Pain Management in Teeth With Reversible Pulpitis

NCT07114198 | Completed Early Phase 1 Results

• 1 other identifier: Ethics number:2024-KAEK-08
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Reversible Pulpitis; Ibuprofen

Keywords

reversible pulpitis; ibuprofen; dental pain

Outcome Measures

Primary Outcomes (1)

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

  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.

  Pre-Operative (Baseline) and Immediately During the Procedure (Day 0)

Secondary Outcomes (1)

• Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 1, Measured by the Visual Analogue Scale (VAS)

  Pre-Operative (Baseline) and 1 days post-treatment (Day 1)

Other Outcomes (2)

• Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)

  Pre-Operative (Baseline) and 3 days post-treatment (Day 3)

• Change in Postoperative Pain Intensity From Baseline (Pre-Operative) to Day 7, Measured by the Visual Analogue Scale (VAS)Analogue Scale (VAS)

  Pre-Operative (Baseline) and 7 days post-treatment (Day 7)

Study Arms (2)

control group

NO INTERVENTION

Children in this group received no preoperative medication before undergoing vital pulp therapy. Standard local anesthesia was administered prior to the procedure.

ibuprofen group

EXPERIMENTAL

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.

Drug: Ibuprofen 10 mg/kg

Interventions

Ibuprofen 10 mg/kg DRUG

Ibuprofen was administered orally at a dose of 10 mg/kg body weight, 40 minutes before the start of the dental procedure. This intervention was designed to reduce intraoperative pain and pulse elevation associated with reversible pulpitis.

ibuprofen group

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inönü University

Malatya, 44050, Turkey (Türkiye)

Location

Related Publications (4)

• Carrasco-Labra A, Polk DE, Urquhart O, Aghaloo T, Claytor JW Jr, Dhar V, Dionne RA, Espinoza L, Gordon SM, Hersh EV, Law AS, Li BS, Schwartz PJ, Suda KJ, Turturro MA, Wright ML, Dawson T, Miroshnychenko A, Pahlke S, Pilcher L, Shirey M, Tampi M, Moore PA. Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in children: A report from the American Dental Association Science and Research Institute, the University of Pittsburgh School of Dental Medicine, and the Center for Integrative Global Oral Health at the University of Pennsylvania. J Am Dent Assoc. 2023 Sep;154(9):814-825.e2. doi: 10.1016/j.adaj.2023.06.014.

  PMID: 37634915 RESULT

• Shirvani A, Shamszadeh S, Eghbal MJ, Marvasti LA, Asgary S. Effect of preoperative oral analgesics on pulpal anesthesia in patients with irreversible pulpitis-a systematic review and meta-analysis. Clin Oral Investig. 2017 Jan;21(1):43-52. doi: 10.1007/s00784-016-1974-1. Epub 2016 Nov 11.

  PMID: 27837343 RESULT

• Pozzi A, Gallelli L. Pain management for dentists: the role of ibuprofen. Ann Stomatol (Roma). 2011 Jul;2(3-4 Suppl):3-24. Epub 2012 Apr 15. No abstract available.

  PMID: 22888399 RESULT

• Hargreaves K, Abbott PV. Drugs for pain management in dentistry. Aust Dent J. 2005 Dec;50(4 Suppl 2):S14-22. doi: 10.1111/j.1834-7819.2005.tb00378.x.

  PMID: 16416713 RESULT

Related Links

• ADA-Evidence-based clinical practice guideline for the pharmacologic management of acute dental pain in children.
• Related Info

MeSH Terms

Conditions

Toothache

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Assistant Professor Merve Bilmez Selen
• Organization: Inonu

merve.selen@inonu.edu.tr

5457673089

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. lecturer

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 11, 2025
• Study Start: August 2, 2025
• Primary Completion: August 11, 2025
• Study Completion: August 15, 2025
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)