Effect of Vitamin D on Postoperative Pain in Symptomatic Irreversible Pulpitis

NCT07579637 | Active Not Recruiting DMC

• 1 other identifier: FUE.REC(24)/4-2025
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitamin D; Post operative pain; root canal treatment; symptomatic irreversible pulpitis; mandibular first molar; Vitamin D deficiency

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  A form will be given to patients to be filled in with respect to post-operative pain: preoperative and on the 6th, 12th, 24th, 48th hour postoperative. The presence of post-operative pain is accessed by visual analog scale (VAS) scale (0-10), where 0 showed no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, and 10 worst possible pain.

  Preoperative and on the 6th, 12th, 24th, 48th hours postoperative

Secondary Outcomes (1)

• Number of analgesic intake

  6th,12th,24th and 48th hours postoperative

Study Arms (3)

Single dose 150000 IU Vitamin D3

ACTIVE COMPARATOR

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

150000 IU Vitamin D3 on 3 consecutive days 50000 IU each.

ACTIVE COMPARATOR

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: Vitamin D3

Placebo Comparator

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo Comparator

Vitamin D3 DIETARY_SUPPLEMENT

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

Single dose 150000 IU Vitamin D3

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with serum 25-hydroxyvitamin D level below 30 nmol/L with no vitamin D supplementation for the preceding 3 months.
• Patients diagnosed with symptomatic irreversible pulpitis.
• Mandibular first molar:
• Classification of root canal configuration according to Weine's classification:
• Distal root: with one portal of exit
• Mesial root: Type III, two separate and distinct canals extend from the pulp chamber to the apex.
• Patients with moderate to severe pre-operative pain with pain score from 6-10.
• Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
• The age range is between 20 to 45 years.
• Patients have restorable mandibular permanent molars that were diagnosed with symptomatic irreversible pulpitis.
• Positive patient's acceptance for participating in the study and signing informed consent

You may not qualify if:

• Patients that have been taking vitamin D supplements in the last 3 months.
• Patients with serum 25-hydroxyvitamin D level above 30 nmol/L.
• Patients diagnosed with necrosis, partial necrosis, acute or chronic abscess.
• Presence of periapical radiolucency.
• Patients with systemic conditions that may affect pain perception (e.g., fibromyalgia, diabetes, chronic pain disorders).
• Pregnant or lactating females.
• Psychologically disturbed patients.
• Patients with a history of allergy to any medication used in the study are excluded.
• Patients with mild to moderate pain with pain scores less than 6.
• Teeth that have:
• Periodontally affected molars with grade 2 or 3 mobility.
• Non-restorable teeth.
• Abnormal anatomy and calcified canals.
• Previous root canal treatment.
• Patients above 45 years old or below 20 years old.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

New Cairo, Select A State Or Province, Egypt

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Pain, Postoperative

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Hesham Mohamed Salah, PHD in Endodontics

  Future University in Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)