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.

This prospective, randomized, controlled clinical trial will investigate the effect of preoperative ibuprofen administration on intraoperative pain during vital pulp therapy (VPT) in pediatric patients diagnosed with reversible pulpitis. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Inonu University. Ethical approval has been obtained from the Institutional Clinical Research Ethics Committee of Inonu University (Approval No: 2024-KAEK-08; Date: 25.12.2024). Written informed consent will be obtained from the parents of all participants.

A total of 44 children aged 7 to 13 years, in good general health, with deep carious lesions in a mandibular first permanent molar and a clinical diagnosis of reversible pulpitis will be included in the study. Participants will be randomly assigned in equal numbers (n=22 per group) to the intervention and control groups using a computer-generated randomization sequence and the sealed envelope method.

Children in the intervention group will receive oral ibuprofen (10 mg/kg) 40 minutes prior to treatment. The control group will receive no preoperative medication. A single-blind study design will be employed: the clinician performing the procedures will be aware of group allocation, while the statistician responsible for data analysis will remain blinded.

All participants will receive an inferior alveolar nerve block (IANB) before the procedure. Anesthesia will be verified with a cold test, and treatment will begin only after adequate anesthesia is confirmed. All procedures will be performed by the same pediatric dentist, following a standardized clinical protocol. The specific type of VPT (protective liner, direct pulp capping, partial pulpotomy, or coronal pulpotomy) will be selected based on clinical presentation.

Intraoperative pain will be assessed using both physiological and subjective measures. Pulse rate will be continuously monitored with a fingertip pulse oximeter, with a focus on readings taken when the bur approaches within close proximity to the pulp. Subjective pain will be measured using a Visual Analogue Scale (VAS), shown to the patient at the most sensitive moment of the procedure. Postoperative VAS scores will be recorded on Days 1, 3, and 7.

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:

  1. Clinical and radiographic diagnosis of reversible pulpitis,
  2. Deep carious lesion extending beyond three-quarters of dentine thickness on periapical/bitewing radiographs (ICDAS score 5-6),
  3. Positive cold test response with Endo-Ice (Hygienic Corp., Akron, OH, USA) producing short-lasting pain (subsiding within <10 seconds after stimulus removal),
  4. No clinical signs of swelling, abscess, or sinus tract,
  5. Absence of abnormal tooth mobility,
  6. 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.

I don't want it because the work hasn't been completed yet.

All randomized participants who met the inclusion criteria and had baseline demographic data available were included in this analysis. One participant from each group was excluded due to protocol violation, leaving 22 participants per group (total n=44).

two weeks

Adverse events were monitored in all participants at risk (n=22 per group; total 44). No all-cause mortality events were observed. All-Cause Mortality, Serious Adverse Events, and Other (Non-Serious) Adverse Events were not monitored or assessed in this study; therefore, the number of participants at risk is 0.