A clinical trial to study the effect of a chemical on dental pain when added to regular anesthesia injection in children.

Not yet recruiting

• Conditions: Pulpitis,

• Registration Number: CTRI/2023/01/049239
• Lead Sponsor: Dr Raghuram Chilukuri

Brief Summary

This study is a prospective, split mouth, double blinded, randomized control trial to evaluate the effect of addition of 0.18ml of 2mg/kg magnesium sulphate to 2% lignocaine hydrochloride on pulpal anesthesia achieved after administration of inferior alveolar nerve block in children having irreversible pulpitis in primary mandibular second molars. Study will be done in a single center in Manipal, India with a sample size of 35 children. The primary outcome measures will be to evaluate and compare the effect of pulpal anesthesia achieved when magnesium sulphate is added to lignocaine hydrochloride local anesthesia to that of a regular lignocaine local anesthesia. Secondary outcome measures will be to measure the onset, duration of anesthesia and adverse effects on adding magnesium sulphate to lignocaine hydrochloride local anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-02
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patients in 6 years to 9 years of age group with ability to understand pain record scales With positive or definitely positive behavior as per Frankel behavior rating scale With parental consent With primary mandibular second molars showing symptoms of irreversible pulpitis having lingering response to cold test With moderate to severe pain in Heft Parker Visual Analogue scale after cold test With no radiographic alterations of periodontal ligament space and fully formed roots.

Exclusion Criteria

Patients having history of allergies to magnesium sulphate or local anesthesia or other medications Uncooperative patients Patients having history of significant medical conditions Patients taking beta blockers and opioids preoperatively Patients with primary mandibular second molars with signs of irreversible pulpitis with no pain responding normally to cold test Presence of periodontal ligament space enlargement and presence of periapical radiolucency in radiographic examination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is to evaluate and compare the effect of pulpal anesthesia achieved when inferior alveolar nerve block is given with lignocaine hydrochloride containing magnesium sulphate to that of inferior alveolar nerve block containing lignocaine hydrochloride without magnesium sulphate in treatment of irreversible pulpitis in primary mandibular second molars. Pulpal Pain levels of the patient while performing pulpectomy procedure will be assessed after intervention.	Pain levels will be assessed for a span of 1 hour while doing pulpectomy after administering nerve block.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is the onset duration and adverse affects on adding magnesium sulphate to lignocaine hydrochloride local anesthesia in inferior alveolar nerve block	24 hours

Trial Locations

Locations (1)

Manipal College of Dental sciences; 🇮🇳 Udupi, KARNATAKA, India

Manipal College of Dental sciences

🇮🇳Udupi, KARNATAKA, India

Dr Raghuram chilukuri

Principal investigator

9177477093

raghudrchilukuri@gmail.com