Symptomatic Irreversible PulpitisNCT05238727
Volume Increase Versus Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success
A study testing 1.8 ml mepivacaine hydrochloride, 3.6 ml mepivacaine hydrochloride and 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial summary
To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- 1.8 ml mepivacaine hydrochloride, 3.6 ml mepivacaine hydrochloride and 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Sep 2023
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patients in good health (ASA Class I, II).
- Age between 18-60 years old.
- Males or females.
- Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
- Patients who can understand NRS scale and sign the informed consent.
Who cannot join
- Patients who had used any type of analgesic medication during the preceding 8 hours before the treatment.
- Pregnant or nursing females.
- Patients with a contraindication for the use of mepivacaine, articaine or any used drug or material.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Volume Increase Compared to Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success in Cases With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic irreversible pulpitis.
Read the detailed description
Patients with moderate-to-severe preoperative pain related to mandibular molars with symptomatic irreversible pulpitis will be included. Patients receive 1.8 ml, 3.6 ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine BI. Anesthetic success of inferior alveolar nerve block, intraoperative pain intensity and need for supplemental anesthesia will be assessed during treatment.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- 1.8 ml mepivacaine hydrochloride, 3.6 ml mepivacaine hydrochloride, 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.8 ml mepivacaine hydrochlorideDrug
1.8 ml mepivacaine IANB
3.6 ml mepivacaine hydrochlorideDrug
3.6 ml mepivacaine IANB
1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BIDrug
1.8 ml mepivacaine IANB plus 1.8 ml articaine BI
| Study group | Role | What they receive |
|---|---|---|
| 1.8 ml mepivacaine IANB | Active comparator | Not described Receives: Drug: 1.8 ml mepivacaine hydrochloride |
| 3.6 ml mepivacaine IANB | Experimental | Not described Receives: Drug: 3.6 ml mepivacaine hydrochloride |
| 1.8 ml mepivacaine IANB plus 1.8 ml articaine BI | Experimental | Not described Receives: Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic success
Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.
Measured: During the treatment
Secondary outcomes (2)
Intraoperative pain
Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain".
Measured: During the treatment
Need for supplemental anesthesia
Whether the patient requires supplemental anesthesia or not
Measured: During the treatment
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 startMar 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Anwar Mohammed El Said Sleem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238727
- Sponsor's protocol ID
- CU-ENDO-2-2-2022.
- Status last verified
- Feb 2022
- First submitted
- 3 Feb 2022
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abazarpoor R, Parirokh M, Nakhaee N, Abbott PV. A Comparison of Different Volumes of Articaine for Inferior Alveolar Nerve Block for Molar Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2015 Sep;41(9):1408-11. doi: 10.1016/j.joen.2015.05.015. Epub 2015 Jul 3.
PubMed 26149210Aggarwal V, Singla M, Miglani S, Kohli S, Singh S. Comparative evaluation of 1.8 mL and 3.6 mL of 2% lidocaine with 1:200,000 epinephrine for inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, randomized single-blind study. J Endod. 2012 Jun;38(6):753-6. doi: 10.1016/j.joen.2012.02.003. Epub 2012 Mar 3.
PubMed 22595107Parirokh M, Satvati SA, Sharifi R, Rekabi AR, Gorjestani H, Nakhaee N, Abbott PV. Efficacy of combining a buccal infiltration with an inferior alveolar nerve block for mandibular molars with irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):468-73. doi: 10.1016/j.tripleo.2009.11.016.
PubMed 20219602
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
- Effect of Volume Increase Compared to Supplemental 4% Articaine Buccal Infiltration on Mepivacaine Inferior Alveolar Nerve Block Success in Cases With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05238727
- Acronym / sponsor ID
- CU-ENDO-2-2-2022.
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- 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.
To assess the anesthetic success of inferior alveolar nerve block (IANB), intraoperative pain intensity and need for supplemental anesthesia on administration of 1.8ml or 3.6ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine buccal infiltration (BI) in mandibular molars with symptomatic irreversible pulpitis.
Detailed description
Patients with moderate-to-severe preoperative pain related to mandibular molars with symptomatic irreversible pulpitis will be included. Patients receive 1.8 ml, 3.6 ml 2% mepivacaine IANB, or 1.8ml 2% mepivacaine IANB plus 1.8ml 4% articaine BI. Anesthetic success of inferior alveolar nerve block, intraoperative pain intensity and need for supplemental anesthesia will be assessed during treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.8 ml mepivacaine IANB | Active comparator | Drug: 1.8 ml mepivacaine hydrochloride |
| 3.6 ml mepivacaine IANB | Experimental | Drug: 3.6 ml mepivacaine hydrochloride |
| 1.8 ml mepivacaine IANB plus 1.8 ml articaine BI | Experimental | Drug: 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in good health (ASA Class I, II).
- Age between 18-60 years old.
- Males or females.
- Mandibular molar teeth diagnosed with symptomatic irreversible pulpitis.
- Patients who can understand NRS scale and sign the informed consent.
Key exclusion criteria (3 listed)
- Patients who had used any type of analgesic medication during the preceding 8 hours before the treatment.
- Pregnant or nursing females.
- Patients with a contraindication for the use of mepivacaine, articaine or any used drug or material.
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 |
|---|---|---|
| 1.8 ml mepivacaine hydrochloride1.8 ml mepivacaine IANB | Drug | 1.8 ml mepivacaine IANB |
| 3.6 ml mepivacaine hydrochloride3.6 ml mepivacaine IANB | Drug | 3.6 ml mepivacaine IANB |
| 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI1.8 ml mepivacaine IANB plus 1.8 ml articaine BI | Drug | 1.8 ml mepivacaine IANB plus 1.8 ml articaine BI |
Primary outcome
Anesthetic success
Time frame: During the treatment
Will be recorded by 11-point numerical rating scale (NRS) consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain". Success will be defined as no to mild pain.
2 secondary outcomes
Intraoperative pain
Time frame: During the treatment
Need for supplemental anesthesia
Time frame: During the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 26149210Abazarpoor R, Parirokh M, Nakhaee N, Abbott PV. A Comparison of Different Volumes of Articaine for Inferior Alveolar Nerve Block for Molar Teeth with Symptomatic Irreversible Pulpitis. J Endod. 2015 Sep;41(9):1408-11. doi: 10.1016/j.joen.2015.05.015. Epub 2015 Jul 3.
- Background: PubMed 22595107Aggarwal V, Singla M, Miglani S, Kohli S, Singh S. Comparative evaluation of 1.8 mL and 3.6 mL of 2% lidocaine with 1:200,000 epinephrine for inferior alveolar nerve block in patients with irreversible pulpitis: a prospective, randomized single-blind study. J Endod. 2012 Jun;38(6):753-6. doi: 10.1016/j.joen.2012.02.003. Epub 2012 Mar 3.
- Background: PubMed 20219602Parirokh M, Satvati SA, Sharifi R, Rekabi AR, Gorjestani H, Nakhaee N, Abbott PV. Efficacy of combining a buccal infiltration with an inferior alveolar nerve block for mandibular molars with irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Mar;109(3):468-73. doi: 10.1016/j.tripleo.2009.11.016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing 1.8 ml mepivacaine hydrochloride, 3.6 ml mepivacaine hydrochloride and 1.8 ml mepivacaine hydrochloride IANB plus 1.8 ml articaine hydrochloride BI in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
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 3 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reham Anwar Sleem (00201014110666, reham.anwar@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetic success (time frame: During the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05238727, which also lists 3 linked publications.
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.