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

The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trail

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.

Study Overview

• Status: Recruiting
• Conditions: Socket Preservation
• Intervention / Treatment: Drug: Menaquinone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: mohamed elsawaf, BDS; Phone Number: 01124145951; Email: mohamed.elsawaf@dentistry.cu.edu.eg
• Study Contact Backup: Name: mohamed Khashaba, Professor; Phone Number: 01094331092

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo
    • Contact: mohamed elsawaf, BDS; Phone Number: 01124145951; Email: mohamed.elsawaf@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:• Age > 18 years without other age or gender restrictions.

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Menaquinone; the socket will be filled with crushed capsule of vitamin k2 menaquinone in study group; Other Names: vitamin k2 (Menaquinone)
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary stability	For the primary stability assessment, the Implant Stability Quotient (ISQ) will be utilized. ISQ is a non-invasive and widely used method for evaluating the initial stability of dental implants during placement. Unit of Measurement: Implant Stability Quotient (ISQ)	at time of implant placment
amount of new bone formation	amount of new bone formation," histomorphometric analysis will be employed. This method involves the microscopic examination and quantification of bone tissue characteristics to assess the extent of bone formation. Histomorphometric analysis allows researchers to evaluate the quality and quantity of newly formed bone in the extraction site or implantation site. It involves taking tissue samples (biopsies) from the area of interest and then processing these samples for microscopic examination. Unit of Measurement: Bone area percentage (%)	baseline and 4 month after extraction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary stability	the Implant Stability Quotient (ISQ) will be utilized. ISQ is a non-invasive and widely used method for evaluating the stability. Unit of Measurement: Implant Stability Quotient (ISQ)	4 month post-implant placement

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): October 25, 2025
• Study Completion (Estimated): November 24, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 2, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Micronutrients; Vitamins; Vitamin K; Vitamin K 2
• Other Study ID Numbers: CEBD-CU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No