Evaluation of Type, Nature, and Prevalence of Common Oral Pathology Lesions Involving Periodontium and Implant in Patients of Tertiary Level Dental Hospital in Hazaribagh City, Jharkhand.

Background: Evaluation of type, nature, and prevalence of common oral pathology lesions involving periodontium and implant in patients of tertiary level dental hospital in Hazaribagh City, Jharkhand. Materials and Methods: A total of 2467 people were requested to take part in the oral examination. The current study cohort was made up of the 62.4% of the initial subgroup who participated in the clinical oral examination and granted their agreement for the use of the data. Between January 2023 and June 2023, the clinical oral examination was completed. Results: No changes were observed in 89.6% of study participants. 88.2% males had no changes while 90.4% females had no changes. Normal variations were observed in 3.4% of study participants. 4.3% males had normal variations while 2.7% females had normal variations. Infectious oral pathology was observed in 3.3% of study participants. 2.4% males had infectious oral pathology while 3.2% females had infectious oral pathology Ulcerative lesions were observed in 4.1% of study participants. 3.6% males had ulcerative lesions while 2.4% females had ulcerative lesions. White lesions were observed in 6.7% of study participants. 8.2% males had white lesions while 5.6% females had white lesions. Conclusion: This study provided a detailed evaluation of type, nature, and prevalence of different oral pathology lesions focusing on periodontium and implant.

A Rare Case of Schwannoma of the Right Greater Palatine Nerve in a 17-Year-Old Female Patient.

Schwannomas are not uncommon in the maxillofacial region; however, those with intraoral localization and, in particular, the hard palate are among the least frequently described. In the current case report, we present a 17-year-old girl with a histologically verified schwannoma of the hard palate on the right, originating from the right greater palatine nerve. In her case, despite the lysis of the palatine bone from the tumor compression, the disease is asymptomatic, causing only a weak sensation of local discomfort. The lesion was removed surgically under general anesthesia and the resulting defect of the palatal mucosa was compensated by plastic reconstruction with a lingual mucosal flap on a posterior feeding base. The recovery period was uneventful.

Oral-Gut-Estrobolome Axis May Exert a Selective Impact on Oral Cancer.

A subset of bacterial species that holds genes encoding for ß-glucuronidase and ß-galactosidase, enzymes involved in the metabolism of conjugated estrogens, is called the "estrobolome." There is an emerging interest embracing this concept, as it may exert a selective impact on a number of pathologies, including oral cancer. Although the estrobolome bacteria are typically part of the gut microbiota, recent experimental pieces of evidence have suggested a crosstalk among oral and gut microbiota. In fact, several oral bacterial species are well represented also in the gut microbiota, and these microbes can effectively induce the estrobolome activation. The main pathways used for activating the estrobolome are based on the induction of the expression patterns for 2 bacterial enzymes: ß-glucuronidase and aromatase, both involved in the increase of estrogen released in the bloodstream and consequently in the salivary compartment. Mechanistically, high estrogen availability in saliva is responsible for an increase in oral cancer risk for different reasons: briefly, 1) estrogens directly exert biological and metabolic effects on oral mucosa cells; 2) they can modulate the pathological profile of some bacteria, somewhere associated with neoplastic processes (i.e., Fusobacterium spp., Parvimonas ssp.); and 3) some oral bacteria are able to convert estrogens into carcinogenic metabolites, such as 4-hydroxyestrone and 16α-hydroxyestrone (16α-OHE), and can also promote local and systemic inflammation. Nowadays, only a small number of scientific studies have taken into consideration the potential correlations among oral dysbiosis, alterations of the gut estrobolome, and some hormone-dependent cancers: this lack of attention on such a promising topic could be a bias affecting the full understanding of the pathogenesis of several estrogen-related oral pathologies. In our article, we have speculated on the activity of an oral-gut-estrobolome axis, capable of synergizing these 2 important microbiotas, shedding light on a pilot hypothesis requiring further research.

Bacteriome and mycobiome dysbiosis in oral mucosal dysplasia and oral cancer.

It has long been considered that the oral microbiome is tightly connected to oral health and that dysbiotic changes can be detrimental to the occurrence and progression of dysplastic oral mucosal lesions or oral cancer. Improved understanding of the concepts of microbial dysbiosis together with advances in high-throughput molecular sequencing of these pathologies have charted in greater microbiological detail the nature of their clinical state. This review discusses the bacteriome and mycobiome associated with oral mucosal lesions, oral candidiasis, and oral squamous cell carcinoma, aiming to delineate the information available to date in pursuit of advancing diagnostic and prognostic utilities for oral medicine.

Tetraspanin CD82 Correlates with and May Regulate S100A7 Expression in Oral Cancer.

Many metastatic cancers with poor prognoses correlate to downregulated CD82, but exceptions exist. Understanding the context of this correlation is essential to CD82 as a prognostic biomarker and therapeutic target. Oral squamous cell carcinoma (OSCC) constitutes over 90% of oral cancer. We aimed to uncover the function and mechanism of CD82 in OSCC. We investigated CD82 in human OSCC cell lines, tissues, and healthy controls using the CRISPR-Cas9 gene knockout, transcriptomics, proteomics, etc. CD82 expression is elevated in CAL 27 cells. Knockout CD82 altered over 300 genes and proteins and inhibited cell migration. Furthermore, CD82 expression correlates with S100 proteins in CAL 27, CD82KO, SCC-25, and S-G cells and some OSCC tissues. The 37-50 kDa CD82 protein in CAL 27 cells is upregulated, glycosylated, and truncated. CD82 correlates with S100 proteins and may regulate their expression and cell migration. The truncated CD82 explains the invasive metastasis and poor outcome of the CAL 27 donor. OSCC with upregulated truncated CD82 and S100A7 may represent a distinct subtype with a poor prognosis. Differing alternatives from wild-type CD82 may elucidate the contradictory functions and pave the way for CD82 as a prognostic biomarker and therapeutic target.

Preservation of the inferior alveolar vasculonervous bundle in mandibular resective therapies: systematic review and report of two cases

Background: Segmental surgical resection is a frequently indicated procedure to treat aggressive mandibular tumors. One of the most important complications derived from this technique is permanent paresthesia of the inferior alveolar nerve (IAN), which significantly affects the quality of life of patients who experience it. This could be avoided through maneuvers that preserve the IAN. The objective of this paper is to review the main techniques for IAN preservation and to present 2 cases with the technique used by the author. Material and Methods: A systematic review was performed according to the PRISMA guidelines, apropos of two clinical cases reported in this study. The MEDLINE/PubMed and Scopus databases were searched. Several variables were considered and are presented in detail in the form of tables and figures. In addition, 2 case reports with NAI preservation techniques are presented. Results: 13 articles were finally obtained for analysis. 127 patients were evaluated, reporting mandibular resections associated with various pathologies. Various surgical techniques were used, all with the same goal of maintaining the IAN. In most of the patients, the maintenance of sensitivity was achieved, which was verified with different methods. Conclusions: Preservation of the IAN in maxillofacial surgical procedures where surgical resection of the mandibular bone has been performed is an alternative that has demonstrated successful results in terms of reducing postoperative sequelae and is currently positioned as a necessary and feasible procedure. (AU)

Root Cause Analysis: Unraveling Common Laboratory Challenges.

Diverse errors occur in a pathology laboratory and manual mistakes are the most common. There are various advancements to replace manual procedures with digitized automation techniques. Guidelines and protocols are available to run a standard pathology laboratory. But, even with such attempts to reinforce and strengthen the protocols, the complete elimination of errors is yet not possible. Root cause analysis (RCA) is the best way forward to develop an error-free laboratory, In this review, the importance of RCA, common errors taking place in laboratories, methods to carry out RCA, and its effectiveness are discussed in detail. The review also highlights the potential of RCA to provide long-term quality improvement and efficient laboratory management.

Gingival squamous cell carcinoma in 2 lions under managed care.

