Pulpitis - IrreversibleNCT07579637
Effect of Vitamin D on Postoperative Pain in Symptomatic Irreversible Pulpitis
A study testing Vitamin D3 in people with Pulpitis - Irreversible and Vitamin D Deficiency, run by Future University in Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Pulpitis - Irreversible, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
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.
- Conditions
- Pulpitis - Irreversible, Vitamin D Deficiency
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D, Post operative pain, root canal treatment, symptomatic irreversible pulpitis, mandibular first molar, Vitamin D deficiency
- Medical subject headings
- Vitamin D Deficiency, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary 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
Vitamin D3Dietary supplement
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.
PlaceboDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative and on the 6th, 12th, 24th, 48th hours postoperative
Secondary outcomes (1)
Number of analgesic intake
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
Measured: 6th,12th,24th and 48th hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Nov 2025
- Primary completion1 May 2026
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Mamdouh Elsayed Elsayed Badawy, Future University in Egypt
- Investigators
- Hesham Mohamed Salah, PHD in Endodontics, Study director, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579637
- Sponsor's protocol ID
- FUE.REC(24)/4-2025
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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"
- ClinicalTrials.gov ID
- NCT07579637
- Acronym / sponsor ID
- FUE.REC(24)/4-2025
- Conditions
- Pulpitis - Irreversible, Vitamin D Deficiency
- Keywords
- Vitamin D, Post operative pain, root canal treatment, symptomatic irreversible pulpitis, mandibular first molar, Vitamin D deficiency
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose 150000 IU Vitamin D3 | Active comparator | Dietary Supplement: Vitamin D3Preoperative 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 |
| 150000 IU Vitamin D3 on 3 consecutive days 50000 IU each. | Active comparator | Dietary Supplement: Vitamin D350000 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. |
| Placebo Comparator | Placebo comparator | Dietary Supplement: PlaceboMatched 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- Distal root: with one portal of exit
- Mesial root: Type III, two separate and distinct canals extend from the pulp chamber to the apex.
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Preoperative 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 | Single dose 150000 IU Vitamin D3 |
| Vitamin D350000 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 | 150000 IU Vitamin D3 on 3 consecutive days 50000 IU each. |
| PlaceboMatched 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 Comparator |
Primary outcome
Postoperative Pain
Time frame: 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.
1 secondary outcome
Number of analgesic intake
Time frame: 6th,12th,24th and 48th hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hesham Mohamed Salah, PHD in Endodontics study director
Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Pulpitis - Irreversible and Vitamin D Deficiency, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: Preoperative and on the 6th, 12th, 24th, 48th hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.