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Effect of Vitamin D on Postoperative Pain in Symptomatic Irreversible Pulpitis

NCT07579637 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-12

No results posted yet for this study

Summary

Vitamin D deficiency (VDD) is a prevalent global health concern that has been linked to altered pain perception through its effects on inflammatory pathways, nociceptor activity, and neurotrophic signaling. While its role in chronic pain has been widely studied, limited evidence exists regarding its impact on acute postoperative dental pain. This triple-blinded randomized controlled clinical trial aims to evaluate the effect of moderate-dose vitamin D supplementation on postoperative pain following single-visit root canal treatment (RCT) in patients with symptomatic irreversible pulpitis affecting mandibular first molars. A total of 54 vitamin D-deficient patients (serum 25(OH)D \<30 nmol/L), aged 20-45 years, will be randomly allocated into three groups: a single preoperative dose group (150,000 IU vitamin D₃), a fractionated dose group (50,000 IU over three consecutive days), and a placebo group. All participants will undergo standardized single-visit RCT procedures. Postoperative pain will be assessed using a Modified Visual Analog Scale (VAS) at baseline and at 6, 12, 24, and 48 hours post-treatment, while analgesic intake will be recorded as a secondary outcome. It is hypothesized that vitamin D supplementation will significantly reduce postoperative pain levels and analgesic consumption compared to placebo. This study seeks to explore vitamin D as a safe, cost-effective adjunct in endodontic pain management, with potential implications for improving clinical outcomes in patients with VDD undergoing RCT.

Conditions

  • Pulpitis - Irreversible
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

Preoperative supplementation of 150000 IU Vitamin D3 soft gel oral capsules with dietary fat prior to single visit root canal treatment in mandibular first molar with symptomatic irreversible pulpitis

DIETARY_SUPPLEMENT

Vitamin D3

50000 IU preoperative Vit D3 oral soft gel capsule with dietary fat prior to root canal treatment in mandibular first molars with symptomatic irreversible pulpitis followed by 50000 IU on the second day and 50000 IU on the third day.

DIETARY_SUPPLEMENT

Placebo

Matched soft Gel capsules to Vit D3 capsules, 3 oral soft gel capsules preoperative to single visit root canal treatment in mandibular first molars with symptomatic irreversible pulpitis

Sponsors & Collaborators

  • Future University in Egypt

    lead OTHER

Principal Investigators

  • Hesham Mohamed Salah, PHD in Endodontics · Future University in Egypt

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-05-01
Completion
2026-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579637 on ClinicalTrials.gov