Vitamin D supplementation in treating periodontitis

Phase 1

• Conditions: generalized chronic periodontitis; MedDRA version: 19.1Level: LLTClassification code 10009102Term: Chronic periodontitisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2016-005062-61-BE
• Lead Sponsor: Cliniques universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-17
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified