Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04608981 |
| Other study ID # |
CairoU_IL8 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 2021 |
| Est. completion date |
February 2022 |
Study information
| Verified date |
October 2020 |
| Source |
Cairo University |
| Contact |
Ahmed A Soliman, MSc |
| Phone |
+201006779533 |
| Email |
aasoliman89[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
5. 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.
6. Working length will be determined using an electronic apex locator then confirmed
radiographically to be 1 mm shorter than radiographic apex.
7. 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.
8. 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.
9. 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.
10. Access cavity will be sealed with Coltosol F temporary filling material.
11. 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.
12. Patients will be contacted by their operator at each time-point to check on them and as
a reminder. Then, information will be documented.
