Irreversible PulpitisPhase 2/3NCT03163420
Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis
A Phase 2/3 study testing Diclofenac potassium in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Diclofenac potassium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients in good health as determined by a medical history and oral questioning. (ASA I or II)
- Age range is between 18 and 50 years.
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
- Patients who can understand Heft Parker Visual Analogue Scales VAS.
- Patients accepting to participate in the study and able to sign informed consent.
Who cannot join
- Pregnant female patient.
- Patients allergic to diclofenac potassium or mepivacaine.
- Patients having active pain in more than one mandibular molar.
- Patients who had taken analgesics in the 12 hours preceding the injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pre-operative Diclofenac Potassium on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Cases With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.
Read the detailed description
Objective: The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.
Design: Randomized double-blind controlled trial.
Setting and conduct:
- Patients source: Out patients of the clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 50 mg diclofenac potassium packet) and the control group (taking a placebo packet). Each packet will be taken 30 minutes before starting treatment. The patient's pain will be assessed before local anesthetic administration using Heft- Parker Visual Analog Scale (HP- VAS). . After 15 minutes of the initial inferior alveolar nerve block (IANB) of 1.8 ml of 2% mepivacaine hydrochloride with 1:100000 epinephrine, the teeth will be examined using a cold pulp sensitivity test; in case of lip numbness together with no or mild pain on cold, the treatment will be initiated.
- During root canal treatment, no to mild pain response on HP- VAS will be considered success. In case of failure, supplemental anesthesia will be administered.
- Main outcome measures: Anesthetic success during root canal treatment using HP VAS.
- Conditions
- Irreversible Pulpitis
- Being tested
- Diclofenac potassium, Placebo
- Keywords
- Anesthetic efficacy, Diclofenac, Irreversible pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac potassiumDrug
Also called Catafast-Novartis International AG, Basel, Switzerland
Diclofenac potassium 50 mg granules for oral solution
PlaceboOther
Fructose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Other: Placebo |
| Diclofenac potassium | Experimental | Diclofenac potassium 50 mg Receives: Drug: Diclofenac potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthetic success
Pain during treatment is measured using Heft Parker VAS
Measured: Intraoperative
Secondary outcomes (1)
Pain on injection of initial IANB
measured using 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 posted23 May 2017
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (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 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Youssef, Cairo University
- Investigators
- Khaled M Ezzat, Professor, Study director, Faculty of Oral and Dental medicine, Cairo UniversitySuzan AW Amin, PhD, Study chair, Faculty of Oral and Dental medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163420
- Sponsor's protocol ID
- CEBC-CU-2016-10-149
- Status last verified
- Oct 2016
- First submitted
- 15 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
PubMed 21692235Shetkar P, Jadhav GR, Mittal P, Surapaneni S, Kalra D, Sakri M, Basavaprabhu A. Comparative evaluation of effect of preoperative alprazolam and diclofenac potassium on the success of inferior alveolar, Vazirani-Akinosi, and Gow-Gates techniques for teeth with irreversible pulpitis: Randomized controlled trial. J Conserv Dent. 2016 Sep-Oct;19(5):390-5. doi: 10.4103/0972-0707.190013.
PubMed 27656053Saha SG, Jain S, Dubey S, Kala S, Misuriya A, Kataria D. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. J Clin Diagn Res. 2016 Feb;10(2):ZC25-9. doi: 10.7860/JCDR/2016/16873.7195. Epub 2016 Feb 1.
PubMed 27042580
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Diclofenac Potassium on the Anesthetic Efficacy of Inferior Alveolar Nerve Block in Cases With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03163420
- Acronym / sponsor ID
- CEBC-CU-2016-10-149
- Conditions
- Irreversible Pulpitis
- Keywords
- Anesthetic efficacy, Diclofenac, Irreversible pulpitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 23 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 clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.
Detailed description
Objective: The aim of this clinical trial is to evaluate the effect of pre-operative administration of diclofenac potassium on the efficacy of inferior alveolar nerve block on using 2% mepivacaine anaesthetic agent in patients with symptomatic irreversible pulpitis.
Design: Randomized double-blind controlled trial.
Setting and conduct:
- Patients source: Out patients of the clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
- Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (taking a 50 mg diclofenac potassium packet) and the control group (taking a placebo packet). Each packet will be taken 30 minutes before starting treatment. The patient's pain will be assessed before local anesthetic administration using Heft- Parker Visual Analog Scale (HP- VAS). . After 15 minutes of the initial inferior alveolar nerve block (IANB) of 1.8 ml of 2% mepivacaine hydrochloride with 1:100000 epinephrine, the teeth will be examined using a cold pulp sensitivity test; in case of lip numbness together with no or mild pain on cold, the treatment will be initiated.
- During root canal treatment, no to mild pain response on HP- VAS will be considered success. In case of failure, supplemental anesthesia will be administered.
- Main outcome measures: Anesthetic success during root canal treatment using HP VAS.
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 |
|---|---|---|
| Placebo | Placebo comparator | Other: Placeboplacebo |
| Diclofenac potassium | Experimental | Drug: Diclofenac potassiumDiclofenac potassium 50 mg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in good health as determined by a medical history and oral questioning. (ASA I or II)
- Age range is between 18 and 50 years.
- Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
- Patients who can understand Heft Parker Visual Analogue Scales VAS.
- Patients accepting to participate in the study and able to sign informed consent.
Key exclusion criteria (4 listed)
- Pregnant female patient.
- Patients allergic to diclofenac potassium or mepivacaine.
- Patients having active pain in more than one mandibular molar.
- Patients who had taken analgesics in the 12 hours preceding the injection.
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 |
|---|---|---|
| Diclofenac potassiumAlso: Catafast-Novartis International AG, Basel, SwitzerlandDiclofenac potassium 50 mg granules for oral solution | Drug | Diclofenac potassium |
| PlaceboFructose | Other | Placebo |
Primary outcome
anesthetic success
Time frame: Intraoperative
Pain during treatment is measured using Heft Parker VAS
1 secondary outcome
Pain on injection of initial IANB
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Background: PubMed 21692235Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x.
- Background: PubMed 27656053Shetkar P, Jadhav GR, Mittal P, Surapaneni S, Kalra D, Sakri M, Basavaprabhu A. Comparative evaluation of effect of preoperative alprazolam and diclofenac potassium on the success of inferior alveolar, Vazirani-Akinosi, and Gow-Gates techniques for teeth with irreversible pulpitis: Randomized controlled trial. J Conserv Dent. 2016 Sep-Oct;19(5):390-5. doi: 10.4103/0972-0707.190013.
- Background: PubMed 27042580Saha SG, Jain S, Dubey S, Kala S, Misuriya A, Kataria D. Effect of Oral Premedication on the Efficacy of Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. J Clin Diagn Res. 2016 Feb;10(2):ZC25-9. doi: 10.7860/JCDR/2016/16873.7195. Epub 2016 Feb 1.
- 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.
Khaled M Ezzat, Professor study director
Faculty of Oral and Dental medicine, Cairo University
Suzan AW Amin, PhD study chair
Faculty of Oral and Dental medicine, 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 Diclofenac potassium 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: status not confirmed, as of the sponsor's last update on 23 May 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?
Results are not available in the source record.
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 NCT03163420, 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 23 May 2017; AzTrials last refreshed its copy on 3 Nov 2026.