COLECALCIFEROL, GLYCEROL for Vitamin D insufficiency | Third molar (wisdom tooth) extraction

Inclusion criteria

• {"criterion_text":"- Age: 18 to 50 years"}
• {"criterion_text":"- Gender: female/male"}
• {"criterion_text":"- Patients with insufficient serum 25(OH)D3 levels: <75 nmol/l (<30ng/ml) According to a recently published study from Germany, the prevalence of vitamin D3 deficiency, classified as serum 25(OH)D3 levels <50 nmol/l (20 ng/ml) is 60-75% in winter and 30-45% in summer. Hence, we expect a sufficient number of participants corresponding to the inclusion criteria (serum 25(OH)D3 levels <75 nmol/l (30ng/ml)"}
• {"criterion_text":"- Generally healthy Caucasian"}
• {"criterion_text":"- Indication for bilateral wisdom tooth extraction from physiologically positioned wisdom teeth in the upper jaw"}
• {"criterion_text":"- Patients who are able to follow the instructions of the X-ray technologist"}
• {"criterion_text":"- Given written informed consent form for participation in the study"}

Exclusion criteria

• {"criterion_text":"- Known allergies/intolerances against any ingredients of the IMP"}
• {"criterion_text":"- Pregnant/lactating women"}
• {"criterion_text":"- Current or former smokers"}
• {"criterion_text":"- 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])"}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- mean total IPR scores and subscores for the different wound healing phases between without (first extracted upper third molar) and with vitamin D3 intervention (second extracted upper third molar)","definition_or_measurement_approach":"Comparison of mean total IPR scores and subscores across wound healing phases between the first extracted upper third molar without supplementation and the second extracted upper third molar with vitamin D3 intervention (within-subject comparison)."}
• {"endpoint_text":"- mean salivary levels of IL-1β, IL-8, and MRP-8/14 and the dynamic of their alteration between without (first extracted upper third molar) and with vitamin D3 intervention (second extracted upper third molar)","definition_or_measurement_approach":"Measurement of salivary IL-1β, IL-8, and MRP-8/14 levels at defined time points before and after tooth extraction and comparison of their time-course between the no-supplement and vitamin D3 supplemented conditions (within-subject)."}
• {"endpoint_text":"- serum level of 25(OH)D3 changes in healthy participants after the vitamin D3 supplementation","definition_or_measurement_approach":"Measurement of serum 25(OH)D3 concentrations before and after vitamin D3 supplementation to assess change."}
• {"endpoint_text":"- frequency and severity of adverse events (AE)","definition_or_measurement_approach":"Recording and grading of adverse events; assessment of frequency and severity during the study period."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Serial measurement of salivary pro-inflammatory mediators (IL-1b, IL-8, MRP-8/14) at multiple time points before and after extraction; comparison of temporal profiles between extractions with and without prior vitamin D3 supplementation."}

Austria

Earliest CTIS Part Ii Submission Date

10-10-2024

Latest Decision Or Authorization Date

29-08-2025

Processing Time Days

323

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria