Effect of Vitamin D on Postoperative Pain in Symptomatic Irreversible Pulpitis (NCT07579637) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Vitamin D on Postoperative Pain in Symptomatic Irreversible Pulpitis
Egypt54 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
20 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Pain
Timeframe: Preoperative and on the 6th, 12th, 24th, 48th hours postoperative