Analgesic efficacy of 2% Lignocaine and 4% Articaine with or withoutMagnesium Sulfate for inferior alveolar nerve block in irreversible pulpitis andapical periodontitis -A Randomized Clinical trail
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- anesthetic and post operative analgesic efficacy expected with addition of magnesium sulfate
Study Overview
Brief Summary
AIM: To evaluate the onset, duration, anesthetic efficacy and post operative
analgesia of 2% Lignocaine and 4% Articaine with or without Magnesium Sulfate
for inferior alveolar nerve block in irreversible pulpitis and apical periodontitis.
METHODOLOGY :Patients classified under the American Society of
Anaesthesiologists (ASA) categories I and II, within the age groups of 20 to 60
years will be screened in the study. 44 patients diagnosed with symptomatic
irreversible pulpitis and apical periodontitis were selected
Study protocol will be explained to the patients and informed consent will be
obtained from those willing to participate. The patients are free to withdraw
anytime during the study. Pre-operative vitals and Heft Parker–Visual Analogue
Scale (HP-VAS) pain scores will be recorded before starting the procedure.Page 2 of 11
The patients are (Block randomization) randomly divided into four groups,each
group containing 11 patients
Group 1- 2% lidocaine with 1:80,000 epinephrine
Group 2- 2% lidocaine with epinephrine 1:80,000 and 75 mg MgSo4
Group 3 -4% articaine with epinephrine 1:1,00,000 and 75mg MgSo4
Group 4-4% articaine with epinephrine 1:1,00,000
The onset of anaesthesia will be evaluated by EPT for every 1 min until the
corresponding vital tooth stops responding. Lip numbness will be considered to
check the aesthetic success within 15 minutes.The duration of anaesthesia will be
evaluated every 15 min using EPT till the adjacent normal tooth responded on the
working side.
In case of pain supplementary injection will be provided and the patient will be
ruled out the study.
Pain data will be collected after access cavity and insertion of files in the canals.
The post-operative analgesia will be examined at intervals of 6, 12, 24, and 48 h.
STATISTICAL ANALYSIS
Statistical analysis will be done by IBM SPSS (IBM Corp. Released 2011. IBM
SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp). Mean and
SD will be used to summarize the data. A ‘P’ value of <0.05 will be considered as
statistically significant difference.
Study Design
- Study Type
- Interventional
- Allocation
- Stratified block randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients those who will be diagnosed with symptomatic irreversible pulpitis and symptomatic apical periodontitis of mandibular molar teeth were included into the study.
- •ASA category I, II Patient age group – 20-60.
Exclusion Criteria
- •Exclusion criteria included ASA category III and above, patients with any prior medications, those allergic to LA, pregnant, and lactating women.
Outcomes
Primary Outcomes
anesthetic and post operative analgesic efficacy expected with addition of magnesium sulfate
Time Frame: anesthetic and post operative analgesic efficacy expected with addition of magnesium sulfate. The onset of anaesthesia will be evaluated by EPT for every 1 min until the | corresponding vital tooth stops responding. Lip numbness will be considered to | check the aesthetic success within 15 minutes.The duration of anaesthesia will be | evaluated every 15 min using EPT till the adjacent normal tooth responded on the | working side.
Secondary Outcomes
- post operative analgesic efficacy expected with addition of magnesium sulfate(anesthetic efficacy expected with addition of magnesium sulfate. Pain data will be collected after access cavity and insertion of files in the canals.)