Symptomatic Irreversible PulpitisPhase 4NCT04608981
Effect of Diclofenac Potassium Versus Prednisolone on Post-endodontic Pain and Pulpal IL-8 Expression
A Phase 4 study testing Prednisolone 30 mg and Diclofenac Potassium 50mg Tab in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial summary
To assess the effect of using diclofenac potassium versus prednisolone as a pre-medication compared to placebo on: Intensity of post-endodontic pain in patients with symptomatic irreversible pulpitis. Pulpal IL-8 expression. Incidence of post-endodontic pain in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Prednisolone 30 mg and 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
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Feb 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-50 years.
- Males and females.
- American Society of Anesthesiologists class 1 or 2.
- Mandibular premolar teeth with:
- Endodontic pulpal diagnosis of symptomatic irreversible pulpitis
- Normal/slight widening in the periodontal membrane space (PMS).
- Patients who had not taken any anti-inflammatory drugs the day of the root canal procedure unless they belong to one of the intervention groups.
- Patients who accept to participate in the trial, understand the VAS, and can sign the informed consent
Who cannot join
- Cases with acute peri-apical conditions (acute apical periodontitis/ acute apical abscess), pulpal necrosis, previously initiated therapy, or previously treated.
- Teeth other than single-rooted teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, or calcification.
- Immature teeth.
- Unrestorable teeth or teeth with severe periodontal disease.
- Patients with a known allergy, sensitivity, or history of other adverse reactions to the medications administered.
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- Patients with a history of active peptic ulcer within the preceding 12 months, bleeding problems, anticoagulant use within the last month, or kidney disease.
- Patients who took analgesics/ anti-inflammatory drugs (steroidal or non-steroidal) the day of endodontic treatment.
- Pregnant or nursing females.
- Patients who are unable to provide informed consent
Trial locations and contacts
No sites are listed yet.
Sara S Abouelenien, PhD contact
About this study
Official title: Effect of Diclofenac Potassium Versus Prednisolone as a Premedication on Post-endodontic Pain and Pulpal Interleukin (IL)-8 Expression in Symptomatic Irreversible Pulpitis Cases: A Randomized Clinical Trial
To assess the effect of using diclofenac potassium versus prednisolone as a pre-medication compared to placebo on:
- Intensity of post-endodontic pain in patients with symptomatic irreversible pulpitis.
- Pulpal IL-8 expression.
- Incidence of post-endodontic pain in patients with symptomatic irreversible pulpitis.
Read the detailed description
After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study.
- Patients will be asked to rate their pre-operative pain intensity (ie, before the commencement of any treatment [baseline score]; on the visual analogue scale "VAS"
- Enrolled patients will be randomly assigned into one of three groups:
Intervention Group 1 (Diclofenac Potassium): single, oral dose of 50 mg diclofenac potassium pre-medication (Cataflam; NOVARTIS Pharma, Basel, Switzerland) one hour before starting endodontic treatment.
Intervention Group 2 (Prednisolone): single, oral dose of 30 mg prednisolone (one and a half tablets Solupred oro 20 mg, ARE, Aventis Intercontinental, Paris, France) 30 min before starting endodontic treatment.
Control Group (Placebo): The patients assigned to this group will be given a placebo tablet (Starch, Bridgewater, NJ) one hour before starting endodontic treatment.
- Root canal therapy in all groups will be completed by the principal investigator in a single visit as follows:
- Anesthetizing the tooth using inferior alveolar nerve block technique by local anesthesia of 1.8 ml of 2% Mepivacaine HCl with 1:100,000 epinephrine.
- After anesthesia is achieved and verified with Endo-Ice, the patient's tooth is isolated with a rubber dam, caries is excavated, and the pulp is exposed with a sterile round bur.
- Preparation of access cavity using a sterile round carbide bur and an Endo-Z bur
- Sample Collection:
- Blood from the exposed surface of the pulp will be collected with 2 sterile cotton pellets.
- The pellets will be held at the exposure site for 45-60 seconds to allow absorption of the blood from the pulpal tissue.
- The pellets will be placed in 1.0 mL saline in heparin-coated tubes.
- Samples will be placed on ice and stored/refrigerated immediately at -20 degrees celsius until they are ready to be tested.
- After the pulpal blood sample is collected, patency of the root canals will be confirmed using stainless steel hand K-files sizes #10 and #15.
- Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex.
- Mechanical preparation will be completed in a crown down technique with ProTaper Next10 rotary files set on an endodontic motor adjusted at a speed of 300 rpm and torque of 200 gcm. In-and-out motions will be applied with stroke lengths not exceeding 3mm in the cervical, middle, and apical thirds until attaining the established WL.
- The root canal will be thoroughly irrigated with 3 mL of 2.6% sodium hypochlorite using a plastic disposable syringe with a 30-gauge side-vented needle reaching 1mm short of the working length between every subsequent instrument, whereas saline will be used as the final irrigant.
