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

NCT06707909 | Recruiting Phase 4

• 1 other identifier: CEBD-CU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. Control Group (Group II): Patients undergo socket healing without grafting. The socket is covered with an absorbent sponge, and non-resorbable sutures are placed over it. Outcome measures include bone socket dimensions evaluated immediately after extraction with graft material, as well as assessment after 4 months using cone beam computed tomography (CBCT) radiographs. Additionally, core biopsies are taken at the time of implant placement.

Conditions

Socket Preservation

Outcome Measures

Primary Outcomes (1)

• Marginal bone loss

  At the time of extraction, CBCT imaging will provide baseline data on the initial bone structure This baseline measurement serves as a reference point for evaluating any subsequent changes in bone density and morphology. After four months, another CBCT scan will be conducted to assess the amount of marginal bone loss that has occurred since the initial extraction. By comparing the post-extraction CBCT images with those taken after four months, researchers can quantify any changes in bone volume and identify any areas of concern related to bone resorption. The unit of measurement for the primary outcome, vertical bone change (socket height), is millimeters (mm).

  baseline and 4 month after extraction

Secondary Outcomes (2)

• Primary stability

  at time of implant placment

• amount of new bone formation

  baseline and 4 month after extraction

Other Outcomes (1)

• Secondary stability

  4 month post-implant placement

Study Arms (2)

Menaquinone group

ACTIVE COMPARATOR

Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline. the socket will be filled with crushed capsule of vitamin k2(menaquinone) and cover with an absorbent sponge a Figure of eight tension-free non-resorbable 3-0 sutures will be placed over the filled socket to stabilize the graft material in the socket and to achieve soft tissue stability. 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 for histomorphometric analysis.

Drug: Menaquinone

control group

NO INTERVENTION

Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline. the socket will be left to heal without grafting, and it will be covered with an absorbent sponge. A figure-of-eight tension-free non-resorbable 3-0 sutures will be placed over the socket. 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 for histomorphometric analysis.

Interventions

Menaquinone DRUG

the socket will be filled with crushed capsule of vitamin k2 menaquinone in study group

Also known as: vitamin k2 (Menaquinone)

Menaquinone group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring extraction of mandibular single-rooted teeth.

You may not qualify if:

• Patients with systemic conditions affecting bone metabolism.
• Allergies or sensitivities to hydroxyapatite or Vitamin K2
• Untreated or residual periodontal disease;
• Uncontrolled diabetes (HbA1c \> 7.5%);
• Head and/or neck radiotherapy
• Immunosuppressive therapy
• Pregnant or nursing
• Substance abuse
• Treated or under treatment with intravenous amino-bisphosphonates
• Patients participating in other studies, if the present protocol could not be properly followed.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo

Cairo, Cairo Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Vitamin K 2

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Central Study Contacts

mohamed elsawaf, BDS

CONTACT

01124145951; mohamed.elsawaf@dentistry.cu.edu.eg

mohamed Khashaba, Professor

CONTACT

01094331092

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 27, 2024
• Study Start: February 15, 2025
• Primary Completion: October 25, 2025
• Study Completion: November 24, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

EG (1)