Clinical trial NCT06707909: The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
Official title: The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Socket Preservation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Marginal bone loss
timeFrame: baseline and 4 month after extraction
Secondary outcomes:
measure: Primary stability
timeFrame: at time of implant placment
measure: amount of new bone formation
timeFrame: baseline and 4 month after extraction
Other outcomes:
measure: Secondary stability
timeFrame: 4 month post-implant placement
Locations:
city: Cairo
country: Egypt
facility: Cairo
Study officials:
References: