Early Phase 1 Completed N=46 Randomized Single-blind Treatment

Pain Management in Teeth With Reversible Pulpitis

Reversible Pulpitis · Ibuprofen

Source: ClinicalTrials.gov NCT07114198 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcomePrimary: Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS) — 5.05; 0.64 score on a scale

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Pain Intensity From Baseline (Pre-Operative) to Immediately During the Procedure (Day 0), Measured by the Visual Analogue Scale (VAS)	5.05; 0.64	—
SECONDARY Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS)	0.59; 0.68	—

Eligibility Criteria

Inclusion Criteria

Children with no history of systemic disease,
Demonstrated cooperative behaviour during treatment,
Parental consent obtained for study participation,
Presence of a first permanent mandibular molar with:
Clinical and radiographic diagnosis of reversible pulpitis,
Deep carious lesion extending beyond three-quarters of dentine thickness on periapical/bitewing radiographs (ICDAS score 5-6),
Positive cold test response with Endo-Ice (Hygienic Corp., Akron, OH, USA) producing short-lasting pain (subsiding within <10 seconds after stimulus removal),
No clinical signs of swelling, abscess, or sinus tract,
Absence of abnormal tooth mobility,
Restorability of the tooth.

Exclusion Criteria

Presence of primary teeth requiring treatment,
Clinical or radiographic diagnosis of irreversible pulpitis, necrotic pulp, apical lesion, swelling, abscess, or sinus tract,
Analgesic intake within the preceding 12 hours,
Known allergy to ibuprofen or local anaesthetics,
Neurological or psychiatric developmental disorders,
Presence of systemic illness,
Existing gastrointestinal disease.

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Data sourced from ClinicalTrials.gov (NCT07114198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.