generalized chronic periodontitis MedDRA version: 19.1 Level: LLT Classification code 10009102 Term: Chronic periodontitis System Organ Class: 100000004862
Conditions
Interventions
Trade Name: D-CURE
Pharmaceutical Form: Oral solution
INN or Proposed INN: colecalciferol
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
Concentration unit: IU internatio
Sponsors
Cliniques universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the clinical outcomes of the administration of the vitamin D as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP);Secondary Objective: Not applicable;Primary end point(s): The primary objective of this study is to determine the effect of vitamin D on PPD .;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives are to determine the effect of vitamin D on parameters associated with periodontal health such as CAL, BOP, and the levels of hs-CRP, HDL.;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Belgium
Contacts
Public ContactEcole de Médecine Dentaire
Cliniques universitaires Saint-Luc
Outcome results
None listed