Neoplasia is one of the main causes of euthanasia in geriatric captive nondomestic felids. However, few studies have examined oral tumors in these animals. We describe here the clinicopathologic features of gingival squamous cell carcinoma (SCC) in 2 lions (Panthera leo) from separate zoologic collections. In both cases, the lions had a history of sialorrhea, bloody oral discharge, and anorexia. Autopsy findings in both lions were similar and were characterized by poorly circumscribed, friable, and bloody gingival masses with grossly apparent invasion of the mandibular bone; a pathologic fracture was observed in 1 case. Histologically, the masses consisted of poorly circumscribed, unencapsulated, densely cellular proliferations of neoplastic epithelial cells arranged in irregular islands, cords, and anastomosing trabeculae with formation of keratin pearls, which, coupled with positive immunohistochemistry for pancytokeratin, were diagnostic for SCC. Although no metastases were found in either animal, both lions were ultimately euthanized because of poor prognosis.

Elastofibromatous changes in giant cell fibroma and amalgam tattoo: Unusual findings in common oral lesions.

Several cases of elastofibromatous lesion affecting the oral mucosa have been reported. Clinically, these lesions may appear as small exophytic lesions or less often as white lesions. Therefore, fibrous hyperplasia and leukoplakia are not uncommonly considered in clinical differential diagnosis. Microscopically, elastic and fibrous connective tissue deposition is seen. Rarely, elastofibromatous changes can be detected when assessing intraoral lesions, including cysts, salivary gland neoplasms, and epithelial dysplasia. Here we report two oral lesions showing elastofibromatous changes, expanding their clinicopathological spectrum. The first case was a 46-year-old man with a history of asymptomatic nodular lesion on the palate 1 year ago, diagnosed as giant cell fibroma with elastofibromatous changes. The second case was a 79-year-old woman who presented a pigmented and mildly symptomatic lesion on the mandibular alveolar mucosa several months ago, diagnosed as amalgam tattoo associated with elastofibromatous changes.

Lost needle in the oral cavity: can the nightmare be just a bad dream?

OBJECTIVE: The loss of a scalpel or a needle during surgery can threaten the health of the patient and lead to additional costs, and radiographical assistance during surgery has been the only recovery method. This study evaluates the efficacy of a metal detector compared with conventional radiology for recovering a needle lost in the oropharynx during surgery. METHOD: Different fragment sizes of needles normally used in pharyngoplasty were embedded at different locations and depths in a lamb's head. Three experienced and three junior otolaryngologists searched for the needle fragments using a metal detector and conventional radiology. RESULTS: All fragments were found with each method, but the mean searching time was 90 per cent shorter with the metal detector. CONCLUSION: A metal detector can be a useful tool for locating needles that break during ENT surgery, as it requires less time than conventional radiology and avoids exposing patients to radiation.

Revolutionising Quality Management in the Oral Pathology Laboratory: A Deep Dive Into the Six Sigma Methodology.

Six Sigma Foundations is a statistical standard that indicates an exceptionally high level of quality, along with a customer satisfaction management approach that intends to lower error rates and boost process efficiency. The Define, Measure, Analyse, Improve, and Control (DMAIC) approach is a fundamental component of Six Sigma and provides an organised framework for process improvement. In contrast to conventional techniques that are more manual-based, Six Sigma emphasises and focuses on making decisions based on facts and evidence. The key to the success of Six Sigma is its reliance on statistical methods. Advanced tools like Pareto charts, histograms, regression analysis, and fishbone diagrams are used ardently for the benefit of customers and to reduce the overall error rate. To support clinical decision-making, a clinical laboratory's primary responsibility is to generate test results that are accurate, repeatable, fast, and appropriately interpreted. Ensuring desired clinical outcomes must be the ultimate objective. To accomplish this goal, laboratories must prioritise cost-effectiveness while establishing and maintaining quality in all laboratory procedures. The concept of the Lean Six Sigma (LSS) methodology, which mainly centres on efficiency by discerning and eradicating actions or operations that do not provide any benefit to the organisation, is combined with the proposition of Six Sigma, which emphasises data-driven analyses and optimization. The integration of these powerful concepts aids in the overall improvement of the organisations adopting these techniques. This review provides a brief overview of the benefits of the LSS methodology and its implementation in the oral pathology laboratory.

Morphometric variations and nonmetric anatomical traits or anomalies of the primary molar teeth, plus the molars' size thresholds for sex identification.

