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

Phase 1

• Conditions: Vitamin D insufficiency undergoing tooth extraction; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2021-000200-38-AT
• Lead Sponsor: niversity Clinic of Dentistry, Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•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

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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified