Osteogenic Action of a Medical Device Based on Beta-tricalcium Phosphate (BTCP)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMario Pérez Sayáns
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Medical device: beta-tricalcium phosphate
- Bovine Hydroxyapatite
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mario Pérez Sayáns
Lead sponsor
University of Santiago de Compostela
Sponsor institution
Universidad de Murcia
Collaborator
Nueva Galimplant SLU
Collaborator
Source ClinicalTrials.gov