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NCT07114198

Pain Management in Teeth With Reversible Pulpitis

Completed EARLY_PHASE1 Results posted Last updated 24 September 2025
What this trial tests

EARLY_PHASE1 trial testing Ibuprofen 10 mg/kg in Reversible Pulpitis in 46 participants. Completed in 15 August 2025.

Timeline
2 August 2025
Primary endpoint
11 August 2025
15 August 2025

Quick facts

Lead sponsorInonu University
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment46
Start date2 August 2025
Primary completion11 August 2025
Estimated completion15 August 2025
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Inonu University

Who can join

Adults 7 to 13, any sex, with Reversible Pulpitis or Ibuprofen. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS) Primary · Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)

Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The change will be calculated as the score immediately during the procedure (Day 0) minus the Baseline (Pre-Operative) score. Higher scores indicate worse pain.

GroupValue95% CI
Control Group5.05± 3.51
Ibuprofen Group0.64± 1.14
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS) Secondary · Pre-Operative (Baseline) and 1 days post-treatment (Day 1)

Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 1. On Day 1, participants will be contacted by phone and asked to rate their pain using the same VAS tool.

GroupValue95% CI
Control Group0.59± 1.37
Ibuprofen Group0.68± 1.39
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS) Secondary · Pre-Operative (Baseline) and 3 days post-treatment (Day 3)

Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 3. On Day 3, participants will be contacted by phone and asked to rate their pain using the same VAS tool.

GroupValue95% CI
Control Group0.14± 0.47
Ibuprofen Group0.23± 0.75
Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)Analogue Scale (VAS) Secondary · Pre-Operative (Baseline) and 7 days post-treatment (Day 7)

Pain intensity will be assessed using the Visual Analogue Scale (VAS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The Baseline (Pre-Operative) VAS score will be compared with the VAS score reported by the participant on Day 7. On Day 7, participants will be contacted by phone and asked to rate their pain using the same VAS tool.

GroupValue95% CI
Control Group0.05± 0.21
Ibuprofen Group0.09± 0.29

Sponsor's own description

Effective intraoperative pain management is vital in paediatric dentistry, especially during vital pulp therapy (VPT) for reversible pulpitis. Although NSAIDs are widely used postoperatively, their role in controlling pain during treatment is less understood. To investigate the effect of preoperative ibuprofen on pain perception and physiological stress during VPT in children.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Effect of Preoperative Ibuprofen on Pain Perception and Pulse Rate in Paediatric Patients with Deep Caries: A Randomised Controlled Trial.
    Bilmez Selen M, Kuru B. · · 2026 · PMID 41972792 · DOI 10.23804/ejpd.2026.2598

Verify or expand the search:

Other recruiting trials for Reversible Pulpitis

Currently open trials in the same condition.

Other Inonu University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07114198.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing