JMIR Publications

ABSTRACT

Background:

In alveolar cleft reconstructions, inorganic bone substitutes such as osteoconductive biphasic calcium phosphate (BCP) may serve as alternatives for iliac crest-derived autograft bone, since the latter are associated with chronic pain and donor site morbidity. To add osteoinductivity, the locally harvested buccal fat pad will be mechanically fractionated to generate microfragmented fat (MFAT), having high regenerative capacity due to high pericyte and MSC content and a preserved perivascular niche.

Objective:

This study aims to evaluate the feasibility and safety of the BCP-MFAT combination.

Methods:

Eight alveolar cleft patients will be included in this prospective non-blinded first-in-human clinical study. MFAT will be prepared intraoperatively from the patient’s own buccal fat pad. Radiographic imaging will be performed prior to surgery, and at regular intervals after placement of the BCP-MFAT combination in the alveolar cleft. Similarly, regular blood tests and physical examinations will be conducted. The radiographic imaging will be used for clinical evaluation, while biopsies obtained after 6 months with a trephine drill used to prepare the implantation site will be assessed with histological and histomorphometric analyses.

Results:

As of September 2022, we enrolled 8 patients. Data collection started on 1 November 2019 and is expected to end on 1 November 2022. We expect the results of alveolar cleft reconstruction with a combination of Buccal Fat Pad (BFP) and BCP can be a safe alternative to the conventional alveolar graft method. In addition, we expect that the use of this graft material shall reduce the postoperative complications and enhance patient recovery after the procedure.

Conclusions:

In this first-in-human study, not only safety but also the regenerative potential of the BCP-MFAT combination will be evaluated in the alveolar cleft model. Clinical Trial: Indonesian trial registry [INA-EW74C1N]