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Microfragmented Fat and Biphasic Calcium Phosphates for Alveolar Cleft Repair: Protocol for a Prospective,
Diandra Sabrina Natsir Kalla1,2, Salem Alkaabi1,3, Abul Fauzi4
1Department of Oral and Maxillofacial Surgery/Oral Pathology, Amsterdam University Medical Centers and Academic Centre for Dentistry Amsterdam, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences, Amsterdam, Netherlands.
This study assesses the safety and efficacy of combining biphasic calcium phosphates (BCP) with microfragmented fat (MFAT) for alveolar cleft reconstruction. The BCP-MFAT combination shows potential for bone regeneration, with safety and efficacy evaluated through radiographic and histological analyses.
Area of Science:
- Regenerative Medicine
- Biomaterials Science
- Oral and Maxillofacial Surgery
Background:
- Biphasic calcium phosphates (BCP) are explored as alternatives to autologous bone for alveolar cleft reconstruction.
- Microfragmented fat (MFAT), derived from buccal fat pads, is investigated for its osteoinductive properties.
- Combining BCP with MFAT aims to enhance regenerative capacity, mimicking autologous bone.
Purpose of the Study:
- To evaluate the feasibility and safety of the BCP-MFAT combination in alveolar cleft repair.
- To assess the efficacy of the BCP-MFAT combination using radiographic and histological methods.
- To compare the regenerative potential of BCP-MFAT with traditional autologous bone grafts.
Main Methods:
- A prospective, first-in-human study involving eight patients (≥15 years) with alveolar clefts.
- Intraoperative preparation of autologous MFAT from buccal fat pads.
- Reconstruction of alveolar clefts using the BCP-MFAT combination, followed by 6-month follow-up.
- Safety monitoring via blood tests, physical exams, and recording of adverse events (AEs/SAEs).
- Efficacy assessment through pre-operative and post-operative radiographic imaging (Bergland scale) and histological/histomorphometric analysis of biopsies.
Main Results:
- The study is currently in the follow-up stage, with recruitment completed.
- Primary outcome is safety at 6 months, monitored for SAEs.
- Efficacy will be determined by radiographic bone grading and quantitative histomorphometry (bone volume, osteoid, graft, osteoclasts).
Conclusions:
- This first-in-human study will determine the safety and regenerative potential of the BCP-MFAT combination in alveolar clefts.
- Safety will be established if SAEs do not occur or if AEs are comparable to standard care and manageable.
- Histological and radiographic assessments will provide insights into the bone regeneration capacity of this novel biomaterial combination.
