Pulpitis - IrreversibleNCT05361291
Evaluation of the Effect of Adding Dexamethasone to 2% Lidocaine
A study testing Lidocaine Hydrochloride in people with Pulpitis - Irreversible, run by Jamia Millia Islamia at 1 site in India.
Trial summary
This randomized, double-blind clinical trial aimed at the evaluation of the effect of adding dexamethasone to 2% lidocaine, given as inferior alveolar nerve block in the endodontic management of symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- Lidocaine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2020to 25 Aug 2021
- 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 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
- active pain in a mandibular molar
- prolonged response to cold testing with an ice stick and an electric pulp tester
- vital coronal pulp on access opening and ability to understand the use of pain scales
Who cannot join
- a history of known or suspected drug abuse
- history of active peptic ulcer within the preceding 12 months
- history of bleeding problems or anticoagulant use within the last month
- known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
- patients who had taken NSAIDs within 12 h before administration of the study drugs
- patients who were pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Adding Dexamethasone to 2% Lidocaine (With and Without Epinephrine) on the Anesthetic Success Rate of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
This randomized, double-blind clinical trial aimed at the evaluation of the effect of adding dexamethasone to 2% lidocaine, given as inferior alveolar nerve block in the endodontic management of symptomatic irreversible pulpitis. One hundred and twenty four patients received one of the three IANB injections before the endodontic treatment: 2% lidocaine with 1:80 000 epinephrine; 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone; and plain 2% lidocaine mixed with 2mg dexamethasone. The anesthetia was considered successful if the patients experienced no pain or faint/weak/mild pain during root canal access preparation and instrumentation (HP VAS score <55 mm). The effect of intraligamentary injections on maximum heart rates was also recorded.
- Conditions
- Pulpitis - Irreversible
- Being tested
- Lidocaine Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
Also called dexamethasone
Inferior alveolar nerve block
| Study group | Role | What they receive |
|---|---|---|
| Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine | Active comparator | An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine Receives: Drug: Lidocaine Hydrochloride |
| Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine with 2mg dexamethasone | Experimental | An Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone Receives: Drug: Lidocaine Hydrochloride |
| Inferior Alveolar nerve block with plain 2% lidocaine mixed with 2mg dexamethasone | Experimental | An Inferior Alveolar nerve block was given with plain 2% lidocaine mixed with 2mg dexamethasone Receives: Drug: Lidocaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthtic 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
Secondary outcomes (1)
Heart Rate
The effect of injections on maximum heart rates was recorded.
Measured: After 1 minutes of initial injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start1 Feb 2020
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies 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
- 124 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
- NCT05361291
- Sponsor's protocol ID
- Dexamethasone
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- 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 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Adding Dexamethasone to 2% Lidocaine (With and Without Epinephrine) on the Anesthetic Success Rate of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT05361291
- Acronym / sponsor ID
- Dexamethasone
- Conditions
- Pulpitis - Irreversible
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Jamia Millia IslamiaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 4 May 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.
This randomized, double-blind clinical trial aimed at the evaluation of the effect of adding dexamethasone to 2% lidocaine, given as inferior alveolar nerve block in the endodontic management of symptomatic irreversible pulpitis. One hundred and twenty four patients received one of the three IANB injections before the endodontic treatment: 2% lidocaine with 1:80 000 epinephrine; 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone; and plain 2% lidocaine mixed with 2mg dexamethasone. The anesthetia was considered successful if the patients experienced no pain or faint/weak/mild pain during root canal access preparation and instrumentation (HP VAS score <55 mm). The effect of intraligamentary injections on maximum heart rates was also recorded.
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 |
|---|---|---|
| Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine | Active comparator | Drug: Lidocaine HydrochlorideAn Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine |
| Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine with 2mg dexamethasone | Experimental | Drug: Lidocaine HydrochlorideAn Inferior Alveolar nerve block was given with 2% lidocaine with 1:80 000 epinephrine mixed with 2mg dexamethasone |
| Inferior Alveolar nerve block with plain 2% lidocaine mixed with 2mg dexamethasone | Experimental | Drug: Lidocaine HydrochlorideAn Inferior Alveolar nerve block was given with plain 2% lidocaine mixed with 2mg dexamethasone |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- absence of any periapical radiolucency on radiographs, except for a widened periodontal ligament
- active pain in a mandibular molar
- prolonged response to cold testing with an ice stick and an electric pulp tester
- vital coronal pulp on access opening and ability to understand the use of pain scales
Key exclusion criteria (6 listed)
- a history of known or suspected drug abuse
- history of active peptic ulcer within the preceding 12 months
- history of bleeding problems or anticoagulant use within the last month
- known allergy, sensitivity, or contraindications to any opioid or nonopioid analgesic including aspirin or NSAIDs
- patients who had taken NSAIDs within 12 h before administration of the study drugs
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 |
|---|---|---|
| Lidocaine HydrochlorideAlso: dexamethasoneInferior alveolar nerve block | Drug | Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine, Inferior Alveolar nerve block with 2% lidocaine with 1:80 000 epinephrine with 2mg dexamethasone, Inferior Alveolar nerve block with plain 2% lidocaine mixed with 2mg dexamethasone |
Primary outcome
Anesthtic 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.
1 secondary outcome
Heart Rate
Time frame: After 1 minutes of initial injection
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 5 May 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 Lidocaine Hydrochloride in people with Pulpitis - Irreversible, 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 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 5 May 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?
Anesthtic 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 5 May 2022.