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"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Future University in Egypt
- Enrollment
- 54
- Locations
- 1
Study Overview
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.
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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
- •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.
Investigators
Shady Mamdouh Elsayed Elsayed Badawy
Clinical Instructor
Future University in Egypt