt to a crying face at 10 to indicate hurts worst | one minute after preparing pulp chamber | 
| sound, eye, motor scale (SEM) | Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during endo access preparation | Within five seconds from the start of the local anaesthetic injection to completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buffered lidocaine