Clinical Trials in Spain / NCT06935747
Starting soon
Phase 4
Osteogenic Action of a Medical Device Based on Beta-tricalcium Phosphate (BTCP)
NCT06935747 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Bone LossRegenerative InflammationThird Molars Extraction
Investigational drug(s) / intervention(s)
Medical device: beta-tricalcium phosphateBovine Hydroxyapatite
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.
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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Bone Regeneration_Reduction in radiolucent volume — A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Reduction in radiolucent volume within the extraction socket, indicating new bone formation (Hounsfield unit (HU)). High values mean more radiopacity and better regeneration. - Bone Regeneration_bone volume — A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone volume within the extraction site over time (mm3). The increase in bone volume means better regeneration - Bone Regeneration_bone density — A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Changes in bone density within the regenerated bone tissue (Hounsfield unit (HU)) High values mean more radiopacity and better regeneration. - Bone Regeneration_Fractal dimension — A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone morphology within the extraction site over time analyzing the fractal dimension (FD) FD can vary between 1 and 2, with 1 being a very simple fractal dimension (such as a straight line) and 2 being a more complex fractal dimension (such as a completely irregular surface)
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Universidade de Santiago de Compostela | Santiago de Compostela | A Coruña | |
| University of Murcia | Murcia | Murcia |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06935747 on ClinicalTrials.gov ↗ ← All trials in Spain