Polyphosphate (PolyP) for alveolar cleft repair: study protocol for a pilot randomized controlled trial

Abstract Objective Bone grafting is an important surgical procedure to restore missing bone in patients with alveolar cleft lip/palate, aiming stabilize either sides of the maxillary segments by inducing new formation, and bilateral cases also pre-maxilla. Polyphosphate (PolyP), a physiological polymer composed orthophosphate units linked together high-energy phosphate bonds, naturally existing compound platelets which, when complexed calcium as Ca-polyP microparticles (Ca-polyP MPs), was proven have osteoinductive properties preclinical studies. Aim To evaluate feasibility, safety, osteoinductivity MPs bone-inducing graft material humans. Methods This prospective non-blinded first-in-man clinical pilot study shall consist 8 13 years or older feasibility safety Ca-PolyP material. Patients will receive only combination biphasic (BCP) substitute carrier. During trial, participants be investigated closely for parameters using radiographic imaging, regular blood tests, physical examinations. After 6 months, hollow drill used prepare implantation site obtain biopsy. The imaging evaluation; biopsy processed histological/histomorphometric evaluation formation. Discussion evaluating polyP well potential regenerative capacity model. Trial registration Indonesian Registry INA-EW74C1N . Registered on 12 June 2020