Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT06707909

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

Led by Cairo University · Updated on 2025-02-05

20

Participants Needed

1

Research Sites

40 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age > 18 years without other age or gender restrictions
  • Patients requiring extraction of mandibular single-rooted teeth
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cairo

Cairo, Cairo Governorate, Egypt

Actively Recruiting

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Research Team

M

mohamed elsawaf, BDS

CONTACT

M

mohamed Khashaba, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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