Pain Management in Teeth With Reversible Pulpitis

Not Applicable

Recruiting

• Conditions: Reversible Pulpitis; Ibuprofen
• Interventions: Drug: Ibuprofen 10 mg/kg

• Registration Number: NCT07114198
• Lead Sponsor: Inonu University

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-07-28
• Status Verified: 2025-08
• Study Start: 2025-08-02
• Study First Submitted QC: 2025-08-03
• Primary Completion: 2025-08-11
• Study First Posted: 2025-08-11
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-12
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen group	Ibuprofen 10 mg/kg	Children in this group received a single dose of ibuprofen (10 mg/kg) orally, 40 minutes prior to vital pulp therapy. The goal was to evaluate the effect of preoperative ibuprofen on intraoperative pain and physiological stress.

Primary Outcome Measures

Name	Time	Method
Change in pain intensity measured by the Visual Analogue Scale (VAS)	Immediately during the procedure (Day 0)	Pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate more severe pain. The score will be recorded at the most sensitive moment during the dental procedure, when the bur approaches within \<1 mm of the pulp tissue.

Secondary Outcome Measures

Name	Time	Method
Change in postoperative pain intensity on Day 1, measured by the Visual Analogue Scale (VAS)	1 day post-treatment (Day 1)	Pain intensity will be self-reported by participants using the Visual Analogue Scale (VAS), ranging from 0 to 10. Higher scores indicate more pain. The pain level will be recorded at home on Day 1 post-treatment.

Trial Locations

Locations (1)

Inönü University; 🇹🇷 Malatya, Turkey