- The canal will then be dried using sterile paper points. Master cone fit radiograph will be taken and then the root canal will be obturated at the same appointment with matching-size gutta percha points and resin-based sealer using cold lateral compaction technique.
- Access cavity will be sealed with Coltosol F temporary filling material.
- At the end of the session, each patient will be instructed to complete a pain diary, (VAS), at specific intervals; immediately after treatment completion; and 6, 12, 24, and 48 hours after the completion of treatment. The patient will be asked to mark the level of pain on this 10-cm line. The distance from the left end to the mark made by the patient, which will be measured by the operator with a ruler, is the pain intensity.
- Patients will be contacted by their operator at each time-point to check on them and as a reminder. Then, information will be documented.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Prednisolone 30 mg, Diclofenac Potassium 50mg Tab, Placebo
- Keywords
- prednisolone, diclofenac potassium, interleukin-8
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone 30 mgDrug
Also called One and a half tablets Solupred oro 20 mg, ARE, Aventis Intercontinental, Paris, France
Steroidal anti-inflammatory drug as a preoperative medication
Diclofenac Potassium 50mg TabDrug
Also called Cataflam; NOVARTIS Pharma, Basel, Switzerland
Non-steroidal anti-inflammatory drug as a preoperative medication
PlaceboDrug
Starch
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone premedication | Experimental | Single, oral dose of 30 mg prednisolone pre-medication 30 min before starting endodontic treatment. Receives: Drug: Prednisolone 30 mg |
| Diclofenac potassium premedication | Experimental | Single, oral dose of 50 mg diclofenac potassium pre-medication 1 hour before starting endodontic treatment. Receives: Drug: Diclofenac Potassium 50mg Tab |
| Placebo | Placebo comparator | Placebo tablet 1 hour before starting endodontic treatment. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the intensity of post-endodontic pain
Pain intensity will be evaluated using visual analogue scale
Measured: Immediately after treatment completion; and at 6, 12, 24, and 48 hours post-operatively
Secondary outcomes (1)
Quantification of pulpal IL-8
Il-8 analasys will be done via enzyme-linked immunosorbent assay (ELISA)
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study startMar 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionFeb 2022 (estimated)
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Abdullah Ali Soliman, Cairo University
- Investigators
- Ahmed A Soliman, MSc, Principal investigator, Cairo UniversityKhaled Ezzat, PhD, Study director, Cairo UniversitySara S Abouelenien, PhD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608981
- Sponsor's protocol ID
- CairoU_IL8
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soliman AA, Ezzat KM, Shaker OG, Abouelenien SS. Influence of Diclofenac Potassium versus Prednisolone on Postendodontic Pain and Pulpal Interleukin-8 Expression in Symptomatic Irreversible Pulpitis Cases: A Randomized Placebo-controlled Trial. J Endod. 2024 Sep;50(9):1213-1220. doi: 10.1016/j.joen.2024.05.019. Epub 2024 Jun 24.
PubMed 38925367
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diclofenac Potassium Versus Prednisolone as a Premedication on Post-endodontic Pain and Pulpal Interleukin (IL)-8 Expression in Symptomatic Irreversible Pulpitis Cases: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04608981
- Acronym / sponsor ID
- CairoU_IL8
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- prednisolone, diclofenac potassium, interleukin-8
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 30 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.
To assess the effect of using diclofenac potassium versus prednisolone as a pre-medication compared to placebo on:
- Intensity of post-endodontic pain in patients with symptomatic irreversible pulpitis.
- Pulpal IL-8 expression.
- Incidence of post-endodontic pain in patients with symptomatic irreversible pulpitis.
Detailed description
After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study.
- Patients will be asked to rate their pre-operative pain intensity (ie, before the commencement of any treatment [baseline score]; on the visual analogue scale "VAS"
- Enrolled patients will be randomly assigned into one of three groups:
Intervention Group 1 (Diclofenac Potassium): single, oral dose of 50 mg diclofenac potassium pre-medication (Cataflam; NOVARTIS Pharma, Basel, Switzerland) one hour before starting endodontic treatment.
Intervention Group 2 (Prednisolone): single, oral dose of 30 mg prednisolone (one and a half tablets Solupred oro 20 mg, ARE, Aventis Intercontinental, Paris, France) 30 min before starting endodontic treatment.
Control Group (Placebo): The patients assigned to this group will be given a placebo tablet (Starch, Bridgewater, NJ) one hour before starting endodontic treatment.
- Root canal therapy in all groups will be completed by the principal investigator in a single visit as follows:
- Anesthetizing the tooth using inferior alveolar nerve block technique by local anesthesia of 1.8 ml of 2% Mepivacaine HCl with 1:100,000 epinephrine.
- After anesthesia is achieved and verified with Endo-Ice, the patient's tooth is isolated with a rubber dam, caries is excavated, and the pulp is exposed with a sterile round bur.
