Non-Vital ToothNCT03998826
Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars
A study testing Piroxicam in people with Non-Vital Tooth, run by Cairo University.
Trial summary
The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Non-Vital Tooth
- What is being tested?
- Piroxicam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Dec 2020
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aging between 18-50 years old
- Patients with mandibular molar with non-vital pulp.
- Systemically- healthy patients (ASA I or II).
- Patients who agree to attend for recall appointments and provide a written consent.
Who cannot join
- Pregnant or lactating female patients.
- Patients allergic to piroxicam.
- History of peptic ulceration.
- Periapical abscess, fistula.
- Non-restorable teeth.
- Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
Trial locations and contacts
No sites are listed yet.
Suzan AW Amin, Ph.D contact
About this study
Official title: Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial
The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.
Read the detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be recorded.
- Conditions
- Non-Vital Tooth
- Being tested
- Piroxicam, Placebo
- Keywords
- Piroxicam, Postendodontic pain, analgesic intake
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiroxicamDrug
20mg piroxicam
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Piroxicam drug | Experimental | 20 mg piroxicam Receives: Drug: Piroxicam |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the first visit
Measured: 6 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the first visit
Measured: 12 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
Measured: 24 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
Measured: 48 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 72 hours after the first visit
Measured: 72 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
Measured: 7 days
Secondary outcomes (1)
Analgesic medication intake incidence
Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.
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 posted26 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Vital ToothStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Fathelrahman Mohamed, Cairo University
- Investigators
- Asmaa FE Mohamed, B.D.S, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998826
- Sponsor's protocol ID
- CEBD-CU-2019-06-13
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Konagala RK, Mandava J, Pabbati RK, Anupreeta A, Borugadda R, Ravi R. Effect of pretreatment medication on postendodontic pain: A double-blind, placebo-controlled study. J Conserv Dent. 2019 Jan-Feb;22(1):54-58. doi: 10.4103/JCD.JCD_135_18.
PubMed 30820083Joshi N, Mathew S, George JV, Hegde S, Bhandi S, Madhu KS. Comparative evaluation of the efficacy of two modes of delivery of Piroxicam (Dolonex((R))) for the management of postendodontic pain: A randomized control trial. J Conserv Dent. 2016 Jul-Aug;19(4):301-5. doi: 10.4103/0972-0707.186454.
PubMed 27563175Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.
PubMed 14606784Mohamed AF, El-Asfouri HA, Amin SAW. Effect of sublingual fast-dissolving piroxicam premedication on postoperative pain experience in mandibular molars with non-vital pulp: a randomized double-blind controlled trial. Head Face Med. 2024 Sep 21;20(1):52. doi: 10.1186/s13005-024-00453-x.
PubMed 39306665
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03998826
- Acronym / sponsor ID
- CEBD-CU-2019-06-13
- Conditions
- Non-Vital Tooth
- Keywords
- Piroxicam, Postendodontic pain, analgesic intake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Jun 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.
The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.
Detailed description
- Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
- Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
- Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be recorded.
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
- Parallel Assignment Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
| Arm | Type | Receives |
|---|---|---|
| Piroxicam drug | Experimental | Drug: Piroxicam20 mg piroxicam |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aging between 18-50 years old
- Patients with mandibular molar with non-vital pulp.
- Systemically- healthy patients (ASA I or II).
- Patients who agree to attend for recall appointments and provide a written consent.
Key exclusion criteria (6 listed)
- Pregnant or lactating female patients.
- Patients allergic to piroxicam.
- History of peptic ulceration.
- Periapical abscess, fistula.
- Non-restorable teeth.
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 |
|---|---|---|
| Piroxicam20mg piroxicam | Drug | Piroxicam drug |
| Placeboplacebo | Drug | Placebo |
Primary outcome
Postendodontic pain using a pain-measuring scale
Time frame: 6 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the first visit
Postendodontic pain using a pain-measuring scale
Time frame: 12 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the first visit
Postendodontic pain using a pain-measuring scale
Time frame: 24 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
Postendodontic pain using a pain-measuring scale
Time frame: 48 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
Postendodontic pain using a pain-measuring scale
Time frame: 72 hours
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 72 hours after the first visit
Postendodontic pain using a pain-measuring scale
Time frame: 7 days
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
1 secondary outcome
Analgesic medication intake incidence
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 30820083Konagala RK, Mandava J, Pabbati RK, Anupreeta A, Borugadda R, Ravi R. Effect of pretreatment medication on postendodontic pain: A double-blind, placebo-controlled study. J Conserv Dent. 2019 Jan-Feb;22(1):54-58. doi: 10.4103/JCD.JCD_135_18.
- Background: PubMed 27563175Joshi N, Mathew S, George JV, Hegde S, Bhandi S, Madhu KS. Comparative evaluation of the efficacy of two modes of delivery of Piroxicam (Dolonex((R))) for the management of postendodontic pain: A randomized control trial. J Conserv Dent. 2016 Jul-Aug;19(4):301-5. doi: 10.4103/0972-0707.186454.
- Background: PubMed 14606784Nekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.
- Derived from this study: PubMed 39306665Mohamed AF, El-Asfouri HA, Amin SAW. Effect of sublingual fast-dissolving piroxicam premedication on postoperative pain experience in mandibular molars with non-vital pulp: a randomized double-blind controlled trial. Head Face Med. 2024 Sep 21;20(1):52. doi: 10.1186/s13005-024-00453-x.
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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.
Suzan AW Amin, Ph.D contact
Asmaa FE Mohamed, B.D.S principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Piroxicam in people with Non-Vital Tooth, run by Cairo University.
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 4 inclusion and 6 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 16 Jul 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa FE Mhamed, B.D.S (+201273035494, logainali89@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postendodontic pain using a pain-measuring scale (time frame: 6 hours). The study lists 6 primary outcomes in all. 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 NCT03998826, which also lists 4 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 16 Jul 2019.