Vitamin D insufficiency undergoing tooth extraction
Conditions
Interventions
Trade Name: Rokivit D3
Product Name: Rokivit D3
Pharmaceutical Form: Capsule
INN or Proposed INN: CHOLECALCIFEROL
Other descriptive name: VITAMIN D3
Concentration unit: IU international unit(s)
Concen
Sponsors
University Clinic of Dentistry, Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age: 18 to 50 years • Gender: female/male • Patients with insufficient serum 25(OH)D3 levels: =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known allergies/intolerances against any ingredients of the IMP • Pregnant/lactating women • Current or former smokers • Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the surgeons or periodontists, might confound the results of the study or poses an additional risk to the subject during participation in the study o Renal insufficiency o Primary hyperparathyroidism o Malignancy o Other severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, …) o Diabetes mellitus o Obesity class III (body mass index, BMI =40) o Medical conditions requiring daily calcium or antacid use o Medical conditions that result in a high calcium level in the blood or increased calcium excretion in the urine (e.g. as with treatment with certain medicines [benzothiazine derivates] • Current or previous treatments / therapies, including o Anticoagulants o Immunosuppressive therapy o Systemic antibiotics (within the last 3 months) o Chronic use of non-steroidal anti-inflammatory drugs, aspirin and corticosteroids o Vitamin, mineral or herbal preparations or food supplements (within the last 3 months) o Rifampicin or isoniazid (against tuberculosis). Tuberculosis will be regarded as a severe pathology, and thus, patients will not be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the wound healing score determined using the “Inflammatory Proliferative Remodeling Wound Healing Scale” (IRP-Score) between wisdom tooth extraction without and with a previous short-term Vitamin D3 supplementation for vitamin D insufficient patients with a bilateral indication for wisdom tooth extraction.;Secondary Objective: 1. To assess the salivary levels of several pro-inflammatory mediators, particularly interleukin (IL)-1b, IL-8, and myeloid-related protein (MRP)-8/14, measured before and at different time points after wisdom tooth extraction with and without previous vitamin D3 supplementation and to compare the time course of the inflammatory reaction. ;Primary end point(s): To compare the wound healing score determined using the “Inflammatory Proliferative Remodeling Wound Healing Scale” (IRP-Score) between wisdom tooth extraction without and with a previous short-term Vitamin D3 supplementation for vitamin D insufficient patients with a bilateral indication for wisdom tooth extraction.;Timepoint(s) of evaluation of this end point: See section E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess the salivary levels of several pro-inflammatory mediators, particularly interleukin (IL)-1b, IL-8, and myeloid-related protein (MRP)-8/14, measured before and at different time points after wisdom tooth extraction with and without previous vitamin D3 supplementation and to compare the time course of the inflammatory reaction.;Timepoint(s) of evaluation of this end point: See section E.5.2 | — |
Countries
Austria
Contacts
Public ContactPrincipal Investigator
Univ. Prof. DDr. Christian
Outcome results
None listed