Use of Tramadol Intraligamentary Injections

NCT05538052 | Completed DMC

• 1 other identifier: 106
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Anesthetic success rate

  absence of any response to electric pulp testing and the ability of the clinician to perform endodontic access and root canal instrumentation with no or mild pain.

  15 minutes after the injections

Secondary Outcomes (1)

• Changes in heart rates

  Immediately after the intraligamentary injections

Study Arms (3)

2% lidocaine

ACTIVE COMPARATOR

The first group will receive intraligamentary injections of 2% lidocaine with 1: 80 000 epinephrine. The injections will be administered using a pressure-type syringe (Osung Deosy, Pearland, Tx, USA) and 30 gauge short needles (Septojet needles, Septodont).

Drug: Lidocaine Hydrochloride

2% lidocaine plus tramadol hydrochloride

EXPERIMENTAL

The second group will receive intraligamentary injections of 2% lidocaine with 1:80 000 epinephrine plus tramadol hydrochloride (50 mg, 1:1 v/v ratio). The injections will be administered using a pressure-type syringe (Osung Deosy, Pearland, Tx, USA) and 30 gauge short needles (Septojet needles, Septodont).

Drug: Tramadol hydrochloride; Drug: Lidocaine Hydrochloride

tramadol hydrochloride

EXPERIMENTAL

The second group will receive intraligamentary injections of tramadol hydrochloride (25mg/ mL). The injections will be administered using a pressure-type syringe (Osung Deosy, Pearland, Tx, USA) and 30 gauge short needles (Septojet needles, Septodont).

Drug: Tramadol hydrochloride

Interventions

Tramadol hydrochloride DRUG

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

2% lidocaine plus tramadol hydrochloride; tramadol hydrochloride

Lidocaine Hydrochloride DRUG

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

2% lidocaine; 2% lidocaine plus tramadol hydrochloride

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jamia Millia Islamia: lead

Study Sites (1)

Faculty of Dentistry, Jamia MIliia Islamia

New Delhi, 110025, India

Location

MeSH Terms

Conditions

Pulpitis

Interventions

Tramadol; Lidocaine

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Acetanilides; Anilides; Amides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Alpha-numeric codes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IN (1)