Pulpitis - IrreversiblePhase 2/3NCT03174860
Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success
A Phase 2/3 study testing Diclofenac Potassium 50mg Tab in people with Pulpitis - Irreversible and Anesthesia, Local, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulpitis - Irreversible, Anesthesia, Local
- What is being tested?
- Diclofenac Potassium 50mg Tab
- 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
- Oct 2016to Apr 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with active pain (moderate-to-severe) in mandibular molars.
- Patients with prolonged response to cold testing and electric pulp tester.
- Patient with the ability to understand and use pain scales.
- Patient with vital coronal pulp tissue on access.
- Patient who accept to enroll to the study.
Who cannot join
- Patients' allergies or any other contraindication to diclofenac potassium or articaine.
- Pregnant and lactating females.
- Patients having pain medication in the last 6 hours.
- Patient has more than one symptomatic mandibular tooth in the same quadrant.
- Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
- Patients with active peptic ulcer and gastrointestinal disorders.
- Patients with history of bleeding problems or anticoagulant use within the last month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.
Read the detailed description
This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
- Conditions
- Pulpitis - Irreversible, Anesthesia, Local
- Being tested
- Diclofenac Potassium 50mg Tab, Placebo
- Keywords
- Pulpitis, irreversible Pulpitis, Hot tooth, Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic, Local anesthesia, Articaine, Buccal infiltration
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Potassium 50mg TabDrug
Also called Cataflam 50mg
A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
PlaceboDrug
A placebo will be taken one hour before initiation of endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac Potassium 50mg tab | Experimental | Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment. Receives: Drug: Diclofenac Potassium 50mg Tab |
| Placebo | Placebo comparator | Placebo to be administered one hour before treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of articaine buccal infiltration.
Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals.
Measured: Intraoperative
Secondary outcomes (1)
Pain on injection
The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startOct 2016
- Primary completionFeb 2018
- Study completionApr 2018
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 Pulpitis - IrreversibleStudies 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
- Model description
- The patients will be randomly divided into 2 groups: Experimental group: Diclofenac Potassium (50 mg, Cataflam) to be administered one hour before treatment. Control group: Placebo to be administered one hour before treatment.
- 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, Amatallah Hussein Nasser Al-Rawhani, Cairo University
- Investigators
- Amatallah H Al-Rawhani, Postgraduate, Principal investigator, Faculty of Oral and Dental Medicine/ Cairo University.Dr. Suzan AW Amin, PhD, Study director, Faculty of Oral and Dental Medicine/ Cairo University.Shaima'a Gawdat, PhD, Study director, Faculty of Oral and Dental Medicine/ Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174860
- Sponsor's protocol ID
- CEBC-CU-2016-11-167
- Status last verified
- Jul 2018
- First submitted
- 9 May 2017
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.
PubMed 24702239Prasanna 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 21692235
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03174860
- Acronym / sponsor ID
- CEBC-CU-2016-11-167
- Conditions
- Pulpitis - Irreversible, Anesthesia, Local
- Keywords
- Pulpitis, irreversible Pulpitis, Hot tooth, Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic, Local anesthesia, Articaine, Buccal infiltration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 5 Jun 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 purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.
Detailed description
This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomly divided into 2 groups: Experimental group: Diclofenac Potassium (50 mg, Cataflam) to be administered one hour before treatment. Control group: Placebo to be administered one hour before treatment.
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Potassium 50mg tab | Experimental | Drug: Diclofenac Potassium 50mg TabDiclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to be administered one hour before treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with active pain (moderate-to-severe) in mandibular molars.
- Patients with prolonged response to cold testing and electric pulp tester.
- Patient with the ability to understand and use pain scales.
- Patient with vital coronal pulp tissue on access.
- Patient who accept to enroll to the study.
Key exclusion criteria (7 listed)
- Patients' allergies or any other contraindication to diclofenac potassium or articaine.
- Pregnant and lactating females.
- Patients having pain medication in the last 6 hours.
- Patient has more than one symptomatic mandibular tooth in the same quadrant.
- Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
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 Potassium 50mg TabAlso: Cataflam 50mgA 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment. | Drug | Diclofenac Potassium 50mg tab |
| PlaceboA placebo will be taken one hour before initiation of endodontic treatment. | Drug | Placebo |
Primary outcome
Success of articaine buccal infiltration.
Time frame: Intraoperative
Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals.
1 secondary outcome
Pain on injection
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 19 Jul 2018.
- Background: PubMed 24702239Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.
- 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.
- 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.
Amatallah H Al-Rawhani, Postgraduate principal investigator
Faculty of Oral and Dental Medicine/ Cairo University.
Dr. Suzan AW Amin, PhD study director
Faculty of Oral and Dental Medicine/ Cairo University.
Shaima'a Gawdat, PhD study director
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 50mg Tab in people with Pulpitis - Irreversible and Anesthesia, Local, 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 7 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 19 Jul 2018. 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?
Success of articaine buccal infiltration. (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 NCT03174860, 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 19 Jul 2018.