An Early Phase 1 interventional study of Diclofenac Potassium in Teeth With Acute Irreverseble Pulpitis, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment
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Among 10 studies testing diclofenac in Pulpitis — 3 open to participants now, 3 under way, 1 of them phase 3. Diclofenac · Pulpitis.
Among the 10 studies testing diclofenac in Pulpitis, this one is the 9th largest by planned enrollment, is the only one that started in 2024, is the only one in phase 1, and was the 7th registered.
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
Browse Pulpitis studies →3 of the 10 studies testing diclofenac in Pulpitis are open now, in 1 country. Recruiting first, the newest first:
Suez Canal University · Sites in Egypt
Ages 21–50
Cairo University
Ages 18+
By country, each count listing its studies:
Diclofenac: first FDA approval 1988 (VOLTAREN). What it is approved for, and how studies give it, is on its page →
Of the 41 Pulpitis studies recruiting now, 9 (22%) set no upper age limit and 32 (78%) stop at 75 or younger; 19 take children under 18; 24 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 4 · Phase 4 3
First in 2016; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 64 across 288 interventional studies indexed under Pulpitis.
Median enrollment 70 across the 10 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 4 most frequent:
Cairo University is the lead sponsor of 4,951 studies on the registry; 1,463 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
59 studies in Pulpitis by Cairo University: 19 open now, 19 under way, none of them phase 3. Of 22 finished, 0 (0%) have results posted.
Among the 59 studies in Pulpitis by Cairo University, this one is the 45th largest by planned enrollment of the 58 interventional ones that give a count, is one of 3 that started in 2024, is one of 4 in phase 1, reaches primary completion later than 4 of the 18 other live ones, and was the 44th registered.
Cairo University’s Pulpitis studies by the year they started, since 2012.
2 of the studies testing diclofenac in Pulpitis that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07919938Phase 3Suez Canal UniversitySubmucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars | 2027-11-15 |
| NCT07743372Cairo UniversityEffect of Preoperative Diclofenac Potassium Dose on Endodontic Pain | 2027-08 |
Add all 2 to your calendar (.ics) → With an account.
Among the 10 studies testing diclofenac in Pulpitis, from their registry updates:
Among Cairo University’s 59 in Pulpitis:
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This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.
Exclusion Criteria:
Teeth that have:
i. Periodontal involvement (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility).
ii. No possible restorability. iii.Signs of pulpal necrosis; associated sinus tract or swelling.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.4 ml diclofena potassium injection 75mg/3ml drug used as Supplemental intraligamentary injection
Drug: Diclofenac Potassium
Articaine 4% with (1:100,000 Epinephrine) local anesthetic solution will be used as intraligamentary injection,
Drug: Diclofenac Potassium
NSAID
Efficacy of local anesthesia
using Heft parker Visual Analogue scale Binary where success is defined as no pain or faint/weak /mild pain\<55 mm). if \>55 defined as failure
Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Intensity of intraoperative pain
using Heft parker Visual analogue scale score ranges from on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (\< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (\> 54 mm and \< 114 mm), Severe pain (≥ 114 mm).
Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment
Post-operative pain
using Heft parker Visual analogue scale on a 170-mm VAS line with the ends labeled "no pain" and "unbearable pain. .no pain (\< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (\> 54 mm and \< 114 mm), Severe pain (≥ 114 mm).
Time frame: 6, 12, 24 and 48 hours post-operatively
Number of needed analgesic tablets in case of intolerable pain
by counting
Time frame: Up to 2 days post operatively
No study locations are listed for this record.
Start is estimated for Aug 2024; primary completion for May 2025, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diclofenac