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Effect of Vitamin D on Postoperative Pain in Symptomatic Irreversible Pulpitis

5 maggio 2026 aggiornato da: Shady Mamdouh Elsayed Elsayed Badawy, Future University in Egypt

The Effect of Vitamin D Supplementation Protocol on Post Operative Pain in Patients With Symptomatic Irreversible Pulpitis of Mandibular First Molar Teeth After Root Canal Treatment. "A Triple Blinded Clinical Randomized Control Trial"

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study is a triple-blinded randomized controlled clinical trial designed to evaluate the effect of vitamin D supplementation on postoperative pain following single-visit root canal treatment (RCT) in patients with symptomatic irreversible pulpitis affecting mandibular first molars.

Vitamin D deficiency (VDD) is highly prevalent worldwide and has been increasingly linked to pain modulation mechanisms, including effects on nociceptors, inflammatory pathways, neurotrophic factors, and immune responses. Despite evidence supporting its role in chronic pain, limited research has investigated its effect on acute dental pain, particularly postoperative endodontic pain.

Aim

To assess whether moderate-dose vitamin D supplementation reduces postoperative pain levels in vitamin D-deficient patients undergoing RCT.

Study Design & Participants Sample size: 54 patients (18 per group)

Population: Adults (20-45 years) with:

Vitamin D deficiency (<30 nmol/L) Symptomatic irreversible pulpitis in mandibular first molars All treatments are performed in a single visit under standardized clinical conditions.

Intervention Groups Group A: Single high dose (150,000 IU vitamin D₃) preoperatively Group B: Fractionated dose (50,000 IU for 3 days: pre-op + 2 days post-op) Group C: Placebo

Vitamin D is administered with dietary fat to enhance absorption.

Outcome Measures

Primary outcome:

Postoperative pain assessed using Modified Visual Analog Scale (VAS) at:

Preoperative baseline 6, 12, 24, and 48 hours post-treatment

Secondary outcome:

Analgesic intake (number of patients and tablets consumed) Methodology Highlights

Standardized RCT protocol including:

Rubber dam isolation Rotary instrumentation (crown-down technique) Sodium hypochlorite irrigation (5.25%) Continuous wave obturation Only ibuprofen (600 mg) allowed as rescue analgesic Strict triple blinding (patient, operator, assessor) to eliminate bias Hypothesis Null hypothesis: No difference in postoperative pain between vitamin D and placebo groups.

Significance

This study addresses a gap in endodontic pain management, exploring vitamin D as a potential adjunctive, low-cost, and biologically plausible analgesic strategy. If effective, it may influence clinical protocols for managing acute pulpitis-related pain and postoperative discomfort.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

54

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Egitto
    • Select A State Or Province
      • New Cairo, Select A State Or Province, Egitto
        • Future University in Egypt

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Non-compliant patients to follow ups.
  • Patients with very poor oral hygiene.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Single dose 150000 IU 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
Integratore alimentare: 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
Integratore alimentare: 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.
Comparatore attivo: 150000 IU Vitamin D3 on 3 consecutive days 50000 IU each.
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.
Integratore alimentare: 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
Integratore alimentare: 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.
Comparatore placebo: 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
Integratore alimentare: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative Pain
Lasso di tempo: Preoperative and on the 6th, 12th, 24th, 48th hours postoperative
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of analgesic intake
Lasso di tempo: 6th,12th,24th and 48th hours postoperative
Patients were advised to take oral ibuprofen 600 mg only in cases of severe or persistent pain and were asked to follow up intervals of 6,12,24 and 48 hours postoperative about the number of taken analgesic pills if any
6th,12th,24th and 48th hours postoperative

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Future University in Egypt

Investigatori

  • Direttore dello studio: Hesham Mohamed Salah, PHD in Endodontics, Future University in Egypt

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 novembre 2025

Completamento primario (Effettivo)

1 maggio 2026

Completamento dello studio (Stimato)

1 agosto 2026

Date di iscrizione allo studio

Primo inviato

5 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FUE.REC(24)/4-2025

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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