Post-operative Endodontic PainPhase 2/3NCT04124822
Effectiveness if Premedication With Single Dose Piroxicam and Prednisolone After a Single Visit Root Canal Treatment .
A Phase 2/3 study testing Piroxicam 20 mg and prednisolone 20 mg in people with Post-operative Endodontic Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain after a single visit root canal treatment for 74 hours. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Post-operative Endodontic Pain
- What is being tested?
- Piroxicam 20 mg and prednisolone 20 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2018to 15 Jul 2019
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient ages from 20-40 years(28).
- Single rooted tooth with symptomatic irreversible pulpitis.
- With no analgesic or anti-inflammatory drug taken within a week period before procedure.
Who cannot join
- Patients presenting with any systemic disease
- Patients already taking premedication for endodontic pain.
- Pregnant or lactating patients.
- Multirooted teeth.
- Teeth with Pulpal necrosis.
- Previously treated or initiated root canal treatment.
- Patient presenting with allergy due to drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Single Dose Pre Medication of Piroxicam and Prednisolone on Post Endodontic Pain After a One Visit Root Canal Treatment. Randomized Trial .
Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain after a single visit root canal treatment for 74 hours.
Read the detailed description
To evaluate effectiveness of single dose premedication with piroxicam(20mg) and prednisolone(20mg) on post endodontic pain after a single visit root canal treatment .
patient will be recalled every day for 4 days to know the pain scale using visual analogue scale .
- Conditions
- Post-operative Endodontic Pain
- Being tested
- Piroxicam 20 mg, prednisolone 20 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piroxicam 20 mgDrug
Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels
prednisolone 20 mgDrug
prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | group 1 , is no intervention group in which root canal procedure will be done without drug as ideal protocol . |
| Piroxicam | Experimental | group 2 is given Piroxicam 20 mg half an hour before root canal treatment to manage post operative pain. Receives: Drug: Piroxicam 20 mg |
| Prednisolone | Experimental | group 3 is given Prednisolone 20mg half an hour before root canal treatment to manage post operative pain. Receives: Drug: prednisolone 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
post operative pain will be measured after single visit endodontic treatment using visual analog scale with readings 1 to 10 from 24 hours till 76 hours
Measured: 76 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start30 May 2018
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative Endodontic PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- subjects are randomly placed into one of the three groups: Placebo, Piroxicam (20 mg), Prednisolone (20 mg). The drugs will be given thirty minutes before procedure starts,followed by one visit root canal procedure. Postoperative pain will be evaluated up to 96 hours interval using a visual analog scale.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anum Tanwir , MDS, Dow University of Health Sciences
- Investigators
- Anum Tanwir, BDS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124822
- Sponsor's protocol ID
- Dikiohs2013
- Status last verified
- Oct 2019
- First submitted
- 19 Aug 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanwir A, Ahmed S, Akhtar H, Wahid U, Shakoor Abbasi M, Ahmed N. Effectiveness of Single Dose Premedication of Piroxicam and Prednisolone on Post Endodontic Pain in One Visit Root Canal Treatment: A Randomized Clinical Trial. Eur Endod J. 2022 Oct;7(3):187-192. doi: 10.14744/eej.2022.24119.
PubMed 36217645
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Single Dose Pre Medication of Piroxicam and Prednisolone on Post Endodontic Pain After a One Visit Root Canal Treatment. Randomized Trial .
- ClinicalTrials.gov ID
- NCT04124822
- Acronym / sponsor ID
- Dikiohs2013
- Conditions
- Post-operative Endodontic Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 11 Oct 2019 (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.
Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain after a single visit root canal treatment for 74 hours.
Detailed description
To evaluate effectiveness of single dose premedication with piroxicam(20mg) and prednisolone(20mg) on post endodontic pain after a single visit root canal treatment .
patient will be recalled every day for 4 days to know the pain scale using visual analogue scale .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- subjects are randomly placed into one of the three groups: Placebo, Piroxicam (20 mg), Prednisolone (20 mg). The drugs will be given thirty minutes before procedure starts,followed by one visit root canal procedure. Postoperative pain will be evaluated up to 96 hours interval using a visual analog scale.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –group 1 , is no intervention group in which root canal procedure will be done without drug as ideal protocol . |
| Piroxicam | Experimental | Drug: Piroxicam 20 mggroup 2 is given Piroxicam 20 mg half an hour before root canal treatment to manage post operative pain. |
| Prednisolone | Experimental | Drug: prednisolone 20 mggroup 3 is given Prednisolone 20mg half an hour before root canal treatment to manage post operative pain. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient ages from 20-40 years(28).
- Single rooted tooth with symptomatic irreversible pulpitis.
- With no analgesic or anti-inflammatory drug taken within a week period before procedure.
Key exclusion criteria (7 listed)
- Patients presenting with any systemic disease
- Patients already taking premedication for endodontic pain.
- Pregnant or lactating patients.
- Multirooted teeth.
- Teeth with Pulpal necrosis.
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 |
|---|---|---|
| Piroxicam 20 mgPiroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels | Drug | Piroxicam |
| prednisolone 20 mgprednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain | Drug | Prednisolone |
Primary outcome
post operative pain
Time frame: 76 hours
post operative pain will be measured after single visit endodontic treatment using visual analog scale with readings 1 to 10 from 24 hours till 76 hours
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 11 Oct 2019.
- Derived from this study: PubMed 36217645Tanwir A, Ahmed S, Akhtar H, Wahid U, Shakoor Abbasi M, Ahmed N. Effectiveness of Single Dose Premedication of Piroxicam and Prednisolone on Post Endodontic Pain in One Visit Root Canal Treatment: A Randomized Clinical Trial. Eur Endod J. 2022 Oct;7(3):187-192. doi: 10.14744/eej.2022.24119.
- Individual participant dataSharing planned: No
Related trials for Post-operative Endodontic Pain
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
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Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
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.
Anum Tanwir, BDS principal investigator
Dow University of Health Sciences
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 Piroxicam 20 mg and prednisolone 20 mg in people with Post-operative Endodontic Pain, run by Dow University of Health Sciences at 1 site in Pakistan.
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 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 11 Oct 2019. 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 Pakistan. 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. 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?
post operative pain (time frame: 76 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 NCT04124822, which also lists 1 linked publication.
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 11 Oct 2019.