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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.
Show all 10Show fewer
  • 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.

Ahmed A Soliman, MSc contact

+201006779533

aasoliman89@gmail.com

Sara S Abouelenien, PhD contact

+201000703203

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:
  1. 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.
  2. 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.
  3. Preparation of access cavity using a sterile round carbide bur and an Endo-Z bur
  4. 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.
  1. 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.
  2. Working length will be determined using an electronic apex locator then confirmed radiographically to be 1 mm shorter than radiographic apex.
  3. 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.
  4. 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.
  5. 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.
  6. Access cavity will be sealed with Coltosol F temporary filling material.
  7. 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.
  8. Patients will be contacted by their operator at each time-point to check on them and as a reminder. Then, information will be documented.
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 groups in NCT04608981
Study groupRoleWhat they receive
Prednisolone premedicationExperimentalSingle, oral dose of 30 mg prednisolone pre-medication 30 min before starting endodontic treatment.
Receives: Drug: Prednisolone 30 mg
Diclofenac potassium premedicationExperimentalSingle, oral dose of 50 mg diclofenac potassium pre-medication 1 hour before starting endodontic treatment.
Receives: Drug: Diclofenac Potassium 50mg Tab
PlaceboPlacebo comparatorPlacebo 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.

  1. 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)
  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.

  1. First posted30 Oct 2020
  2. Study startMar 2021 (estimated)
  3. Primary completionDec 2021 (estimated)
  4. Study completionFeb 2022 (estimated)

Resources

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)
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

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.

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