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

Launched by MARIO PÉREZ SAYÁNS · Apr 13, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a medical device made from a material called beta-tricalcium phosphate (BTCP) to see how well it helps with bone healing after the removal of impacted wisdom teeth, also known as third molars. The study aims to understand how this device can support the body’s natural process of bone regeneration in people who need these teeth extracted.

To participate in the trial, individuals must be at least 18 years old and need to have both impacted third molars removed. They should be in good health overall, without any serious medical conditions that could complicate the surgery. Participants will have their extractions done on both sides of the jaw, allowing researchers to compare the effects of the BTCP device directly. If someone experiences serious complications during the study or chooses to leave, their safety and well-being will always come first.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.