The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trail
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Marginal bone loss
研究概览
简要总结
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.
详细描述
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.
- Interventions
- Patients were randomly divided into two equal groups.
In both groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years without other age or gender restrictions.
- •Patients requiring extraction of mandibular single-rooted teeth.
排除标准
- •• 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.
研究组 & 干预措施
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.
干预措施: Menaquinone (Drug)
结局指标
主要结局
Marginal bone loss
时间窗: baseline and 4 month after extraction
At the time of extraction, CBCT imaging will provide baseline data on the initial bone structure This baseline measurement serves as a reference point for evaluating any subsequent changes in bone density and morphology. After four months, another CBCT scan will be conducted to assess the amount of marginal bone loss that has occurred since the initial extraction. By comparing the post-extraction CBCT images with those taken after four months, researchers can quantify any changes in bone volume and identify any areas of concern related to bone resorption. The unit of measurement for the primary outcome, vertical bone change (socket height), is millimeters (mm).
次要结局
- Primary stability(at time of implant placment)
- amount of new bone formation(baseline and 4 month after extraction)
研究者
Mohamed Hussien Mohamed Elsawaf
Principal Investigator
Cairo University