The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
NCT ID: NCT06707909
Last Updated: 2025-02-05
Study Results
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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RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2025-02-15
2025-11-24
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Menaquinone
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohamed Hussien Mohamed Elsawaf
Principal Investigator
Locations
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Cairo
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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mohamed Khashaba, Professor
Role: CONTACT
Facility Contacts
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Other Identifiers
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CEBD-CU
Identifier Type: -
Identifier Source: org_study_id
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