The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Menaquinone.
- Кому может быть актуально
- Состояния в реестре: Socket Preservation. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trail
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Menaquinone
the socket will be filled with crushed capsule of vitamin k2 menaquinone in study group
Первичные конечные точки
- Marginal bone loss [Срок оценки: baseline and 4 month after extraction]
Вторичные конечные точки (2)
- Primary stability [Срок оценки: at time of implant placment]
- amount of new bone formation [Срок оценки: baseline and 4 month after extraction]
Критерии участия
Inclusion Criteria:• Age > 18 years without other age or gender restrictions.
- Patients requiring extraction of mandibular single-rooted teeth.
Критерии исключения
- • 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Cairo — Cairo
Идентификаторы
NCT: NCT06707909 · CEBD-CU