PulpitisNCT05538052
Use of Tramadol Intraligamentary Injections
A study testing Tramadol hydrochloride and Lidocaine Hydrochloride in people with Pulpitis, run by Jamia Millia Islamia at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- Tramadol hydrochloride and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2022to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Tramadol Injections on the Anaesthetic Success Rate of Intraligamentary Injections in Patients With Symptomatic Irreversible Pulpitis
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.
Read the detailed description
Patients experiencing a failed primary IANB shall be enrolled in the study. The initial failure will be defined as pain (score more than 54 on Heft Parker Visual Analog Scale (VAS) during access cavity preparation or at the root canal instrumentation stage. The primary outcome (endpoint) will be defined as "success or failure, " indicating the ability to undertake pulp access and canal instrumentation with no or mild pain. The secondary outcome will be the evaluation of heart rate after supplementary intraligamentary injections.
A tentative sample size calculation has been performed using data from a previous study, keeping the α level type I error at 0.05 for a single-tailed test and β level type II error at 0.20.19 The analysis indicated that a sample size of 35 subjects would give 80% power to detect a 30% difference in the success rates of the two different supplemental intraligamentary injections. For heart rate analysis, it has been calculated that a minimum of 23 patients per group shall be required to detect a difference of 10 beats per minute (with a baseline heart rate of 72 beats per minute).
The treatment procedure and the use of pain scales will be explained to the patients. A combined VAS, the Heft-Parker scale (HP VAS), will be used in the present study.
All patients will receive a primary IANB injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance will be felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over a period of 60 seconds. After 10 minutes, the patients will be asked about lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. Patients will be instructed to raise their hands if any pain will be felt during the procedure. In case of pain during treatment, the procedure will be stopped, and the patients will be asked to rate the pain on the HP VAS. The patients with failed primary IANB will receive supplementary intraligamentary injections of either 2% lidocaine with 1:80 000 epinephrine or 2% lidocaine with 1:80 000 epinephrine plus tramadol hydrochloride (50 mg, 1:1 v/v ratio) or tramadol hydrochloride (25mg/mL). The cartridges will be masked with an opaque tape and coded with an alpha-numeric code. The code will be broken only after the completion of the study. The patients will be randomly allocated to three treatment groups (n=105, 35 patients per group) with the help of an online random generator. The rubber dam will be removed and the injection site will be cleaned with an antiseptic solution. The resting heart rate will be monitored with a finger pulse oximeter by a faculty member. 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). 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 third group shall receive intraligamentary injections of tramadol hydrochloride (25mg/ mL). A total of 1.2 mL of anaesthetic solution will be deposited. The heart rate will be measured at 15-second intervals till 5 minutes after intraligamentary injections. Success will be again defined as no pain or faint/weak/mild pain during endodontic access preparation and instrumentation.
Statistical analysis: The results will be tabulated in contingency tables. The age of patients will be analyzed using the Mann-Whitney U test at P < .05. The gender and distribution of teeth will be analyzed using 2X2 contingency tables and chi-square tests. The anaesthetic success rates will be analyzed with the Pearson chi-square test. The heart rate changes will be analyzed using a t-test.
- Conditions
- Pulpitis
- Being tested
- Tramadol hydrochloride, Lidocaine Hydrochloride
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol hydrochlorideDrug
Supplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth
Lidocaine HydrochlorideDrug
Supplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Drug: Tramadol hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes after the injections
Secondary outcomes (1)
Changes in heart rates
detection of any change in the heart rates after intraligamentary injections
Measured: Immediately after the intraligamentary injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Apr 2022
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamia Millia Islamia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vivek Aggarwal, Jamia Millia Islamia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538052
- Sponsor's protocol ID
- 106
- Status last verified
- Dec 2022
- First submitted
- 8 Sep 2022
- Last updated
- 19 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Tramadol Injections on the Anaesthetic Success Rate of Intraligamentary Injections in Patients With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05538052
- Acronym / sponsor ID
- 106
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Jamia Millia IslamiaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients experiencing a failed primary IANB shall be enrolled in the study. The initial failure will be defined as pain (score more than 54 on Heft Parker Visual Analog Scale (VAS) during access cavity preparation or at the root canal instrumentation stage. The primary outcome (endpoint) will be defined as "success or failure, " indicating the ability to undertake pulp access and canal instrumentation with no or mild pain. The secondary outcome will be the evaluation of heart rate after supplementary intraligamentary injections.
