NCT06707909 The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
| NCT ID | NCT06707909 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Cairo University |
| Condition | Socket Preservation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2025-10-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2025-02-15 with a primary completion date of 2025-10-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06707909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Socket Preservation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06707909 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06707909 currently recruiting?
Yes, NCT06707909 is actively recruiting participants. Contact the research team at mohamed.elsawaf@dentistry.cu.edu.eg for enrollment information.
Where is the NCT06707909 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT06707909 clinical trial?
NCT06707909 is sponsored by Cairo University. The trial plans to enroll 20 participants.