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BACKGROUND: Biphasic calcium phosphates (BCP) may serve as off-the-shelf alternatives for iliac crest-derived autologous bone in alveolar cleft reconstructions. To add osteoinductivity to the osteoconductive BCPs to achieve similar regenerative capacity as autologous bone, a locally harvested buccal fat pad will be mechanically fractionated to generate microfragmented fat (MFAT), which has been shown to have high regenerative capacity due to high pericyte and mesenchymal stem cell content and a preserved perivascular niche. OBJECTIVE: Our primary objectives will be to assess the feasibility and safety of the BCP-MFAT combination. The secondary objective will be efficacy, which will be evaluated using radiographic imaging and histological and histomorphometric evaluation of biopsies taken 6 months postoperatively, concomitant with dental implant placement. METHODS: Eight patients with alveolar cleft (≥15 years) will be included in this prospective, nonblinded, first-in-human clinical study. MFAT will be prepared intraoperatively from the patient's own buccal fat pad. Regular blood tests and physical examinations will be conducted, and any adverse events (AEs) or serious EAs (SAEs) will be meticulously recorded. Radiographic imaging will be performed prior to surgery and at regular intervals after reconstruction of the alveolar cleft with the BCP-MFAT combination. Biopsies obtained after 6 months with a trephine drill used to prepare the implantation site will be assessed with histological and histomorphometric analyses after methylmethacrylate embedding and sectioning. RESULTS: The primary outcome parameter will be safety after 6 months' follow-up, as monitored closely using possible occurrences of SAEs based on radiographic imaging, blood tests, and physical examinations. For efficacy, radiographic imaging will be used for clinical grading of the bone construct using the Bergland scale. In addition, bone parameters such as bone volume, osteoid volume, graft volume, and number of osteoclasts will be histomorphometrically quantified. Recruitment started in November 2019, and the trial is currently in the follow-up stage. This protocol's current version is 1.0, dated September 15, 2019. CONCLUSIONS: In this first-in-human study, not only safety but also the histologically and radiographically assessed regenerative potential of the BCP-MFAT combination will be evaluated in an alveolar cleft model. When an SAE occurs, it will be concluded that the BCP-MFAT combination is not yet safe in the current setting. Regarding AEs, if they do not occur at a higher frequency than that in patients treated with standard care (autologous bone) or can be resolved by noninvasive conventional methods (eg, with analgesics or antibiotics), the BCP-MFAT combination will be considered safe. In all other cases, the BCP-MFAT combination will not yet be considered safe. TRIAL REGISTRATION: Indonesia Clinical Trial Registry INA-EW74C1N; https://tinyurl.com/28tnrr64. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42371.
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BACKGROUND: Dentigerous cysts are slow-growing, asymptomatic lesions that typically form around the crowns of impacted teeth. They are not detected until they start to harm the tissues around the teeth. AIM: The present study aimed to describe surgical techniques for treating dentigerous cysts associated with ectopic teeth. CASES: Three patients with dentigerous cysts associated with ectopic teeth, their surgical approaches, and the supporting literature are presented herein. In two cases, the surgical technique used was intra-oral, and in one case was extra-oral. Under general anesthesia, dentigerous cyst enucleation and ectopic tooth removal were carried out. DISCUSSION: In the present study, the ectopic tooth cases were all linked to dentigerous cysts. Enucleation or marsupialization treatments could be used to treat dentigerous cysts. Enucleation with the removal of the impacted tooth is the preferred treatment for dentigerous cysts. CONCLUSION: To perform minimally invasive surgery, the position of the ectopic teeth, the accessibility of the surgical site, the degree of bone reduction, and the simplicity of instrumentation should all be considered.
RESUMEN
Background: Diagnosis of jaw cysts is challenging in general dental practice, and most cases are incidentally discovered through routine dental radiography. The aim of this study was to examine the epidemiology and treatment of odontogenic and non-odontogenic cysts to better understand the status of these lesions in populations in South Sulawesi, Indonesia. Material and Methods: This retrospective study was conducted on patients treated at four different hospitals in Makassar between January 2011 and June 2017. Patients diagnosed as having odontogenic or non-odontogenic cysts were included in the study. Information on variables such as sex, age, histopathological, and anatomical distributions was collected. Statistical analyses were performed using an independent T-test and the Pearson chi-square test (p< 0.05). Results: A total of 173 samples were collected, of which only 60 were histopathologically analyzed. The patients' mean age was 30.3 years. The cysts occurred more frequently in women and in the anterior maxilla, followed by the posterior mandible. The radicular cyst was the most prevalent type, followed by the dentigerous cyst. Most cysts were treated with enucleation. Of the patients, 72.8% were followed up, of whom 3.2% had a recurrence and only 19.1% had complaints of clinical symptoms. Conclusions: Our findings indicate that odontogenic and non-odontogenic cysts widely vary in terms of incidence, with some exhibiting a predilection for specific ages and sites and specific sex. Knowledge of these factors could be useful for both clinicians and pathologists in the diagnosis and choice of the appropriate treatment plan. Key words:Cyst, epidemiology, odontogenic, non-odontogenic, treatment.
RESUMEN
BACKGROUND: Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or in combination with BCP, in a first-in-human clinical trial. METHODS: This single-blinded, parallel, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13-34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was 6 months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations. Osteoinductivity evaluation using histomorphometric analysis of biopsies was not possible due to COVID restrictions. RESULTS: Due to surgical and feasibility reasons, eventually, only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day 180). Three out of eight were unable to reach the hospital due to COVID-19 restrictions. One patient decided not to continue with the study. None of the patients showed any allergic reactions or any remarkable local or systematic side effects. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients who got the BCP/Ca-polyP MPs combination had scores ranging from I to III. CONCLUSIONS: Our results indicate that Ca-polyP MPs and the BCP/Ca-polyP MPs combination appear to be safe graft materials; however, in the current setting, Ca-polyP MPs alone may not be a sufficiently stable defect-filling scaffold to be used in alveolar cleft repair. TRIAL REGISTRATION: Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019 .
