PulpitisNCT05239078
Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
A study testing local anaesthetic injection in people with Pulpitis, run by Dr. Vivek Aggarwal.
Trial summary
Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- local anaesthetic injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 28 Feb 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- active pain in a mandibular molar
- prolonged response to cold testing with an ice stick and an electric pulp tester
- absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
- vital coronal pulp on access opening and ability to understand the use of pain scales
Who cannot join
- known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
- history of active peptic ulcer within the preceding 12 months
- history of bleeding problems or anticoagulant use within the last month
- patients who were pregnant or breast-feeding
- a history of known or suspected drug abuse
- patients who had taken NSAIDs within 12 h before administration of the study drugs
About this study
Official title: Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Study
Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.
- Conditions
- Pulpitis
- Being tested
- local anaesthetic injection
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthetic injectionDrug
Inferior alveolar nerve block
| Study group | Role | What they receive |
|---|---|---|
| Inferior Alveolar nerve block with 2% lidocaine with epinephrine | Active comparator | An inferior alveolar nerve block was given with 2% lidocaine with epinephrine Receives: Drug: local anaesthetic injection |
| Inferior Alveolar nerve block with 4% articaine with epinephrine | Experimental | An inferior alveolar nerve block was given with 4% articaine with epinephrine Receives: Drug: local anaesthetic injection |
| Inferior Alveolar nerve block with 3% plain mepivacaine | Experimental | An inferior alveolar nerve block was given with 3% plain mepivacaine Receives: Drug: local anaesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic Success
Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.
Measured: 15 minutes after the inferior alveolar nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Mar 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Vivek Aggarwal
- Sponsor type
- University, hospital or other
- Collaborators
- SGT DENTAL COLLEGE
- Responsible party
- Sponsor-investigator, Dr. Vivek Aggarwal, Jamia Millia Islamia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239078
- Sponsor's protocol ID
- SGTTHESIS
- Status last verified
- Feb 2022
- First submitted
- 24 Jan 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Pulpal Anaesthetic Efficacy of Different Anaesthetic Solutions for Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT05239078
- Acronym / sponsor ID
- SGTTHESIS
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dr. Vivek AggarwalUniversity, hospital or other
- Collaborators
- SGT DENTAL COLLEGE
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 14 Feb 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.
Pulpal and periapical inflammation and infection can cause tissue pH in the affected region to be lowered which results in less penetration of anesthetic solution in the nerve membrane and hence delays the onset of anesthesia. So, the purpose of this study was to compare the pulpal anesthetic efficacy of lidocaine, articaine, mepivacaine for inferior alveolar nerve block (IANB) in patients with irreversible pulpitis (IP). One hundred and twenty adult patients with IP concerning mandibular molars randomly received IANB with either of the three solutions: 2% lidocaine with epinephrine; 4% articaine with epinephrine; 3% plain mepivacaine. Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Endodontic treatment was initiated. Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation. The anesthetic success rates were analyzed with the chi-square test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inferior Alveolar nerve block with 2% lidocaine with epinephrine | Active comparator | Drug: local anaesthetic injectionAn inferior alveolar nerve block was given with 2% lidocaine with epinephrine |
| Inferior Alveolar nerve block with 4% articaine with epinephrine | Experimental | Drug: local anaesthetic injectionAn inferior alveolar nerve block was given with 4% articaine with epinephrine |
| Inferior Alveolar nerve block with 3% plain mepivacaine | Experimental | Drug: local anaesthetic injectionAn inferior alveolar nerve block was given with 3% plain mepivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- active pain in a mandibular molar
- prolonged response to cold testing with an ice stick and an electric pulp tester
- absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
- vital coronal pulp on access opening and ability to understand the use of pain scales
Key exclusion criteria (6 listed)
- known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
- history of active peptic ulcer within the preceding 12 months
- history of bleeding problems or anticoagulant use within the last month
- patients who were pregnant or breast-feeding
- a history of known or suspected drug abuse
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 |
|---|---|---|
| local anaesthetic injectionInferior alveolar nerve block | Drug | Inferior Alveolar nerve block with 2% lidocaine with epinephrine, Inferior Alveolar nerve block with 3% plain mepivacaine, Inferior Alveolar nerve block with 4% articaine with epinephrine |
Primary outcome
Anesthetic Success
Time frame: 15 minutes after the inferior alveolar nerve block
Pain during the endodontic treatment was assessed using a visual analog scale (Heft-Parker VAS). Success was defined as no or mild pain (pain score≤54mm on Hp VAS) during access preparation and root canal instrumentation.
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 14 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing local anaesthetic injection in people with Pulpitis, run by Dr. Vivek Aggarwal.
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 4 inclusion and 6 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 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 15 minutes after the inferior alveolar nerve block). 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 14 Feb 2022.