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Recruiting Phase 4 NCT06707909

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

Trial Parameters

Condition Socket Preservation
Sponsor Cairo University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-02-15
Completion 2025-10-25
Interventions
Menaquinone

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.

Eligibility Criteria

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.

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