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The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation

Plain-language guide to NCT06707909: phase 4 randomized trial of Vitamin D, K2, Magnesium and Zinc, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06707909
Phase
phase 4
Status
recruiting participants
Start
2025-02-15
Completion (planned or actual)
2025-10-25
Participants
20 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Socket Preservation
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 4 trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.

This study is a randomized controlled trial comparing the effects of socket grafting with crushed vitamin K2 (menaquinone)capsules versus no grafting on bone density and socket dimensions following tooth extraction.

Patients are randomly assigned to one of two groups: Study Group (Group I): Patients receive socket grafting with crushed vitamin K2 (menaquinone) capsules.

The socket is covered with an absorbent sponge, and non-resorbable sutures are placed to stabilize the graft material and achieve soft tissue stability.

It had two arms (groups): Menaquinone group (active comparator) and control group (no intervention).

The registry classes the interventions as drug.

More on the Plan

The study is designed as a randomized controlled trial to investigate the effects of socket grafting with crushed vitamin K2 (menaquinone) capsules compared to no grafting on bone density and socket dimensions following tooth extraction.

Participants: Patients scheduled for tooth extraction are enrolled in the study and randomized into two equal groups. 11\.

Interventions \- Patients were randomly divided into two equal groups.

Bone density and socket dimensions will be evaluated immediately after extraction with graft material and after 4 months by using a cone beam computed tomography (CBCT) radiograph and at the time of implant placement core biopsy will be taken.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Patients requiring extraction of mandibular single-rooted teeth.

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: • patients with systemic conditions affecting bone metabolism; allergies or sensitivities to hydroxyapatite or vitamin k2; untreated or residual periodontal disease;.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Vitamin D, K2, Magnesium and Zinc study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2025-02-15 with completion listed for 2025-10-25.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Marginal bone loss (time frame: baseline and 4 month after extraction).

It also tracked 2 secondary outcomes, for example Primary stability and amount of new bone formation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Vitamin D, K2, Magnesium and Zinc in 20 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.

Our Notes on the Compound

Vitamin D, K2, Magnesium and Zinc: Magnesium is described as required for AMPK to function.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.