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

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

The Epidemiology, treatment, and complication of ameloblastoma in East-Indonesia: 6 years retrospective study.

BACKGROUND: Ameloblastoma is a neoplasm classified as a benign epithelial odontogenic tumor of the jaws, grow slowly and are locally invasive. The aim of the present study was to investigate the incidence, treatment, and complication of patients with ameloblastoma in East-Indonesia during six years retrospective study. MATERIAL AND METHODS: This retrospective study included 84 patients who were diagnosed with ameloblastoma from 2011 to 2016. There were 56 patients with treatment data available. Data from each patient, including gender, age, histologic type, the size of the tumor, radiologic form, tumor location, type of treatment, and complication were reviewed and analyzed retrospectively. RESULTS: Fourteen patients were diagnosed with unicystic ameloblastoma (25%), thirty two patients with multicystic follicular ameloblastoma (57%) and ten patients with an unspecified multicystic ameloblastoma (18%). A total of about 35 patients were treated conservatively (62.5%) and 21 patients were treated radically (37.5%). Swelling was present as a pre-operative complication in all 56 cases (100%). There were no complaints concerning speech. CONCLUSIONS: The majority findings of the histologic type were multicystic ameloblastoma and their location were in the mandible. Most ameloblastoma were treated conservatively and reconstructions were made with only titanium plates and not bone graft.

TGFß3 / SfaN1 gene variant and the risk factor of nonsyndromic cleft palate only among Indonesian patients.

Non-syndromic cleft palate only (NS CPO) is one of the most common congenital malformations that affect between 1 in 1000 - 2500 live births worldwide. The etiopathogenesis of clefts including NS CPO has been widely studied but is still poorly understood. NS CPO is considered to be a genetically complex, multifactorial disease. Based on several studies, mutations of TGFß3 gene emerged as the strong candidate gene associated with NS CPO. The purpose of this study was to analyze the relationship between the TGFß3 / SfaN1 gene variant and the risk of NS CPO in Indonesian patients. This study was case control design using samples from 31 NS CPO subjects and 35 control subjects. DNA was extracted from venous blood and the segment of TGFß3 gene/ SfaN1 were amplified by using polymerase chain reaction (PCR) technique, then digestion products by SfaN1 restriction enzyme which can detect locus of gene variant / polymorphism from restriction fragment length polymorphisms (RFLP) method were evaluated. The results indicated that the gene variant as substitution of base G into A was identified in TGFß3 gene and the frequency of heterozygous mutant GA genotype was 63,6% in NS CPO subjects and 36,4% in control subjects. The frequency of heterozygous mutant GA genotype was associated with increased risk of NS CPO (odds ratio (OR) = 2,260, 95% CI = 0,592 - 8,625). In conclusion, TGFß3 gene / SfaN1 polymorphism can be considered as the risk factor associated with NS CPO in Indonesian patients.