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The subjects participating in the trial will be randomly allocated to either the group receiving the treatment under investigation (scaling and root planning (SRP) accompanied by administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction with placebo) as the control. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins. After randomization, the two groups of subjects will be followed in exactly the same way and the only differences between them will be the vitamin D/placebo that they will receive.
It is likely that a chronically low intake of vitamin D and calcium may lead to a negative calcium balance, thus causing a secondary increase in calcium removal from bone, including the alveolar bone. Such bone loss may contribute to weakening of the tooth-attachment apparatus. In addition to its action on skeletal homeostasis, vitamin D, and, in particular, its hormonally active form, 1a,25-dihydroxyvitamin D, has anti-inflammatory and antimicrobial effects via modulation of inflammatory cytokine production by immune cells and stimulated secretion of peptides with antibacterial action by cells of the monocyte-macrophage lineage.These multiple actions of vitamin D are potentially appealing for the management of patients with periodontal disease, whose pathogenesis is based on chronic bacterial-driven inflammation.
Excess of vitamin D leads to a disturbance of the calcium in the body cycle. The symptoms experienced are: weakness, fatigue, headache, nausea, vomiting, diarrhea, polyuria, calciuria, dry mouth, nighttime urination, proteinuria, increased thirst, loss ofappetite, dizziness.
In case of high blood calcium level for a prolonged period, calcium deposits (tissue calcinosis) may occur in the soft tissues, including the kidneys where they cause calculations and calcium deposits in the nephrons, blood vessels, heart, lung and skin. These effects are reversible if the intoxication is detected in time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | Procedure: SRP Dietary Supplement: Vitamin D3 Oral supplementation 25000 IU once per week for 6 months Other Name: Cholecalciferol |
|
| Placebo | Placebo Comparator | Procedure: SRP Dietary Supplement: Placebo Oral supplementation once per week for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Oral supplementation 25000 IU once per week for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sites with PPD ≥ 5 mm | up to 6 months | |
| Number of sites with PPD ≥ 6 mm | up to 6 months | |
| Number of sites with PPD ≥ 7 mm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jérôme Lasserre, PhD | Contact | 00322764 | 5719 | jerome.lasserre@uclouvain.be |
| Marina Peric, DMD | Contact | 00322764 | 5719 | marina.peric@student.uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Jérôme Lasserre, PhD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Etienne Cavalier, PhD | Professor and Head of the Department of Clinical Chemistry, CHU Sart-Tilman Liège |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32992785 | Derived | Peric M, Maiter D, Cavalier E, Lasserre JF, Toma S. The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study. Nutrients. 2020 Sep 25;12(10):2940. doi: 10.3390/nu12102940. |
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It will be decided at the end of the study
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Parallel assignment
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| Placebo | Dietary Supplement | Oral supplementation once per week for 6 months |
|
|
| up to 6 months |
| Reduction in the number of sites with PPD ≥ 5 mm | up to 6 months |
| Reduction in the number of sites with PPD ≥ 6 mm | up to 6 months |
| Reduction in the number of sites with PPD ≥ 7 mm | up to 6 months |
| Full-mouth PPD | up to 6 months |
| Full-mouth CAL | up to 6 months |
| Percentage of sites with BOP | up to 6 months |
| Percentage of sites with plaque accumulation | up to 6 months |
| Serum vitamin D concentration | 1 month before treatment and up to 6 months |
| Serum high-sensitivity C-reactive Protein (hs-CRP) | 1 month before treatment, at baseline, at 6 months |
| Serum high-density lipoprotein (HDL) cholesterol | 1 month before treatment, at baseline, at 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |