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

Phase 4Not Yet RecruitingNCT06935747

Mario Pérez Sayáns30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bone Loss Regenerative Inflammation Third Molars Extraction

Interventions

Medical device: beta-tricalcium phosphateCOMBINATION_PRODUCT

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 HydroxyapatiteOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Universidade de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

University of Murcia

Murcia, Murcia, Spain

Outcomes

Primary Outcomes

Bone Regeneration_Reduction in radiolucent volume

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.

Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months

Bone Regeneration_bone volume

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

Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months

Bone Regeneration_bone density

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.

Time frame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months

Bone Regeneration_Fractal dimension

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)

Central Contacts

MARIO PEREZ-SAYANS GARCIA, PHD, PHD

CONTACT

+34626233504 mario.perez@usc.es

Data from ClinicalTrials.gov

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Secondary Outcomes

Pain levels through visual analog scale

Assessment of pain experienced by participants using a visual analog scale (VAS) at various time points post-extraction. It comprehends values between 0-10, where 10 is the worst situation.