THE IMPACT OF VITAMIN D3 HIGH DOSES SUPPLEMENTATTION ON SOFT TISSUE WOUND-HEALING AFTER MANDIBULAR THIRD MOLAR (M3) REMOVAL: A PILOT STUDY - VitDM3BH

niversity Clinic of Dentistry, Medical University of Vienna0 个研究点目标入组 20 人开始时间: 2021年2月8日最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•Age: 18 to 50 years
•Gender: female/male
•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 (5). Hence, we expect a sufficient number of participants corresponding to the inclusion criteria (serum 25(OH)D3 levels <75 nmol/l (30ng/ml).
•Generally healthy Caucasian
•Indication for bilateral wisdom tooth extraction from physiologically positioned wisdom teeth in the upper jaw
•Patients who are able to follow the instructions of the X-ray technologist
•Given written informed consent form for participation in the study
•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 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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
•oRenal insufficiency
•oPrimary hyperparathyroidism
•oMalignancy
•oOther severe diseases (e.g. renal, hepatic, thyroid disease, bone metabolic diseases, rheumatoid osteoarthritis, human immunodeficiency syndrome, …)
•oDiabetes mellitus
•oObesity class III (body mass index, BMI =40)
•oMedical conditions requiring daily calcium or antacid use
•oMedical 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
•oAnticoagulants
•oImmunosuppressive therapy
•oSystemic antibiotics (within the last 3 months)
•oChronic use of non-steroidal anti-inflammatory drugs, aspirin and corticosteroids
•oVitamin, mineral or herbal preparations or food supplements (within the last 3 months)
•oRifampicin or isoniazid (against tuberculosis). Tuberculosis will be regarded as a severe pathology, and thus, patients will not be included in the study.

发起方

niversity Clinic of Dentistry, Medical University of Vienna