Study on High-Dose Vitamin D3 and Glycerol for Improving Wound Healing After Wisdom Tooth Removal in Patients with Vitamin D Insufficiency

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What is this study about?

This clinical trial is focused on studying the effects of high-dose Vitamin D3 supplementation on the healing of soft tissue wounds after the removal of wisdom teeth, also known as third molars. The study is particularly interested in individuals who have Vitamin D insufficiency and are undergoing tooth extraction. The treatment being tested involves the use of colecalciferol, which is another name for Vitamin D3, combined with glycerol. Participants will receive this treatment to see if it helps improve the healing process after their wisdom teeth are removed.

The purpose of the study is to investigate how short-term, high-dose Vitamin D3 supplementation might influence the healing of soft tissues after wisdom tooth extraction. Participants will be given Vitamin D3 supplements and their healing process will be monitored. The study will compare the healing of the first extracted wisdom tooth without Vitamin D3 intervention to the second extracted wisdom tooth with Vitamin D3 intervention. This will help researchers understand if Vitamin D3 can make a difference in the healing process.

Throughout the study, researchers will also measure certain substances in saliva and blood to see how they change with and without Vitamin D3 supplementation. These substances include interleukin (IL)-1b, IL-8, and myeloid-related protein (MRP)-8/14, which are involved in the body’s inflammatory response. The study aims to provide insights into whether Vitamin D3 can help reduce inflammation and improve healing after wisdom tooth extraction.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes checking your age, gender, and vitamin D levels. You must be between 18 to 50 years old, generally healthy, and have low vitamin D levels.

3 first tooth extraction

The first wisdom tooth extraction will take place. No vitamin D3 supplementation will be given before this procedure. This serves as a baseline for comparison.

4 vitamin D3 supplementation

You will begin taking a high dose of vitamin D3 orally. The specific dosage and frequency will be provided by the study team. This supplementation is intended to assess its impact on wound healing.

5 second tooth extraction

The second wisdom tooth extraction will occur after the vitamin D3 supplementation period. This allows for comparison of healing with and without the vitamin D3 intervention.

6 follow-up assessments

Follow-up assessments will be conducted to monitor wound healing and any changes in vitamin D levels. Saliva samples may be collected to measure certain proteins related to inflammation.

7 completion of study

Upon completion of the study, you will receive a final assessment. This will include a review of your overall health and any changes observed during the study period.

Who Can Join the Study?

Age: 18 to 50 years
Gender: female or male
Patients with insufficient vitamin D levels: This means having a blood level of vitamin D less than 75 nmol/l (or less than 30 ng/ml)
Generally healthy individuals of Caucasian descent
Need to have both wisdom teeth in the upper jaw removed
Ability to follow instructions given by the X-ray technologist
Must provide written consent to participate in the study

Who Cannot Join the Study?

Patients who are not experiencing Vitamin D insufficiency cannot participate. Vitamin D insufficiency means having lower than normal levels of Vitamin D in the body.
Patients who are not undergoing a tooth extraction cannot participate. A tooth extraction is a procedure where a tooth is removed from the mouth.
Patients who are not having their wisdom teeth removed cannot participate. Wisdom teeth are the last set of molars that most people get in their late teens or early twenties.
Patients who are not willing to take high-dose Vitamin D3 supplements cannot participate. Vitamin D3 supplements are pills or liquids taken to increase Vitamin D levels in the body.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

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Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Vitamin D3 is a supplement that is being tested in this study to see if it can help improve the healing of soft tissues after the removal of a wisdom tooth. Vitamin D3 is known for its role in bone health and immune function, and the researchers want to find out if taking high doses of it for a short time can make the healing process faster or better after dental surgery.

Investigated diseases:

Vitamin D deficiency

Vitamin D Insufficiency – Vitamin D insufficiency is a condition where the body does not have enough vitamin D to maintain optimal health. This vitamin is crucial for calcium absorption, bone health, and immune function. When vitamin D levels are low, it can lead to weakened bones and muscles, increasing the risk of fractures and falls. The condition can also affect the immune system, potentially leading to increased susceptibility to infections. Over time, insufficient vitamin D can contribute to the development of osteoporosis, a condition characterized by brittle and fragile bones. It is often identified through blood tests measuring the level of 25-hydroxyvitamin D.

Trial ID:

2024-518897-15-00

Protocol code:

VitDM3BH

Trial Phase:

Therapeutic exploratory (Phase II)

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