Effect of different anesthetic injections on success rate of the injections while managing a painful tooth

Completed

• Conditions: Painful Symptomatic carious exposed mandibular first or second molars

• Registration Number: CTRI/2019/04/018643
• Lead Sponsor: Faculty of Dentistry self funded

Brief Summary

**Introduction**: To achieve painless treatment in patients with a failed primaryIANB, supplementary anesthesia has been advised. Majority of the studiesevaluating intraligamentary injections have been performed on asymptomaticteeth. Very limited research has been dedicated to the evaluation of differentvariables in intraligamentary injections in patients with symptomaticirreversible pulpitis **Aim**: To evaluate the anesthetic efficacy of 2% lidocainewith 1:80 000 epinephrine vs. 2% lidocaine with 1:200 000, given asintraligamentary injections after a failed inferior alveolar nerve block (IANB),in patients with symptomatic irreversible pulpitis. **Objective :** 1.To achievepainless treatment in patients with a failed primary IANB. during theendodontic management of symptomatic mandibular first/second molar. 2. To evaluate the  heart rate during and after intraligamentaryinjections

**Methods**: This prospective, randomized, double-blind clinical trial will be carriedout Conservative Dentistry, Faculty Of Dentistry, Jamia Millia Islamia. Sixtyadult patients with symptomatic irreversible pulpits in a mandibular first orsecond molar, will  receive an initialIANB with 2% lidocaine with 1:80 000 epinephrine. Pain during the endodontictreatment will be assessed using a visual analogue scale(VAS). Patientsexperiencing pain on endodontic intervention shall be randomly allocated to oneof the two treatment groups: one group shall receive 0.6 mL/ root ofsupplementary intraligamentary injection of 2% lidocaine with 1:80 000epinephrine; while the second group shall receive 2% lidocaine with 1:200 000epinephrine. Endodontic treatment will be re-initiated. Success after primaryinjection or supplementary injection will be defined as no or mild pain (lessthan 55 mm on HP VAS) during access preparation and root canal instrumentation.Heart rate will be monitored using a finger pulse oximeter by faculty member . **Statistical analysis** : The results willbe tabulated in contingency tables. The anesthetic success rates will beanalyzed with Pearson chi-square test at 5% significance levels. The heart ratechanges will be analyzed using t-test.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-01-09
• Study Start: 2019-04-22
• Last Update Posted: 2020-07-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• a.Symptomatic carious exposed mandibular first or second molars.
• b.Positive and prolonged response to thermal sensitivity tests and electric pulp test.
• c.Vital coronal pulp on access cavity preparation.
• d.American Society of Anesthesiologists class I or II medical history.
• e.Ability to understand the use of pain scales.

Exclusion Criteria

• a.Active pain in more than 1 teeth.
• b.Teeth with fused roots.
• c.Radiographic evidence of an extra root.
• d.Large restorations with overhanging margins.
• e.Full crowns or deep periodontal pockets.
• f.Known allergy or contraindications to any content of the local anesthetic solution.
• g.History of known or suspected drug abuse.
• h.Taking any drugs which could affect the pain perception, e.g, opiods, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, nsaids.
• 23 i.Pregnant or breastfeeding patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome (endpoint) will be defined as “success or failure†which will be indicated as the ability to undertake pulp access and canal instrumentation with no or mild pain.	The primary outcome (endpoint) will be defined as “success or failure†which will be indicated as the ability to undertake pulp access and canal instrumentation with no or mild pain.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be the evaluation of heart rate.	Immediately after supplementary intraligamentary injections.

Trial Locations

Locations (1)

Faculty of Dentistry, JMI; 🇮🇳 South, DELHI, India

Faculty of Dentistry, JMI

🇮🇳South, DELHI, India

Dr Vivek Aggarwal

Principal investigator

09818188358

drvivekaggarwal@gmail.com