Symptomatic Irreversible PulpitisNCT04593160
Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
A study testing Diclofenac potassium- acetaminophen combination and Diclofenac potassium in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Diclofenac potassium- acetaminophen combination and Diclofenac potassium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2022to 10 Oct 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptomatic irreversible pulpitis with/without mechanical allodynia
- Patients with moderato to severe spontaneous pain
- Mandibular molars
- Patients with the ability to understand and use the pain scale
- Patients accepting enrollment in the study
Who cannot join
- Patients allergic to any medication or material to be used in the study
- Pregnant and lactating females
- Patients taking medications affecting pain perception in the last 12 hours
- Patients having more than one symptomatic molar in the same quadrant
- Patients with contributory medical history (ASA > II)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.
Read the detailed description
Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Diclofenac potassium- acetaminophen combination, Diclofenac potassium, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac potassium- acetaminophen combinationDrug
Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
Diclofenac potassiumDrug
Preoperative single dose of diclofenac potassium(50mg)
PlaceboDrug
Preoperative single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac potassium- acetaminophen combination | Experimental | Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination Receives: Drug: Diclofenac potassium- acetaminophen combination |
| Diclofenac potassium | Experimental | Preoperative single dose of diclofenac potassium(50mg) Receives: Drug: Diclofenac potassium |
| Placebo | Placebo comparator | Preoperative single dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetic success of inferior alveolar nerve block
Will be recorded by 11 point 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" 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 (6)
Postoperative pain at 6 hours
Will be recorded by 11 point 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Measured: 6 hours
Postoperative pain at 12 hours
Will be recorded by 11 point 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Measured: 12 hours
Postoperative pain at 24 hours
represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Measured: 24 hours
Postoperative pain at 48 hours
represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Measured: 48 hours
Postoperative pain at 72 hours
represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Measured: 72 hours
Postoperative pain at 7 days
represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start2 Mar 2022
- Primary completion20 Oct 2024
- Study completion10 Oct 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sovana Tarek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593160
- Sponsor's protocol ID
- CU-ENDO-6-10-2020.
- Status last verified
- Aug 2026
- First submitted
- 13 Oct 2020
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.
PubMed 29709297Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.
PubMed 17185119Al-Rawhani AH, Gawdat SI, Wanees Amin SA. Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial. J Endod. 2020 Aug;46(8):1023-1031. doi: 10.1016/j.joen.2020.05.008. Epub 2020 May 26.
PubMed 32470370
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04593160
- Acronym / sponsor ID
- CU-ENDO-6-10-2020.
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 19 Oct 2020 (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 a single-dose of 50 mg diclofenac potassium- 1000mg acetaminophen combination compared to diclofenac potassium alone or placebo on local anesthetic success and postoperative pain in patients with symptomatic irreversible pulpitis.
Detailed description
Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of diclofenac potassium (50mg)- acetaminophen (1000mg) combination, diclofenac potassium (50mg) alone or a placebo tablet as a control. All patients will receive the assigned premedication one hour before single-visit root canal treatment. Anesthetic success of inferior alveolar nerve block will be assessed during access and instrumentation. Postoperative endodontic pain is measured at the following time points: 6,12,24,48,72h and 7 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diclofenac potassium- acetaminophen combination | Experimental | Drug: Diclofenac potassium- acetaminophen combinationPreoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination |
| Diclofenac potassium | Experimental | Drug: Diclofenac potassiumPreoperative single dose of diclofenac potassium(50mg) |
| Placebo | Placebo comparator | Drug: PlaceboPreoperative single dose of placebo |
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 with symptomatic irreversible pulpitis with/without mechanical allodynia
- Patients with moderato to severe spontaneous pain
- Mandibular molars
- Patients with the ability to understand and use the pain scale
- Patients accepting enrollment in the study
Key exclusion criteria (5 listed)
- Patients allergic to any medication or material to be used in the study
- Pregnant and lactating females
- Patients taking medications affecting pain perception in the last 12 hours
- Patients having more than one symptomatic molar in the same quadrant
- Patients with contributory medical history (ASA > II)
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- acetaminophen combinationPreoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination | Drug | Diclofenac potassium- acetaminophen combination |
| Diclofenac potassiumPreoperative single dose of diclofenac potassium(50mg) | Drug | Diclofenac potassium |
| PlaceboPreoperative single dose of placebo | Drug | Placebo |
Primary outcome
Anesthetic success of inferior alveolar nerve block
Time frame: During the treatment
Will be recorded by 11 point 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" 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.
6 secondary outcomes
Postoperative pain at 6 hours
Time frame: 6 hours
Postoperative pain at 12 hours
Time frame: 12 hours
Postoperative pain at 24 hours
Time frame: 24 hours
Postoperative pain at 48 hours
Time frame: 48 hours
Postoperative pain at 72 hours
Time frame: 72 hours
Postoperative pain at 7 days
Time frame: 7 days
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 Sep 2026.
- Background: PubMed 29709297Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.
- Background: PubMed 17185119Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.
- Background: PubMed 32470370Al-Rawhani AH, Gawdat SI, Wanees Amin SA. Effect of Diclofenac Potassium Premedication on Postendodontic Pain in Mandibular Molars with Symptomatic Irreversible Pulpitis: A Randomized Placebo-Controlled Double-Blind Trial. J Endod. 2020 Aug;46(8):1023-1031. doi: 10.1016/j.joen.2020.05.008. Epub 2020 May 26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diclofenac potassium- acetaminophen combination and Diclofenac potassium in people with Symptomatic 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 5 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 Sep 2026. 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.
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 of inferior alveolar nerve block (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 NCT04593160, 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 Sep 2026.