THE IMPACT OF VITAMIN D3 HIGH DOSES SUPPLEMENTATION ON SOFT TISSUE WOUND HEALING AFTER MANDIBULAR THIRD MOLAR (M3) REMOVAL: A PILOT STUDY
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
The overall aim of this project is to investigate the influence of high-dose short-term vitamin D3 supplementation on soft tissue wound healing after wisdom tooth extraction (third molar, M3).
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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. 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
排除标准
- •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.
结局指标
主要结局
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)
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)
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)
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)
serum level of 25(OH)D3 changes in healthy participants after the vitamin D3 supplementation
serum level of 25(OH)D3 changes in healthy participants after the vitamin D3 supplementation
frequency and severity of adverse events (AE)
frequency and severity of adverse events (AE)
次要结局
- 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.
研究者
Clinic of Dentistry
Scientific
Medical University Of Vienna