NCT06935747

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

Clinical Study to Analyze the Osteogenic Action of a Beta-tricalcium Phosphate-based Product in Bone Regeneration After the Extraction of Impacted Mandibular Third Molars.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mario Pérez Sayáns · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Bone Loss
• Regenerative Inflammation
• Third Molars Extraction

Interventions

Type	Name	Description
COMBINATION_PRODUCT	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.
OTHER	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-03-01
• Completion: 2026-07-01
• First posted: 2025-04-20
• Last updated: 2025-04-24

Locations

2 sites across 1 country: Spain