VitDM3BH Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Stomatognathic Diseases [C07]

Trial duration

7 Jul 2021 → ongoing

Decision date (initial)

2024-12-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-518897-15-00

EudraCT number

2021-000200-38

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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).

Secondary objectives 1

1. are 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.

Conditions and MedDRA coding

Vitamin D insufficiency undergoing tooth extraction

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age: 18 to 50 years
2. Gender: female/male
3. 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)
4. Generally healthy Caucasian
5. Indication for bilateral wisdom tooth extraction from physiologically positioned wisdom teeth in the upper jaw
6. Patients who are able to follow the instructions of the X-ray technologist
7. Given written informed consent form for participation in the study

Exclusion criteria 5

1. Known allergies/intolerances against any ingredients of the IMP
2. Pregnant/lactating women
3. Current or former smokers
4. 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]
5. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. 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)
2. 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)
3. serum level of 25(OH)D3 changes in healthy participants after the vitamin D3 supplementation
4. frequency and severity of adverse events (AE)

Secondary endpoints 1

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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Clinic of Dentistry

Public contact point

Organisation

Medical University Of Vienna

Contact name

Clinic of Dentistry

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications