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Use of Tramadol Intraligamentary Injections

NCT05538052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2022-12-19

No results posted yet for this study

Summary

Introduction: To achieve painless treatment in patients with a failed primary IANB, supplementary anaesthesia has been advised. The majority of the studies evaluating intraligamentary injections have been performed on asymptomatic teeth. Very limited research has been dedicated to the evaluation of different variables in intraligamentary injections in patients with symptomatic irreversible pulpitis Aim: To evaluate the anaesthetic efficacy of 2% lidocaine with 1:80 000 epinephrine vs. 2% lidocaine with 1:80 000 epinephrine plus tramadol hydrochloride (50 mg, 1:1 v/v ratio), given as intraligamentary injections after a failed inferior alveolar nerve block (IANB), in patients with symptomatic irreversible pulpitis. Objective: 1. To achieve painless treatment in patients with a failed primary IANB. during the endodontic management of symptomatic mandibular first/second molar. 2. To evaluate the heart rate during and after intraligamentary injections Methods: This prospective, randomized, double-blind clinical trial will be carried out by Conservative Dentistry, Faculty Of Dentistry, Jamia Millia Islamia. Sixty adult patients with symptomatic irreversible pulpits in a mandibular first or second molar will receive an initial IANB with 2% lidocaine with 1:80 000 epinephrine. Pain during the endodontic treatment will be assessed using a visual analogue scale(VAS). Patients experiencing pain on endodontic intervention shall be randomly allocated to one of the two treatment groups: one group shall receive 0.6 mL/ root of supplementary intraligamentary injection of 2% lidocaine with 1:80 000 epinephrine; while the second group shall receive 2% lidocaine with 1:80 000 epinephrine plus tramadol hydrochloride (50 mg, 1:1 v/v ratio). Endodontic treatment will be re-initiated. Success after primary injection or supplementary injection will be defined as no or mild pain (less than 55 mm on HP VAS) during access preparation and root canal instrumentation. Heart rate will be monitored using a finger pulse oximeter by a faculty member. Statistical analysis: The results will be tabulated in contingency tables. The anaesthetic success rates will be analyzed with the Pearson chi-square test at 5% significance levels. The heart rate changes will be analyzed using a t-test.

Conditions

  • Pulpitis

Interventions

DRUG

Tramadol hydrochloride

Supplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth

DRUG

Lidocaine Hydrochloride

Supplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth

Sponsors & Collaborators

  • Jamia Millia Islamia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05538052 on ClinicalTrials.gov