A tentative sample size calculation has been performed using data from a previous study, keeping the α level type I error at 0.05 for a single-tailed test and β level type II error at 0.20.19 The analysis indicated that a sample size of 35 subjects would give 80% power to detect a 30% difference in the success rates of the two different supplemental intraligamentary injections. For heart rate analysis, it has been calculated that a minimum of 23 patients per group shall be required to detect a difference of 10 beats per minute (with a baseline heart rate of 72 beats per minute).
The treatment procedure and the use of pain scales will be explained to the patients. A combined VAS, the Heft-Parker scale (HP VAS), will be used in the present study.
All patients will receive a primary IANB injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance will be felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over a period of 60 seconds. After 10 minutes, the patients will be asked about lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. Patients will be instructed to raise their hands if any pain will be felt during the procedure. In case of pain during treatment, the procedure will be stopped, and the patients will be asked to rate the pain on the HP VAS. The patients with failed primary IANB will receive supplementary intraligamentary injections of either 2% lidocaine with 1:80 000 epinephrine or 2% lidocaine with 1:80 000 epinephrine plus tramadol hydrochloride (50 mg, 1:1 v/v ratio) or tramadol hydrochloride (25mg/mL). The cartridges will be masked with an opaque tape and coded with an alpha-numeric code. The code will be broken only after the completion of the study. The patients will be randomly allocated to three treatment groups (n=105, 35 patients per group) with the help of an online random generator. The rubber dam will be removed and the injection site will be cleaned with an antiseptic solution. The resting heart rate will be monitored with a finger pulse oximeter by a faculty member. 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). 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 third group shall receive intraligamentary injections of tramadol hydrochloride (25mg/ mL). A total of 1.2 mL of anaesthetic solution will be deposited. The heart rate will be measured at 15-second intervals till 5 minutes after intraligamentary injections. Success will be again defined as no pain or faint/weak/mild pain during endodontic access preparation and instrumentation.
Statistical analysis: The results will be tabulated in contingency tables. The age of patients will be analyzed using the Mann-Whitney U test at P < .05. The gender and distribution of teeth will be analyzed using 2X2 contingency tables and chi-square tests. The anaesthetic success rates will be analyzed with the Pearson chi-square test. The heart rate changes will be analyzed using a t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2% lidocaine | Active comparator | Drug: Lidocaine HydrochlorideThe 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). |
| 2% lidocaine plus tramadol hydrochloride | Experimental | Drug: Tramadol hydrochloride, Drug: Lidocaine HydrochlorideThe 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). |
| tramadol hydrochloride | Experimental | Drug: Tramadol hydrochlorideThe 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol hydrochlorideSupplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth | Drug | 2% lidocaine plus tramadol hydrochloride, tramadol hydrochloride |
| Lidocaine HydrochlorideSupplementary intraligamentary injections deposited in the gingival sulcus of the involved tooth | Drug | 2% lidocaine, 2% lidocaine plus tramadol hydrochloride |
Primary outcome
Anesthetic success rate
Time frame: 15 minutes after the injections
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.
1 secondary outcome
Changes in heart rates
Time frame: Immediately after the intraligamentary injections
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tramadol hydrochloride and Lidocaine Hydrochloride in people with Pulpitis, run by Jamia Millia Islamia at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic success rate (time frame: 15 minutes after the injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2022.