2023-503671-16-00招募中4 期
Effect of vitamin D3 supplementation in participants with periodontitis and vitamin D deficiency: A randomized, interventional, parallel, placebo-controlled, double blind clinical trial.
Laboratoires S.M.B.2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年12月5日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm.
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Test - Placebo
- 盲法
- Double (Monitor, Analyst, Investigator, Subject, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm.
Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm.
次要结局
- Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean probing pocket depth (PPD).
- Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean clinical attachment level (CAL).
- Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 4mm
- Absolute change from baseline (V2) to week 12 (V3) in the number of residual PPD ≥ 5mm.
- Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 6mm
- Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the bleeding on probing (BoP)
- Absolute change from baseline to week 12 (V3) and 24 (V4) on the plaque control (O’Leary)
- Percentage of participants with ≤4 sites with PPD ≥ 5mm at week 24 (V4)
- Absolute change from baseline (V1) to week 12 (V3) and 24 (V4) in the 25(OH)D3 serum concentration.
- Percentage of participants reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 24 (V4).
- Incidence in adverse events including adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).
- Change from baseline in laboratory data including the assessment of serum concentration of calcium and phosphate throughout the clinical trial.
研究者
Sophie De Niet
Scientific
Laboratoires S.M.B.
研究点 (2)
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