INTRODUCTION: Morphological and morphometric features of the teeth are of interest to various clinical and academic dental and medical fields including prosthodontics, orthodontics, anatomy and anthropology, pathology, archeology, and forensic dentistry. These have been more or less researched in the case of the permanent dentition. However when it comes to the primary dentition, the literature is scarce and controversial. No study worldwide exists on the cutoff points (thresholds) for sex identification; no study exists on metric or nonmetric traits of deciduous teeth in Iranians. Hence, the aim of the study was to assess both the metric and nonmetric traits of primary molars, as well as their cut-off points for sex identification. METHODS: In this epidemiological cross-sectional study, pretreatment casts of 110 children (51 boys and 59 girls) aged 6 to 12 years were collected. Maxillary and mandibular first and second primary molars were evaluated regarding their metric traits (mesiodistal and buccolingual widths) and 9 nonmetric traits (Accessory cusp on the upper D, Accessory cusp on the lower D, Fifth cusp on the upper E, Carabelli's cusp on the upper E, Protostylid on the lower E, Fifth cusp on the lower E, Sixth cusp on the lower E, Tuberculum intermedium [metaconulid] on the lower E, and Deflecting wrinkle on the lower E). ROC curves were used to identify cut-off points for sex determination as well as the usefulness of metric measurements for this purpose. Data were analyzed using independent-samples and paired-samples t-tests, McNemar, Fisher, and chi-square tests, plus Pearson and Spearman correlation coefficients (α = 0.05). RESULTS: All the primary molars' coronal dimensions (both mesiodistal and buccolingual) were extremely useful for sex identification (ROC curves, all P values ≤ 0.0000099). Especially, the mandibular primary molars (areas under ROC curves [AUCs] between 85.6 and 90.4%, P values ≤ 0.0000006) were more useful than the maxillary ones (AUCs between 80.4 and 83.1%, P values ≤ 0. 0000099). In the mandible, the first primary molar (maximum AUC = 90.4%) was better than the second molar (maximum AUC = 86.0%). The optimum thresholds for sex determination were reported. Sex dimorphism was significant in buccolingual and mesiodistal crown widths of all the primary molars (all P values ≤ 0.000132), but it was seen only in the case of 2 nonmetric traits: Deflecting wrinkle (P = 0.001) and Tuberculum intermedium (metaconulid, P = 0.029) on the lower Es, taking into account the unilateral and bilateral cases. The occurrence of nonmetric traits was symmetrical between the right and left sides (all P values ≥ 0.250). All mesiodistal and two buccolingual molar measurements were as well symmetrical (P > 0.1); however, two buccolingual measurements were asymmetrical: in the case of the maxillary E (P = 0.0002) and mandibular D (P = 0.019). There were three weak-to-moderate correlations between the nonmetric traits of the mandibular second molars (Spearman correlations between 22.7 and 37.5%, P values ≤ 0.045). Up to 6 concurrent nonmetric traits were observed in the sample, with 53.6% of the sample showing at least 2 concurrent nonmetric traits at the same time, without any sex dimorphism (P = 0.658). CONCLUSION: Sex dimorphism exists considerably in primary molars' sizes, but it is not as prevalent in their nonmetric traits or abnormalities. Primary molars' crown sizes are useful for sex identification; we calculated optimum cut-off points for this purpose, for the first time.

Effects of simulation-based flipped classroom in developing head and neck examination skills in dental students.

OBJECTIVES: To evaluate the effectiveness of a simulation-based flipped classroom in developing dental students' head and neck examination skills. METHODS: Second-year dental students (n = 118) participated in a simulation-based flipped classroom experience. A pre-class recorded lecture and video were posted online one week before the simulation date. In class, students completed a pre-quiz assessing pre-class coursework understanding of head and neck examination content. Then, students attended a question-and-answer session before the patient simulation. A formative assessment of head and neck examination simulation on a patient in the clinic was completed. Lastly, students completed an in-class post-quiz assessing understanding of head and neck examination content after the simulation, classroom simulation discussion, and open-response survey. RESULTS: Student post-quiz scores were significantly higher than pre-quiz scores, with an average improvement of 4.8 ± 7.2 percentage points. There was no difference between male and female improvement in scores. Student survey responses indicated that students liked combining simulation and flipped classroom methodology, flexibility with their schedules, learning at their pace, and opportunities for a deeper level of learning. Students reported wanting more practice sessions for their technical skills and more accessibility to faculty. CONCLUSIONS: According to this study's results, students had significantly higher post-quiz scores than pre-quiz scores and reported positive perceptions of this combined teaching technique. A simulation-based flipped classroom might be an effective teaching approach for developing head and neck examination skills that can be applied at other dental facilities with potentially similar results.

