Irreversible PulpitisPhase 2/3NCT03146481
Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis
A Phase 2/3 study testing Aceclofenac in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Aceclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Jul 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in good health (American Society of Anesthesiologists Class I or Class II).
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age is 18 years or older.
- Patients who can understand Heft- Parker Visual Analogue Scales.
- Patients able to sign informed consent.
Who cannot join
- Patients allergic to aceclofenac or Mepivacaine.
- Pregnant or nursing women.
- Patients having active pain in more than one molar in the same quadrant.
- Administration of analgesics within 12 h before the administration of the study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-operative Aceclofenac on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
Read the detailed description
- The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered.
- During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
- Conditions
- Irreversible Pulpitis
- Being tested
- Aceclofenac, Placebo
- Keywords
- Anesthetic efficacy, Irriversible pulpitis, Aceclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AceclofenacDrug
Also called Bristaflam
Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
PlaceboOther
Placebo tablet given one hour before starting the root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| Aceclofenac | Experimental | Aceclofenac 100 mg tablet Receives: Drug: Aceclofenac |
| placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic success
Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation which will be measured with Heft-parker VAS in which no or mild pain will be considered as anesthetic success and moderate or severe pain will be considered as anesthetic failure.
Measured: intraoperative
Secondary outcomes (1)
Pain on injection of inial IANB
Pain on injection of inial IANB will be measured with Heft-Parker VAS
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startJul 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen AwadAllah Abbas Ibrahim, Cairo University
- Investigators
- Nermeen A Abbas, Postgraduate, Principal investigator, Cairo UniversitySuzan AW Amin, PhD, Study director, Cairo UniversityShaimaa Gawdat, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146481
- Sponsor's protocol ID
- CEBD-CU-2015-5-145
- Status last verified
- Nov 2017
- First submitted
- 7 May 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ramachandran A, Khan SI, Mohanavelu D, Kumar KS. The efficacy of pre-operative oral medication of paracetamol, ibuprofen, and aceclofenac on the success of maxillary infiltration anesthesia in patients with irreversible pulpitis: A double-blind, randomized controlled clinical trial. J Conserv Dent. 2012 Oct;15(4):310-4. doi: 10.4103/0972-0707.101881.
PubMed 23112474Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.
PubMed 23716973
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Aceclofenac on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03146481
- Acronym / sponsor ID
- CEBD-CU-2015-5-145
- Conditions
- Irreversible Pulpitis
- Keywords
- Anesthetic efficacy, Irriversible pulpitis, Aceclofenac
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 May 2017 (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.
The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
Detailed description
- The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered.
- During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aceclofenac | Experimental | Drug: AceclofenacAceclofenac 100 mg tablet |
| placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients in good health (American Society of Anesthesiologists Class I or Class II).
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars
- Age is 18 years or older.
- Patients who can understand Heft- Parker Visual Analogue Scales.
- Patients able to sign informed consent.
Key exclusion criteria (4 listed)
- Patients allergic to aceclofenac or Mepivacaine.
- Pregnant or nursing women.
- Patients having active pain in more than one molar in the same quadrant.
- Administration of analgesics within 12 h before the administration of the study drug.
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 |
|---|---|---|
| AceclofenacAlso: BristaflamAceclofenac 100 mg tablet given one hour before starting the root canal treatment | Drug | Aceclofenac |
| PlaceboPlacebo tablet given one hour before starting the root canal treatment | Other | placebo |
Primary outcome
Anesthetic success
Time frame: intraoperative
Success of mandibular inferior alveolar nerve block anesthesia during access cavity preparation and instrumentation which will be measured with Heft-parker VAS in which no or mild pain will be considered as anesthetic success and moderate or severe pain will be considered as anesthetic failure.
1 secondary outcome
Pain on injection of inial IANB
Time frame: intraoperative
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 7 Nov 2017.
- Background: PubMed 23112474Ramachandran A, Khan SI, Mohanavelu D, Kumar KS. The efficacy of pre-operative oral medication of paracetamol, ibuprofen, and aceclofenac on the success of maxillary infiltration anesthesia in patients with irreversible pulpitis: A double-blind, randomized controlled clinical trial. J Conserv Dent. 2012 Oct;15(4):310-4. doi: 10.4103/0972-0707.101881.
- Background: PubMed 23716973Jena A, Shashirekha G. Effect of preoperative medications on the efficacy of inferior alveolar nerve block in patients with irreversible pulpitis: A placebo-controlled clinical study. J Conserv Dent. 2013 Mar;16(2):171-4. doi: 10.4103/0972-0707.108209.
- 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.
Nermeen A Abbas, Postgraduate principal investigator
Cairo University
Suzan AW Amin, PhD study director
Cairo University
Shaimaa Gawdat, PhD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Aceclofenac in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
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 4 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 7 Nov 2017. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Anesthetic success (time frame: intraoperative). 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 NCT03146481, which also lists 2 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 7 Nov 2017.