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Effect of Vitamin D supplementation in participants with periodontitis and vitamin D deficiency.
EU CTIS ID: 2023-503671-16-00
What this study is testing
The primary objective is to evaluate the efficacy of vitamin D3 as an adjunct therapy to a non-surgical periodontal treatment in the number of residual probing pocket depth ≥ 5mm in participants with chronic periodontitis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Caucasian male and female over 18 years old (18 years inclusive).
- Adult participants with confirmed diagnosis of stage III or IV periodontitis based on the classification of the European Federation of Periodontology within the last 2 months prior screening.
- Presenting more than 15 natural teeth in the mouth.
- Having a 25(OH)D3 < 30 ng/mL at the screening visit.
- Able to comply with all trial procedures.
- Provide written informed consent to participate in the trial, indicated by a personal signature and date on the informed consent form.
You likely can't join if
- Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease that would affect the progression of periodontitis.
- Chronic use of aspirin and/or NSAIDs.
- Use of any prohibited medication as detailed in the section 6.8.1 of the clinical trial protocol.
- UV light solarium use 4 weeks before the screening visit.
- Pregnancy or lactating females.
- Participants with any sensitivity or allergy to any of the active ingredients and/or excipients present in the products used within this clinical trial.
See the full eligibility criteria
- Caucasian male and female over 18 years old (18 years inclusive).
- Adult participants with confirmed diagnosis of stage III or IV periodontitis based on the classification of the European Federation of Periodontology within the last 2 months prior screening.
- Presenting more than 15 natural teeth in the mouth.
- Having a 25(OH)D3 < 30 ng/mL at the screening visit.
- Able to comply with all trial procedures.
- Provide written informed consent to participate in the trial, indicated by a personal signature and date on the informed consent form.
- If participant is a woman of childbearing potential, participant must use a highly effective contraception from screening visit until at least 28 days following the last dose of the investigational product as defined in section 13.1.2 of the Clinical Trial Protocol.
- Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease that would affect the progression of periodontitis.
- Chronic use of aspirin and/or NSAIDs.
- Use of any prohibited medication as detailed in the section 6.8.1 of the clinical trial protocol.
- UV light solarium use 4 weeks before the screening visit.
- Pregnancy or lactating females.
- Participants with any sensitivity or allergy to any of the active ingredients and/or excipients present in the products used within this clinical trial.
- Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the trial.
- Past or current granulomatosis (Besnier-Boek-Schaumann disease), sarcoidosis, nephrolithiasis, nephrocalcinosis, renal impairment or insufficiency, osteomalacia, pseudohypoparathyroidism.
- Participants with fixed or removable orthodontic appliances.
- History of active periodontal treatment (including non-surgical and surgical therapy) within the last 6 months prior screening.
- Planned tooth extraction after visit 2. Any tooth extraction should be performed no later than randomization day/treatment start if necessary.
- Smokers of more than 10 cigarettes per day
- Hypercalcemia at screening.
- Systemic antibiotic prophylaxis prior treatment or systemic antibiotic for maxillofacial-ENT (ear, nose and throat) infections in the previous 3 months prior screening.
- Use of any vitamin D supplementation alone or in association.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.