Oral Gastric Heterotopia: First Reported Case in the Hard Palate.

Gastric heterotopia is characterized by the presence of mature gastric tissue outside the stomach, yet its occurrence in the palate has not been previously documented. We describe a case of gastric heterotopia in the hard palate of an elderly female patient, presenting as a swollen mass with associated secretion. Given the patient's age and clinical symptoms, a presumptive diagnosis of a malignant tumor originating from the minor salivary glands was made. An incisional biopsy of the mass revealed gastric heterotopia. Subsequently, the extended excision of the lesion was performed, leading to the full resolution of the patient's symptoms. After a two-year follow-up period, no evidence of recurrence was observed. The importance of this case, underscored by the unprecedented location of gastric heterotopia, emphasizes the critical need for thorough evaluation to avert misdiagnosis, as well as the complete surgical excision of the lesion to prevent recurrence.

Benign Intraoral Soft Tissue Lesions in Children.

Benign intraoral soft tissue pathology in pediatric patients includes developmental, traumatic, inflammatory, and infectious lesions. Common pathology includes gingival cysts, mucoceles, fibromas, and parulis. Less common lesions include peripheral ossifying fibromas, congenital epulis of the newborn, and congenital mandibular duct atresia. Most of these lesions present at painless masses but can have significant effects on children and their caregivers. Although these lesions are generally harmless, evaluation and treatment is necessary for appropriate management and health of the child.

Integration of arts into dental education: Beauty in the histological photomicrographs.

Background/purpose: Integration of arts and humanities into dental education is important for developing holistically oriented dental professionals. This study aimed to survey dental students' perception of integrating arts and sciences into dental education with an innovative pedagogical approach through a photomicrograph competition. Materials and methods: Students used digital imaging tools and creative approaches to capture photomicrographs that revealed hidden beauty in oral tissue sections. The photomicrograph works were posted online for scoring. The scoring activity, questionnaire survey, and complimentary comments of the participants were conducted online using a Google form. Results: The photomicrograph competition garnered a 24% participation rate from the 490 undergraduate dental students. Of the 116 participants, 65% agreed that the photomicrograph competition increased their interest in learning microscopic lessons, 87% very strongly or strongly supported to hold the photomicrograph competition every year, and 72% believed that the photomicrograph competition could be adopted to the dental students in all dental schools in Taiwan. The overall satisfaction rate of the photomicrograph competition was 91%. The free comments from all participants were generally positive towards this photomicrograph competition. Conclusion: The photomicrograph competition shows the transformative potential of integrating arts and humanities into dental education. Through the lens of photomicrography, the hidden wonders in oral tissue sections have been unveiled. This photomicrograph competition, a pioneering endeavor with no precedent in English literature, has proven to be a resounding success that unites the realms of scientific inquiry and artistic expression, and may be a transformative agent in nurturing holistic dental professionals.

Hamartomas, choristomas, and teratomas of the oral cavity: A 49-years cross-sectional study in an oral diagnostic service.

BACKGROUND: To investigate the incidence and demographic profile of hamartomatous, choristomatous, and teratoid lesions in a Brazilian population over a 49 years-period. METHODS: A retrospective cross-sectional study was performed, and data regarding demographic and clinical aspects were obtained from the medical records of a [removed for blind peer review] referral center (1970-2019). The collected data were submitted to descriptive analysis and Pearson's chi-square, Fisher's exact, and Kruskal-Wallis tests (p ≤ 0.05). RESULTS: In a total of 16,412 medical records analyzed, 300 (1.83 %) were hamartomatous, 2 (0.01 %) choristomatous, and 1 (0.01 %) teratoid lesions. Hamartomas were most diagnosed in females and adults. Statistical significance was observed between hamartoma and age group (p < 0.001). Odontoma was the most frequent hamartomatous lesion. In choristomatous and teratoid lesions, there was no occurrence in males. The jaws were the most affected anatomical site by hamartoma. Choristomas were observed on the mandible and tongue, while a teratoid lesion was seen on the floor of the mouth. CONCLUSIONS: Low occurrence of choristomatous and teratoid lesions over hamartomatous lesions and a heterogeneous occurrence profile regarding sex, age group, and anatomic site were observed. Hamartomas are relatively common and benign conditions that may cause damage and require special care during dental treatment. Thus, the dentist needs to be able to identify and treat them appropriately. Likewise, although choristomas and teratomas present no risk to patients and have a lower occurrence than hamartomas, they also require treatment.

