Irreversible PulpitisPhase 2/3NCT03749408
Effect of Addition of Mannitol to Bupivacaine on IANB Success and Post-endodontic Pain
A Phase 2/3 study testing bupivacaine plus mannitol and bupivacaine alone in people with Irreversible Pulpitis, run by Cairo University.
Trial summary
Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars. Read more about this study
- Who is it for?
- Ages 17 to 35 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- bupivacaine plus mannitol and bupivacaine alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Jun 2014
- Phase
- Phase 2/3
- 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 17 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients; age between 17-35 years old.
- Males or Females.
- Medically-free patients
- Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
- Positive patients' acceptance for participation in the study.
Who cannot join
- Patients who had any analgesic during proceeding 12 hours before the treatment.
- Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess).
- Pregnant females.
- Patients with history of significant medical conditions (contraindication of mannitol use).
- Addiction
- Psycological disturbance.
About this study
Official title: Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: A Randomized Clinical Trial
Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.
Read the detailed description
Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.
- Conditions
- Irreversible Pulpitis
- Being tested
- bupivacaine plus mannitol, bupivacaine alone
- Keywords
- inferior alveolar nerve block, long-acting local anesthesia, bupivacaine, mannitol, symptomatic irreversible pulpitits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine plus mannitolDrug
Also called vivacaine plus mannitol
local anesthesia
bupivacaine aloneDrug
Also called vivacaine
local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine plus mannitol | Active comparator | 0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol Receives: Drug: bupivacaine plus mannitol |
| bupivacaine alone | Experimental | 0.5% bupivacaine with 1:200,000epinephrine alone Receives: Drug: bupivacaine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Measured: 6 hours
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Measured: 12 hours
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Measured: 24 hours
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Measured: 48 hours
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Measured: 72 hours
Secondary outcomes (3)
Anesthetic success
yes or no
Measured: 1 hour
lip numbness duration
recorded in hours
Measured: 24 hours
Medication intake
yes or no
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safeya AbdelRahaman Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749408
- Sponsor's protocol ID
- CEBD-CU-2012-12-24
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03749408
- Acronym / sponsor ID
- CEBD-CU-2012-12-24
- Conditions
- Irreversible Pulpitis
- Keywords
- inferior alveolar nerve block, long-acting local anesthesia, bupivacaine, mannitol, symptomatic irreversible pulpitits
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Nov 2018 (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.
Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.
Detailed description
Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine plus mannitol | Active comparator | Drug: bupivacaine plus mannitol0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol |
| bupivacaine alone | Experimental | Drug: bupivacaine alone0.5% bupivacaine with 1:200,000epinephrine alone |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adult patients; age between 17-35 years old.
- Males or Females.
- Medically-free patients
- Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
- Positive patients' acceptance for participation in the study.
Key exclusion criteria (6 listed)
- Patients who had any analgesic during proceeding 12 hours before the treatment.
- Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess).
- Pregnant females.
- Patients with history of significant medical conditions (contraindication of mannitol use).
- Addiction
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 |
|---|---|---|
| bupivacaine plus mannitolAlso: vivacaine plus mannitollocal anesthesia | Drug | bupivacaine plus mannitol |
| bupivacaine aloneAlso: vivacainelocal anesthesia | Drug | bupivacaine alone |
Primary outcome
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
Time frame: 6 hours
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
Time frame: 12 hours
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
Time frame: 24 hours
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
Time frame: 48 hours
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
Time frame: 72 hours
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
3 secondary outcomes
Anesthetic success
Time frame: 1 hour
lip numbness duration
Time frame: 24 hours
Medication intake
Time frame: 72 hours
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 23 Nov 2018.
- 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 Phase 2/3 study testing bupivacaine plus mannitol and bupivacaine alone in people with 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 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 23 Nov 2018. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain (time frame: 6 hours). The study lists 5 primary outcomes in all. 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 23 Nov 2018.