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

NCT06935747 | Not Yet Recruiting Phase 4

• 1 other identifier: BTCP2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Loss; Regenerative Inflammation; Third Molars Extraction

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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)

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

Secondary Outcomes (5)

• Pain levels through visual analog scale

  24 hours, 48 hours, 72 hours, and 7 days

• Clinical Inflammation evaluating by presence/absence

  24 hours, 48 hours, 72 hours, and 7 days

• Healing measured by healing index

  24 hours, 48 hours, 72 hours, and 7 days

• Post-surgical complications evaluated by presence or absense

  24 hours, 48 hours, 72 hours, and 7 days

• Oral Health-related Quality of Life measured by OHIP-14 test

  24 hours, 48 hours, 72 hours, and 7 days

Study Arms (2)

BTCP Group

EXPERIMENTAL

The experimental BTCP group includes participants who will receive BTCP after the extraction of an impacted mandibular third molar to test its osteogenic properties. BTCP is prepared according to the manufacturer's instructions, initially by immersing it in sterile saline solution. It is applied to the socket after extraction using specialized instruments and is compared with a control group that receives Bio-Oss, a standard xenograft material. Patients in the experimental group receive postoperative medication, including antibiotics and pain management treatment. Follow-up evaluations assess pain, inflammation, complications, and bone regeneration through radiological assessment. Objective: To evaluate the efficacy of BTCP in bone regeneration compared to the control.

Combination Product: Medical device: beta-tricalcium phosphate

Control group

ACTIVE COMPARATOR

The control group serves as the active comparator to the BTCP experimental group in this study. Participants undergo the same impacted mandibular third molar extraction procedures as those in the experimental group, but receive a standard material, Bio-Oss, instead of BTCP. Bio-Oss, a widely used xenograft material in dental surgeries, serves as the reference due to its osteoconductive properties. It is applied to the socket after extraction using specialized instruments and acts as a benchmark for comparing the efficacy of BTCP. Patients in the control group receive postoperative medication according to the study protocol, including antibiotics and pain management treatment. Follow-up assessments evaluate pain, inflammation, complications, and bone regeneration through radiological evaluation.

Other: Bovine Hydroxyapatite

Interventions

Medical device: beta-tricalcium phosphate COMBINATION_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.

BTCP Group

Bovine Hydroxyapatite OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Pérez Sayáns: lead
• Universidad de Murcia: collaborator
• Nueva Galimplant SLU: collaborator

Study Sites (2)

Universidade de Santiago de Compostela

Santiago de Compostela, A Coruña, 15705, Spain

Location

University of Murcia

Murcia, Murcia, Spain

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Fabio Camacho Alonso, phD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

• Abel García García, phD

  Universidade de Santiago de Compostela

  STUDY CHAIR

Central Study Contacts

MARIO PEREZ-SAYANS GARCIA, PHD, PHD

CONTACT

+34626233504; mario.perez@usc.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)