- Preparation of access cavity using a sterile round carbide bur and an Endo-Z bur
- Sample Collection:
- Blood from the exposed surface of the pulp will be collected with 2 sterile cotton pellets.
- The pellets will be held at the exposure site for 45-60 seconds to allow absorption of the blood from the pulpal tissue.
- The pellets will be placed in 1.0 mL saline in heparin-coated tubes.
- Samples will be placed on ice and stored/refrigerated immediately at -20 degrees celsius until they are ready to be tested.
- After the pulpal blood sample is collected, patency of the root canals will be confirmed using stainless steel hand K-files sizes #10 and #15.
- Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex.
- Mechanical preparation will be completed in a crown down technique with ProTaper Next10 rotary files set on an endodontic motor adjusted at a speed of 300 rpm and torque of 200 gcm. In-and-out motions will be applied with stroke lengths not exceeding 3mm in the cervical, middle, and apical thirds until attaining the established WL.
- The root canal will be thoroughly irrigated with 3 mL of 2.6% sodium hypochlorite using a plastic disposable syringe with a 30-gauge side-vented needle reaching 1mm short of the working length between every subsequent instrument, whereas saline will be used as the final irrigant.
- The canal will then be dried using sterile paper points. Master cone fit radiograph will be taken and then the root canal will be obturated at the same appointment with matching-size gutta percha points and resin-based sealer using cold lateral compaction technique.
- Access cavity will be sealed with Coltosol F temporary filling material.
- At the end of the session, each patient will be instructed to complete a pain diary, (VAS), at specific intervals; immediately after treatment completion; and 6, 12, 24, and 48 hours after the completion of treatment. The patient will be asked to mark the level of pain on this 10-cm line. The distance from the left end to the mark made by the patient, which will be measured by the operator with a ruler, is the pain intensity.
- Patients will be contacted by their operator at each time-point to check on them and as a reminder. Then, information will be documented.
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 |
|---|---|---|
| Prednisolone premedication | Experimental | Drug: Prednisolone 30 mgSingle, oral dose of 30 mg prednisolone pre-medication 30 min before starting endodontic treatment. |
| Diclofenac potassium premedication | Experimental | Drug: Diclofenac Potassium 50mg TabSingle, oral dose of 50 mg diclofenac potassium pre-medication 1 hour before starting endodontic treatment. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablet 1 hour before starting endodontic treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18-50 years.
- Males and females.
- American Society of Anesthesiologists class 1 or 2.
- Mandibular premolar teeth with:
- Patients who had not taken any anti-inflammatory drugs the day of the root canal procedure unless they belong to one of the intervention groups.
Key exclusion criteria (10 listed)
- Cases with acute peri-apical conditions (acute apical periodontitis/ acute apical abscess), pulpal necrosis, previously initiated therapy, or previously treated.
- Teeth other than single-rooted teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, or calcification.
- Immature teeth.
- Unrestorable teeth or teeth with severe periodontal disease.
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 |
|---|---|---|
| Prednisolone 30 mgAlso: One and a half tablets Solupred oro 20 mg, ARE, Aventis Intercontinental, Paris, FranceSteroidal anti-inflammatory drug as a preoperative medication | Drug | Prednisolone premedication |
| Diclofenac Potassium 50mg TabAlso: Cataflam; NOVARTIS Pharma, Basel, SwitzerlandNon-steroidal anti-inflammatory drug as a preoperative medication | Drug | Diclofenac potassium premedication |
| PlaceboStarch | Drug | Placebo |
Primary outcome
Change in the intensity of post-endodontic pain
Time frame: Immediately after treatment completion; and at 6, 12, 24, and 48 hours post-operatively
Pain intensity will be evaluated using visual analogue scale
1 secondary outcome
Quantification of pulpal IL-8
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 38925367Soliman AA, Ezzat KM, Shaker OG, Abouelenien SS. Influence of Diclofenac Potassium versus Prednisolone on Postendodontic Pain and Pulpal Interleukin-8 Expression in Symptomatic Irreversible Pulpitis Cases: A Randomized Placebo-controlled Trial. J Endod. 2024 Sep;50(9):1213-1220. doi: 10.1016/j.joen.2024.05.019. Epub 2024 Jun 24.
- 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.
Sara S Abouelenien, PhD contact
Ahmed A Soliman, MSc principal investigator
Cairo University
Khaled Ezzat, PhD study director
Cairo University
Sara S Abouelenien, PhD study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone 30 mg and Diclofenac Potassium 50mg Tab in people with Symptomatic Irreversible Pulpitis, 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 8 inclusion and 10 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 30 Oct 2020. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Soliman, MSc (+201006779533, aasoliman89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the intensity of post-endodontic pain (time frame: Immediately after treatment completion; and at 6, 12, 24, and 48 hours post-operatively). 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 NCT04608981, 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 30 Oct 2020.