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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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% with epinephrine 1.80000 in IANB injection in the treatment of bilateral primary mandibular molars
College of dentistry.
Damascus, Al-Mazzeh Saint, Syria
Probing the gingiva
The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection.
Time frame: 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.
Time frame: 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.
Time frame: A minute before anaesthesia.
Pulse rate
Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter.
Time frame: 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"
Time frame: 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
Time frame: Within five seconds from the start of the local anesthetic injection to completion
Pulse rate
Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.
Time frame: 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"
Time frame: 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
Time frame: Within five seconds from the start of the local anaesthetic injection to completion
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