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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Medical device: beta-tricalcium phosphate
Combination productThe 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
Other interventionThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: BTCP GroupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 months3
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 months4
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)
Time frame
A) Immediately after extraction B) 1 month. C) 3 months. D) 6 monthsSecondary outcomes
1
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.
Time frame
24 hours, 48 hours, 72 hours, and 7 days2
Clinical Inflammation evaluating by presence/absence
Evaluation of postoperative inflammation around the extraction site using clinical examination and assessment tools (presence/absence). The presence of inflammation means the worst prognosis.
Time frame
24 hours, 48 hours, 72 hours, and 7 days3
Healing measured by healing index
The healing progress will be assessed using the Healing Index (HI) developed by Hamzani \& Chaushu (2018) and Landry (1988). The HI score ranges from 0 to 5, where 0 indicates poor healing and 5 indicates excellent healing. To ensure consistency and reliability in the assessment of healing, two independent researchers will evaluate the healing progress for all participants. The level of agreement between the researchers will be assessed using Cohen's Kappa index (Mandrekar, 2011). A Cohen's Kappa index value of 0.91 was achieved for the assessment of inflammation level, indicating a high degree of agreement. Similarly, agreement levels exceeding 0.90 were obtained across all HI levels, demonstrating a high level of concordance in the assessment of healing progress.
Time frame
24 hours, 48 hours, 72 hours, and 7 days4
Post-surgical complications evaluated by presence or absense
Monitoring and recording of any complications following the extraction procedure, such as alveolitis, trismus, infection, and hematoma (presence/absence). The presence of complications is related to a worse prognosis.
Time frame
24 hours, 48 hours, 72 hours, and 7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mario Pérez Sayáns
Lead sponsor
University of Santiago de Compostela
Sponsor institution
Universidad de Murcia
Collaborator
Nueva Galimplant SLU
Collaborator
Source ClinicalTrials.gov
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