Buffered Anesthetic Solution in the Treatment of Mandibular Primary Molars
- Conditions
- Local Anesthesia
- Interventions
- Combination Product: Buffered lidocaine in inferior alveolar nerve block injection
- Registration Number
- NCT05793905
- Lead Sponsor
- Damascus University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lidocaine 2% lidocaine 2% in inferior alveolar nerve block injection Control group: Inferior alveolar nerve block with anesthetic solution (Lidocaine 2% with adrenaline 1.80000). Buffered lidocaine Buffered lidocaine in inferior alveolar nerve block injection Inferior alveolar nerve block with buffered anesthetic solution (2% lidocaine with 1/80000 adrenaline mixed with sodium bicarbonate 8.4%)
- Primary Outcome Measures
Name Time Method Probing the gingiva directly after asking the child about lip, tongue numbing every 30 seconds until there is no pain. The onset of anaesthesia at soft tissue will be assessed by probing the gingiva After IANB injection.
Pulse rate 20 seconds after the first quarter of the local anaesthesia. Pulse rate is a physiological pain scale, will be taken through a finger pulse oximeter.
Sound, eye, motor scale (SEM) Within five seconds from the start of the local anesthetic injection to completion Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during anaesthesia
Endo - ice test Every 30 seconds after confirmed soft tissues anaesthesia until the absence of pain. The investigator will use endo-ice to assess the onset time of pulp anaesthesia.
Wong baker faces scale. One minute after IANB injection 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"
- Secondary Outcome Measures
Name Time Method Pulse rate 20 seconds after opening the pulp chamber Pulse rate is a physiological pain scale which will be taken through a finger pulse oximeter.
Wong baker faces scale one minute after preparing pulp chamber 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"
sound, eye, motor scale (SEM) Within five seconds from the start of the local anaesthetic injection to completion Sound, eye, motor scale is an objective pain scale for the assessment of child's behaviour by recording video during endo access preparation
Trial Locations
- Locations (1)
College of dentistry.
🇸🇾Damascus, Al-Mazzeh Saint, Syrian Arab Republic