Effects of vitamin D supplementation during a non-surgical treatment of generalized chronic periodontitis: a randomized double-blinded placebo-controlled clinical trial - Vitamin D supplementation in treating periodontitis

Cliniques universitaires Saint-Luc0 个研究点目标入组 30 人开始时间: 2017年1月17日最近更新: 2020年9月28日

试验速览

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•All subjects who are in good general health and were diagnosed with GChP based on the current classification of the American Academy of Periodontology will be included:
•- =30 years of age,
•- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction),
•- a minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) =5 mm,
•- at least 30% of the sites with PPD and CAL =4 mm and bleeding on probing (BOP);
•- Caucasians (defined as European and North African);
•- subjects who present a 25(OH)D concentration <30 ng/mL.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•- pregnancy
•- breastfeeding
•- current smoking and former smoking within the past 5 years/smoking status will be recorded as smoker (current) or non-smoker (never or former);
•- systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
•- SRP in the previous 12 months;
•- antibiotic therapy in the previous 6 months;
•- long-term intake of anti-inflammatory medications;
•- need for antibiotic pre-medication for routine dental therapy;
•- any current ongoing immunological, neoplasic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological, or psychiatric abnormalities or medical disease;
•- subjects who used a UV light solarium or any type of vitamin D supplement within two months before the screening visit or planned to travel outside European countries during the study
•- subjets under treatment with drugs that may interfere with vitamin D metabolism (e.g., phenobarbital, phenytoin, and glucocorticoids) and those with past or current history of granulomatosis, especially sarcoidosis, urinary lithiasis, and osteomalacia;
•- subjects who present a 25(OH)D concentration >30 ng/mL, serum creatinine >150 ????mol/L and albumin corrected serum calcium >2.65 mmol/L (corresponding to 10.6 mg/dL) at screening,
•- any sensitivity or allergy to any of the products that will be used in the study or a history of drug and/or alcohol abuse.

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