Osteogenic Action of a Medical Device Based on Beta-tricalcium Phosphate (BTCP)

Официальное название

Clinical Study to Analyze the Osteogenic Action of a Beta-tricalcium Phosphate-based Product in Bone Regeneration After the Extraction of Impacted Mandibular Third Molars.

Обзор

The general objective of this split-mouth study is to analyze the osteogenic action of BTCP during the bone regeneration process following the extraction of impacted mandibular third molars.

Подробное описание

The proposed protocol is a multicenter clinical trial aimed at analyzing the osteogenic action of a medical device based on beta-tricalcium phosphate (hereinafter BTCP) in the bone regeneration process following the extraction of impacted mandibular third molars. The specific objectives of the study include a comparative analysis of clinical and radiological variables between a control group and a study group.

Inclusion criteria for study subjects include being of legal age, providing informed consent, and requiring the extraction of both impacted mandibular third molars, among others. Exclusion criteria include the presence of severe mental disorders or medical contraindications for tooth extraction.

The study involves a total of 60 third molars from 30 patients, divided into a control group and a study group. Data will be collected regarding patient demographics, the surgical procedure, and the bone regeneration assessment.

The surgical procedure involves selecting patients with similarly complex third molars, followed by tooth extraction and the placement of BTCP in the study group or a standard material in the control group. Clinical follow-up will be conducted during the first 7 days, and radiological follow-up will take place over the following 6 months to evaluate bone regeneration.

Patients will receive compensation for their participation in the study, which includes medical consultations, phone follow-ups, examination time, completion of questionnaires, and training in self-assessment.

Вмешательства

• Комбинированный продукт Medical device: beta-tricalcium phosphate
  The description of the intervention for BTCP in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. BTCP is indicated for the treatment of segmental and cavitary bone loss, aesthetic repairs, and bone augmentations (such as inlay or onlay grafts); for filling dental alveolar bone; for dental implant placement; and for the stabilization of osteotomies and prostheses in dentistry.
• Другое Bovine Hydroxyapatite
  The intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties.

Первичные конечные точки

• Bone Regeneration_Reduction in radiolucent volume [Срок оценки: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months]
• Bone Regeneration_bone volume [Срок оценки: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months]
• Bone Regeneration_bone density [Срок оценки: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months]
• Bone Regeneration_Fractal dimension [Срок оценки: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months]

Вторичные конечные точки (5)

• Pain levels through visual analog scale [Срок оценки: 24 hours, 48 hours, 72 hours, and 7 days]
• Clinical Inflammation evaluating by presence/absence [Срок оценки: 24 hours, 48 hours, 72 hours, and 7 days]
• Healing measured by healing index [Срок оценки: 24 hours, 48 hours, 72 hours, and 7 days]
• Post-surgical complications evaluated by presence or absense [Срок оценки: 24 hours, 48 hours, 72 hours, and 7 days]
• Oral Health-related Quality of Life measured by OHIP-14 test [Срок оценки: 24 hours, 48 hours, 72 hours, and 7 days]

Критерии участия

Критерии включения

• Patients must be of legal age, generally defined as 18 years or older, to be able to provide adequate informed consent and understand the risks and benefits of the procedure.
• Informed Consent: Patients must be willing to provide written informed consent to participate in the study, indicating their understanding and acceptance of the associated procedures and risks.
• Need for Extraction of Impacted Mandibular Third Molars: Patients must require the extraction of both impacted mandibular third molars to be eligible for the study.
• Similar Complexity of Impacted Third Molars: The impacted mandibular third molars must present similar complexity for extraction on both sides of the jaw, to ensure a fair comparison between the study groups.
• Absence of Medical Contraindications for Oral Surgical Procedures: Patients must not have significant medical contraindications that would prevent oral surgical procedures, such as clotting disorders, uncontrolled systemic diseases, or a history of severe infections.

Критерии исключения

• Severe Mental Disorders: Patients with severe mental disorders that may affect their ability to understand and follow study instructions may be excluded due to concerns about their capacity to provide valid informed consent and follow the study protocol.
• Contraindications for Dental Extractions: Patients with specific contraindications for dental extraction, such as a history of osteonecrosis of the jaws or serious complications associated with previous dental procedures, may be excluded for safety reasons.
• Patients under the age of 18 will not be eligible to participate in the study due to ethical and legal concerns related to obtaining informed consent and the ability to understand the risks and benefits of the study.

Withdrawal from the Study:

-If a patient experiences severe complications during the study, such as severe postoperative infections, severe allergic reactions, or any other adverse event that may jeopardize their health, they will be considered for withdrawal from the study to ensure their well-being. Additionally, if a patient decides to voluntarily withdraw from the study at any time, their decision will be respected, and appropriate medical care will be provided as needed.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 2 центра

• Universidade de Santiago de Compostela — Santiago de Compostela
• University of Murcia — Murcia

Идентификаторы

NCT: NCT06935747 · BTCP2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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