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

NCT ID: NCT06707909

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-11-24

Brief Summary

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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.

Detailed Description

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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.

In both groups:

Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline.

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.

In group I (study): the socket will be filled with crushed capsule of vitamin k211. Interventions

\- Patients were randomly divided into two equal groups.

In both groups:

Tooth extraction will perform under local anesthesia All sockets were thoroughly curetted to remove granulation tissue, followed by irrigation and rinsing with sterile saline.

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.

In group I (study): the socket will be filled with crushed capsule of vitamin k2 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.

in group II (control): 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.

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.

in group II (control): 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.

Conditions

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Socket Preservation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Menaquinone group

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.

Group Type ACTIVE_COMPARATOR

Menaquinone

Intervention Type DRUG

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

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Menaquinone

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

Intervention Type DRUG

Other Intervention Names

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vitamin k2 (Menaquinone)

Eligibility Criteria

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Inclusion Criteria

* Patients requiring extraction of mandibular single-rooted teeth.

Exclusion Criteria

* • 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Hussien Mohamed Elsawaf

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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mohamed elsawaf, BDS

Role: CONTACT

01124145951

mohamed Khashaba, Professor

Role: CONTACT

01094331092

Facility Contacts

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mohamed elsawaf, BDS

Role: primary

01124145951

Other Identifiers

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CEBD-CU

Identifier Type: -

Identifier Source: org_study_id

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