The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Menaquinone.
- Who it may be relevant to
- Registry conditions: Socket Preservation. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trail
Overview
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.
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.
Interventions
- Drug Menaquinone
the socket will be filled with crushed capsule of vitamin k2 menaquinone in study group
Primary outcome measures
- Marginal bone loss [Time frame: baseline and 4 month after extraction]
Secondary outcome measures (2)
- Primary stability [Time frame: at time of implant placment]
- amount of new bone formation [Time frame: baseline and 4 month after extraction]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo — Cairo
Identifiers
NCT: NCT06707909 · CEBD-CU