The role of leukocyte and platelet-rich fibrin in the prevention of medication-related osteonecrosis of the jaw, in patients requiring dental extractions: an observational study.

PURPOSE: Medication-related osteonecrosis of the jaw (MRONJ) is a significant complication which can present following a dental extraction in patients receiving anti-resorptive and anti-angiogenic medications. The purpose of this study was to investigate the possible beneficial effect of L-PRF in the prevention of MRONJ in patients receiving these medications and requiring dental extractions. METHODS: Thirty-nine patients were included and divided into two groups, depending on whether L-PRF was used after the required dental extraction or not. Subsequently, the patients were categorised into low and high-risk for developing MRONJ, as recommended by the SDCEP guidance. RESULTS: None of the patients in the L-PRF group returned with established MRONJ. Five high-risk patients in the control group presented with established MRONJ in the follow-up appointment. A significant statistical difference (p = 0.04) was observed following a comparison of the high-risk patients of the two groups. CONCLUSION: These encouraging results suggest that L-PRF may be useful in the prevention of MRONJ following a dental extraction especially in patients of the higher risk category. A protocol for the management of this type of patients is also introduced.

The Patterns of Impacted Third Molars and Their Associated Pathologies: A Retrospective Observational Study of 704 Patients.

Background: The study aims to investigate parameters in patients attending Fujairah Dental Center, including assessing the prevalence of impacted teeth, determining the frequency of associated pathological conditions, and evaluating the patterns and angulations of impacted third molars. Methods: It is a retrospective descriptive study of the panoramic radiographs of patients who attended Fujairah Dental Center for dental care between January 2011 and December 2017. The minimum age for inclusion was 17 years. Clinical records were used to obtain the demographic details of patients, such as age, gender, nationality, medical history, and smoking history. Seven hundred and four panoramic radiographs and clinical records of patients were analyzed. The age range was between 17 and 112 years old, with a mean age of 34 years (S.D 13.5). Results: Of the 704 panoramic radiographs evaluated, 236 (33.6%) X-rays showed teeth impaction with a total of 562 impacted teeth in the upper and lower jaws. Five hundred and twenty-five (93.4%) were impacted third molars, and 37 (6.5%) teeth were other kinds of impacted teeth. Females showed a higher frequency of impacted teeth (62.6%) compared to males (37.4%). The highest prevalence of impacted teeth was found in the 17-25 year age group (61%), and the prevalence declined with advancing age. Impacted third molars were more likely to occur in the mandible (57.3%) than in the maxilla (42.7%). Most of the impacted third molars were in the mesioangular position, followed by the vertical position. The evaluation of the depth of impacted third molars demonstrated that level C impaction was the most frequently seen, followed by level B impaction. Impacted third-molar teeth often presented with two roots (60.7%), followed by a single root (31.3%). An evaluation of the relationship between lower third molars and the inferior dental canal (IDC) revealed that the most frequently observed relation was interrupted (61.5%), followed by a distant relation to the ID canal, and 13% were superimposed. The most common morphological pattern of roots of the impacted third molars was either straight-type or curved and dilacerated roots (5.7%). Additionally, the most noticed pathological conditions associated with impacted teeth were carious second molars adjacent to impacted third molars (42%), which was more likely to be seen in the 17-25-year age group, with females having a higher prevalence than males.

Microfragmented Fat and Biphasic Calcium Phosphates for Alveolar Cleft Repair: Protocol for a Prospective, Nonblinded, First-in-Human Clinical Study.

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.