Irreversible Pulpitis With Apical PeriodontitisPhase 4NCT07281807
Comparison of the Pain Levels of Single-Dose Premedication With Piroxicam and Prednisolone on Post-Endodontic Pain in Single-Visit Root Canal Treatment of Premolars
A Phase 4 study testing Group B: patients will be given prednisolone 20mg as premedication and piroxicam 20mg in people with Irreversible Pulpitis With Apical Periodontitis and Symptomatic Apical Periodontitis, run by RANA AHMAD.
Trial summary
To compare the post operative mean pain scores by administering single-dose preoperative piroxicam and prednisolone in patients of irreversible pulpitis with symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis With Apical Periodontitis, Symptomatic Apical Periodontitis
- What is being tested?
- Group B: patients will be given prednisolone 20mg as premedication and piroxicam 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patient ranging between 18-40 years
- Having at least one premolar with diagnosis of symptomatic irreversible pulpitis according to history, examination and radiographs.
- Teeth having mature apex confirmed by periapical radiographs.
Who cannot join
- History of systemic disorders including HIV, Hepatitis
- Pregnancy (As per Medical record/ Verbally)
- Patient using medication such as analgesics or anti-inflammatory drugs
- Patient allergic to lignocaine, piroxicam and prednisolone
- Tooth not suitable for restoration
- Periodontal probing depth ≥ 4mm
- Retreatment cases
- Patients having calcified canals assessed by radiographic findings
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To compare the post operative mean pain scores by administering single-dose preoperative piroxicam and prednisolone in patients of irreversible pulpitis with symptomatic apical periodontitis.
- Being tested
- Group B: patients will be given prednisolone 20mg as premedication, piroxicam 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group B: patients will be given prednisolone 20mg as premedicationDrug
Group B: patients will be given prednisolone 20mg as premedication
piroxicam 20mgDrug
Group A: patients will be given piroxicam 20mg as premedication
| Study group | Role | What they receive |
|---|---|---|
| Group A: piroxicam | Experimental | Group A: patients will be given piroxicam 20mg as premedication Receives: Drug: piroxicam 20mg |
| Group B: prednisolone | Active comparator | Group B: patients will be given prednisolone 20mg as premedication Receives: Drug: Group B: patients will be given prednisolone 20mg as premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain after single visit root canal treatment
pain score on visual analogue scale
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
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 Pulpitis With Apical PeriodontitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RANA AHMAD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, RANA AHMAD, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281807
- Sponsor's protocol ID
- TUF/IRB/28/2025
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vatankhah M, Zargar N, Naseri M, Salem S, Baghban AA, Etemadi A, Dianat O. Analgesic Efficacy of Ibuprofen and Diclofenac Potassium on Postoperative Endodontic Pain in Maxillary and Mandibular First Molars with Irreversible Pulpitis: A Randomised Controlled Trial. Eur Endod J. 2023 Mar;8(2):133-139. doi: 10.14744/eej.2022.45238.
PubMed 37010198Benkhalil AM, Rmdan GA. Effect of Prednisolone Premedication on Postoperative Pain after Single Visit Endodontic Therapy: A Randomized Controlled Trial. Sch J App Med Sci. 2022;8:1219-26.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Pain Levels of Single-Dose Premedication With Piroxicam and Prednisolone on Post-Endodontic Pain in Single-Visit Root Canal Treatment of Premolars
- ClinicalTrials.gov ID
- NCT07281807
- Acronym / sponsor ID
- TUF/IRB/28/2025
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RANA AHMADUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 15 Dec 2025 (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.
To compare the post operative mean pain scores by administering single-dose preoperative piroxicam and prednisolone in patients of irreversible pulpitis with symptomatic apical periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: piroxicam | Experimental | Drug: piroxicam 20mgGroup A: patients will be given piroxicam 20mg as premedication |
| Group B: prednisolone | Active comparator | Drug: Group B: patients will be given prednisolone 20mg as premedicationGroup B: patients will be given prednisolone 20mg as premedication |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy patient ranging between 18-40 years
- Having at least one premolar with diagnosis of symptomatic irreversible pulpitis according to history, examination and radiographs.
- Teeth having mature apex confirmed by periapical radiographs.
Key exclusion criteria (8 listed)
- History of systemic disorders including HIV, Hepatitis
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 |
|---|---|---|
| Group B: patients will be given prednisolone 20mg as premedicationGroup B: patients will be given prednisolone 20mg as premedication | Drug | Group B: prednisolone |
| piroxicam 20mgGroup A: patients will be given piroxicam 20mg as premedication | Drug | Group A: piroxicam |
Primary outcome
pain after single visit root canal treatment
Time frame: 48 hours
pain score on visual analogue scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Results publication: PubMed 37010198Vatankhah M, Zargar N, Naseri M, Salem S, Baghban AA, Etemadi A, Dianat O. Analgesic Efficacy of Ibuprofen and Diclofenac Potassium on Postoperative Endodontic Pain in Maxillary and Mandibular First Molars with Irreversible Pulpitis: A Randomised Controlled Trial. Eur Endod J. 2023 Mar;8(2):133-139. doi: 10.14744/eej.2022.45238.
- Results publicationBenkhalil AM, Rmdan GA. Effect of Prednisolone Premedication on Postoperative Pain after Single Visit Endodontic Therapy: A Randomized Controlled Trial. Sch J App Med Sci. 2022;8:1219-26.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group B: patients will be given prednisolone 20mg as premedication and piroxicam 20mg in people with Irreversible Pulpitis With Apical Periodontitis and Symptomatic Apical Periodontitis, run by RANA AHMAD.
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 3 inclusion and 8 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: opening soon, as of the sponsor's last update on 15 Dec 2025. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rana ahmad, B.D.S., F.C.P.S. (+923335990799, ranam_ahmad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain after single visit root canal treatment (time frame: 48 hours). 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 NCT07281807, 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 15 Dec 2025.