Status:
NOT_YET_RECRUITING
Osteogenic Action of a Medical Device Based on Beta-tricalcium Phosphate (BTCP)
Lead Sponsor:
Mario Pérez Sayáns
Collaborating Sponsors:
Universidad de Murcia
Nueva Galimplant SLU
Conditions:
Bone Loss
Regenerative Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
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 proces...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06935747
Start Date
July 1 2025
End Date
July 1 2026
Last Update
April 24 2025
Active Locations (2)
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1
Universidade de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15705
2
University of Murcia
Murcia, Murcia, Spain