A Phase 2 interventional study of conventional 2% lignocaine at room temperature and pre-warmed 2% lignocaine at 42°C in Success of Inferior Alveolar Nerve Block and Inferior Alveolar Nerve Block, sponsored by Armed Forces Institute of Dentistry, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-03.
Sponsored by Armed Forces Institute of Dentistry, Pakistan · Phase 2, Interventional, and Treatment
The study compares the anesthetic efficacy of warm versus conventional 2% lignocaine for inferior alveolar nerve block in mandibular molars, evaluating success rates and onset time.
The study will be conducted following approval from the Institutional Ethics Review Committee, AFID (ANX "A"). A total of 200 eligible patients visiting the Operative Dentistry Department at the Armed Forces Institute of Dentistry will be invited to participate. The procedure will be explained to the patients in Urdu, and written informed consent will be obtained (ANX "B").
Patients will be screened for eligibility through medical history, clinical examination, necessary tests, and peri-apical radiographs. Those meeting the inclusion criteria will be randomly assigned to one of two groups using a scientific random number table.
Group 1: Patients will receive conventional 2% lignocaine (at room temperature).
Group 2: Patients will receive pre-warmed 2% lignocaine (at 42°C). Root canal treatment will begin after the inferior alveolar nerve block (IANB) is administered. 1.8 mL of the local anesthetic will be delivered over 60 seconds using a 27-gauge needle. The first investigator will randomize participants by having them choose one of two differently colored balls to determine which anesthetic preparation (conventional or pre-warmed) they will receive. The conventional 2% lignocaine will be commercially available 2% lignocaine hydrochloride with 1:200,000 epinephrine, while the pre-warmed solution will be heated in a thermostatically controlled water bath or feeder bottle warmer (Philips AVENT) to 42°C.
The second investigator, who will be blinded to group allocation, will evaluate pain immediately after the block is administered by asking patients to rate their discomfort on a Visual Analog Scale (VAS). The onset of anesthesia will also be measured by performing gingival probing every 15 seconds. After rubber dam isolation, access cavity preparation will be performed, and pulp therapy will be initiated by the first investigator. The pulp therapy will be completed as needed, and the teeth will be restored with light-cured composite resin.
Armed Forces Institute of Dentistry, Pakistan is the lead sponsor of 27 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Group 1: Patients receive conventional 2% lignocaine at room temperature.
Drug: conventional 2% lignocaine at room temperature
Group 2: Patients receive pre-warmed 2% lignocaine at 42°C
Drug: pre-warmed 2% lignocaine at 42°C
This study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars
This study aims to compare the effectiveness of warm 2% lignocaine (lidocaine) versus conventional room temperature 2% lignocaine for achieving successful inferior alveolar nerve blocks (IANB) in mandibular permanent molars
Pain during administration of injection
Pain during administration of injection with 2% conventional and warm lignocaine on visual analogue scale is assessed. Visual Analog Scale, which is a tool used to measure a patient's perception of pain. It typically consists of a line, often 10 cm long, where one end represents "no pain" and the other end represents "worst possible pain." The patient marks a point on the line that corresponds to their level of pain. The distance from the "no pain" end to the point marked by the patient is then measured, usually in centimeters or millimeters, to quantify the pain intensity. Visual Analog Scale is commonly used in clinical trials to assess pain during and after procedures, as it provides a simple and reliable method for evaluating pain intensity.
Time frame: 60 seconds
Onset of anesthesia in seconds
It will be measured by gingival probing every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application) It will be done by using both conventional and warm 2% lignocaine.
Time frame: Every 15 seconds till patient reports no sensation after stimulus (assessed up to 15 minutes after anesthesia application)
Plan to share: No
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Armed Forces Institute of Dentistry, Pakistan