Clinical Research Directory

Asprosin and Total Antioxidant/Oxidant Status in Diabetes and Periodontal Disease

The goal of this observational study is to learn about how different periodontal health status affects the levels of asprosin (a hormone) and total oxidant/antioxidant status in the gingival crevicular fluid and blood serum of individuals with Type 2 diabetes. The main questions it aims to answer are: Do individuals with Type 2 diabetes and periodontal disease have different levels of asprosin and oxidative stress markers compared to diabetic individuals with healthy gingiva ? How do local changes in the gingiva relate to systemic (body-wide) biomarkers in diabetic patients? Participants with Type 2 diabetes will undergo a routine clinical periodontal examination to evaluate their gingival health. During their regular clinic visit, samples of fluid from around their gingiva (gingival crevicular fluid) and routine blood samples (serum) will be collected to measure and compare these biochemical markers

Deep Learning-Based Measurement of Keratinized Gingiva Width Using Smartphone-Acquired Clinical Images

This study aims to develop and validate an artificial intelligence-based system for automated measurement of keratinized gingiva width using smartphone-acquired intraoral clinical photographs. Standardized intraoral images will be collected and analyzed using a deep learning model, and the results will be compared with clinical measurements performed by calibrated expert examiners, which serve as the reference standard. The performance of the proposed system will be evaluated using accuracy metrics including Dice coefficient, Intersection over Union (IoU), precision, recall, and F1-score. This study seeks to support the integration of AI tools into periodontal diagnosis and clinical decision-making to improve measurement consistency and reduce inter-examiner variability.

Association Between Periodontitis and the Level of Anti-citrullinated Protein Antibodies in Rheumatoid Arthritis

the relationship between rheumatoid arthritis and periodontal disease is crucial and has been explained via a complex interplay of genetic, environmental, and hormonal factors that influence the host immune tolerance leading to both disease characteristics. The aim of this study is to clinically investigate the correlation between the levels of anti-citrullinated protein antibodies (ACPAs) in gingival crevicular fluid and the severity of periodontal disease and rheumatoid arthritis in rheumatoid arthritis (RA) patients

3D Printed Customized Bone Graft for Alveolar Regeneration: Longitudinal Cohort Evaluation

This study will evaluate the behavior of the implant-supported restorations (prosthesis) placed into the areas grafted with the 3D printed customized bone (personalized graft produced to fit a specific bone defect), as well as the volume contraction of the printed bone.

Autologous Platelet Concentrate (APC) in Intrabony Defects

The aim of this 12-month clinical study is to treat patients affected by gum disease (periodontitis) by a minor gum surgery that aims to reduce the depth of the gum pockets. In particular, the study will compare two types of gum surgery, one based on the use of a product derived from the patients' own blood (PRGF, platelet autologous concentrate), and the other based on the use of an animal-derived bone graft and membrane that have been in the market for the past 30 years. Both procedures aim to regenerate bone and gum tissue that is damaged by the disease. 74, ≥ 25-year-old, otherwise healthy, patients affected by gum disease will be recruited at the Barts and The London Dental Hospital. Participants will be randomly (by chance) assigned to receive one of the two treatments. Throughout the study, we will assess gum's health by taking some measurements around teeth and gums. In addition, we will use non-invasive technologies to assess changes in temperature, blood flow and face's swelling at different time-points. Patients will be given specific questionnaires to evaluate their preferences and the impact that each surgical treatment had in their everyday life. One intra-oral x-ray will be performed before the surgery and after 12 months to assess if new bone has formed around the teeth involved in the surgery, as per standard procedure.

Evaluation of the Impact of Periodontitis and Its Treatment on Swallowing Functions and Oral Quality of Life

The objective of this single-center prospective study is to evaluate the impact of periodontal treatment on masticatory performance in patients with periodontitis. Participants will be asked to complete several questionnaires related to their oral health and quality of life. Functional masticatory tests and salivary flow measurements will also be performed.

Hyaluronic Acid and Polynucleotides for Supra-bony Defects

The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.

Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement

The objectives of this study are to analyze the oral microbiome modulations occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis; to evaluate if microbiome changes in relation to the used of different implant material/surface; and to assess the variance of the changes to determine the sample size for future longitudinal prospective studies.

LONGITUDINAL FOLLOW-UP STUDY TO DETERMINE THE PREDICTIVE ABILITY OF A PANEL OF BIOMARKERS IN SALIVA IN HEALTHY AND PERIODONTALLY AFFECTED PATIENTS

Objective: The main aim of this longitudinal clinical study is to evaluate the predictive ability of a panel of salivary biomarkers in determining periodontal health status in 2 years follow up in a group of healthy and periodontally affected individuals. Material and methods: In this longitudinal, observational follow-up study, patients previously enrolled in a cross-sectional study at the Periodontal Postgraduate Clinic, University Complutense of Madrid, will be re-evaluated over a 2-year period. Participants (≥18 years) will be categorized into diagnostic groups based on the 2018 classification of periodontal diseases, including periodontally healthy, gingivitis, treated periodontitis (stable/unstable), and various stages of periodontitis. The study will include follow-up visits at 1 and 2 years. At each visit, participants will undergo a comprehensive medical examination to assess age, gender, weight, height, waist circumference, blood pressure, temperature, smoking and alcohol history, systemic health, and HbA1c levels. A periodontal examination will be performed at six sites per tooth, and clinical parameters including plaque, bleeding on probing, probing depth, recession, and tooth loss will be recorded. Saliva and subgingival plaque samples will be collected for biomarker and microbiological analysis. Salivary biomarkers will be measured using multiplex immunoassays, and bacterial quantification will be performed by multiplex qPCR. Data analyses: Descriptive statistics will be used to report the clinical variables and patients will be grouped according to the pre-established diagnostic categories (periodontally healthy, gingivitis, treated periodontitis patient. In order to determine the possible statistical relationship with the medical, biochemical and microbiological variables assessed, a crude bivariate analysis will first be performed by applying a mean comparison test for quantitative variables (ANOVA) and a proportion comparison test for categorical variables (Chi-square). Subsequently, those variables identified as relevant in the crude analyses will be included as confounding and/or interaction factors in a binary logistic regression model, considering the presence of periodontitis as a response variable, in order to obtain crude and adjusted OR values, together with their corresponding 95% CIs. Based on the results obtained in the biomarker analysis, a relevant statistical analysis will be performed, taking into account all the variables collected in the study. For periodontitis cases, treatment response over time will be analyzed, with subgroup comparisons between responders and non-responders.

Evaluation of the Effect of Hyperuricemia on Alveolar Bone Loss

Periodontitis is a multifactorial disease characterized by chronic inflammation of the gum tissue and alveolar bone destruction, and is known to be associated with various systemic diseases. Hyperuricemia, on the other hand, is a metabolic condition characterized by increased serum uric acid levels and can affect inflammation, oxidative stress, and bone metabolism. In recent years, the relationship between hyperuricemia and periodontal diseases has been increasingly investigated, but the biological mechanisms of this relationship have not yet been fully elucidated. Therefore, this study aimed to determine whether there is a relationship between hyperuricemia and periodontitis and to reveal the possible pathophysiological mechanisms of this relationship, which are shaped by inflammation, oxidative stress, and bone metabolism. A total of 80 individuals aged 18-65 years will be included in this clinical observational study. The periodontal status of the participants will be assessed using clinical periodontal parameters such as probing pocket depth, clinical attachment loss, plaque index, gingival index, and bleeding on probing. Participants will be divided into four groups according to their periodontal status and the presence of hyperuricemia: individuals with periodontitis and hyperuricemia, individuals with periodontally healthy and hyperuricemia, individuals with periodontitis but without hyperuricemia, and individuals with periodontally healthy and without hyperuricemia. Gingival crevicular fluid and serum samples will be taken from the participants. In these samples, receptor-mediated nuclear factor kappa B ligand, osteoprotegerin, total antioxidant status, total oxidant status, oxidative stress index, interleukin-1 beta, interleukin-10, interleukin-18, and nucleotide-binding oligomerization domain-like receptor protein 3 levels will be analyzed. This study is considered unique because it examines the relationship between hyperuricemia and periodontitis by evaluating inflammation, oxidative stress, and bone metabolism parameters together.

Assessment of Salivary Biomarker Levels in Individuals With Various Periodontal Diseases

The aim of this study is to compare the salivary levels of HIF-2 alpha, MMP-9, and TRAP-5b among healthy individuals, patients with gingivitis, and patients with periodontitis; to examine the relationship between these levels and clinical parameters; and to determine their effectiveness in distinguishing periodontal disease from a healthy condition. It will be evaluated whether these biochemical mediators can be used as diagnostic biomarkers in the diagnosis of periodontal disease. Periodontal health is defined as the absence of signs of inflammation. Gingivitis is an inflammation of the gums and, if left untreated, can progress to periodontitis, a more severe condition characterized by the destruction of the supporting structures of the teeth. In this destruction, the host immune response to bacterial products and various inflammatory mediators (cytokines, MMPs) play a role. MMP-9 plays a significant role in the progression of inflammation and tissue damage. HIF-2 alpha is a factor that regulates bone formation and resorption and is activated in hypoxic or inflammatory environments. TRAP-5b is a specific marker of osteoclast activity and bone resorption. In the literature, there is no study that evaluates these three biomarkers together in saliva samples in the context of periodontal disease. This study aims to investigate the changes in these salivary biomarkers in the presence of periodontal disease, their diagnostic potential, and their relationship with clinical parameters. The findings may also provide insights for future treatments targeting these cytokine pathways.

Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study.

The goal of this clinical trial is to learn whether the edge design of a finishing orthodontic clear aligner at the gumline affects the bacteria living in the groove between the tooth and the gum (the gingival sulcus) in patients undergoing the finishing phase of orthodontic treatment. The main question it aims to answer is: \- Does a supragingival aligner edge design - which covers approximately 2 mm of gum tissue - lead to higher levels of disease-associated bacteria in the gingival sulcus compared to a juxtagingival edge design that follows the gumline exactly, after 4 and 8 weeks of aligner wear? Researchers will compare the supragingival trimming-line design to the juxtagingival festooned design to see if covering gum tissue with the aligner edge creates conditions that favor the growth of anaerobic bacteria associated with gum disease. Participants will: * Wear finishing clear aligners with both designs simultaneously - one design on the upper jaw and one on the lower jaw - for 8 weeks * Provide fluid samples from the gum groove at 3 visits: at the start of treatment (baseline), at 4 weeks, and at 8 weeks. Two aligner edge designs are compared: a supragingival design, which has a straight horizontal edge positioned approximately 2 mm over the gumline, covering approximately 2 mm of gum tissue with direct contact but without entering the gum groove itself, and a juxtagingival design, which follows the natural scalloped shape of the gumline exactly, terminating at the free gingival margin without covering gum tissue and without entering the groove. The biological rationale for comparing these two designs is the following: the supragingival design, by covering 2 mm of gum tissue, creates a partially enclosed space at the entrance of the gum groove, potentially reducing the clearance of saliva and limiting oxygen access to that area. These conditions may favor the growth of anaerobic bacteria associated with gum disease. The juxtagingival design, by following the gum contour exactly at its edge, leaves the gum groove entrance more accessible to saliva and oxygen, potentially maintaining a less favorable environment for those bacteria. Each participant receives both designs at the same time - one on the upper jaw and one on the lower jaw - and serves as their own comparison group. This within-person (split-mouth) approach eliminates differences between individuals in general health, oral hygiene habits, and saliva composition, making the comparison between the two designs more precise. Samples are analyzed using the PeriodontScreen Real-TM real-time PCR kit (Sacace Biotechnologies Srl, Como, Italy; CE-marked in vitro diagnostic device), which detects and quantifies seven bacteria known to cause gum disease: Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Porphyromonas endodontalis, Fusobacterium nucleatum, and Prevotella intermedia. The main measurement is the number of these seven bacteria that exceed the clinically significant concentration threshold defined by the kit at each jaw arch and time point. A score of 0 means none of the seven bacteria exceed the threshold; a score of 7 means all seven do. The study hypothesis is that the supragingival trimming-line design - by covering gingival tissue and partially enclosing the sulcus entrance - creates microenvironmental conditions that favor anaerobic periodontal pathogen colonization, resulting in higher pathogen burden scores compared to the juxtagingival design after 4 and 8 weeks of finishing aligner wear. The study is conducted during the finishing phase of orthodontic treatment, when planned tooth movements are minimal (no more than 0.5 mm per tooth), so that any differences in bacterial levels can be attributed to aligner edge design rather than to tooth movement forces.

Marginal Biofilm Distribution and Periodontal Response to Supragingival and Juxtagingival Aligner Designs

* This prospective, longitudinal, within-person (split-mouth) clinical study evaluates the influence of two clear aligner trimming-line designs on marginal soft-tissue biofilm distribution and periodontal tissue response over a six-month period. * Two trimming-line designs are compared. The supragingival design has a straight, horizontal edge that extends approximately 2 mm onto the marginal gingiva, resting in direct contact with the gingival surface but not entering the gingival sulcus. The juxtagingival design follows the scalloped contour of the gingival margin and terminates at the free gingival margin, without covering the gingiva and without entering the sulcus. * Each participant receives both designs simultaneously, one per dental arch, and therefore serves as their own control. The assignment of each design to an arch is determined by the treating clinician according to the orthodontic treatment indications and is not randomized. * The primary outcome is the percentage of sites with bleeding on probing per arch at six months. Secondary outcomes are bleeding on probing at three months, mean probing depth, maximum probing depth, and the Turesky-Quigley-Hein plaque index, with three exploratory photographic soft-tissue variables describing marginal gingival plaque presence, vestibular interdental papilla plaque presence, and the marginal demarcation pattern. Clinical and photographic assessments are performed at baseline (before aligner delivery), at three months, and at six months. * All aligners are fabricated from a tri-layer clear aligner material (CA Pro, SCHEU-DENTAL GmbH, Iserlohn, Germany) by a single orthodontic laboratory.

The Effect of Vitamin D Supplementation on the Anti-inflammatory Response in Periodontal Diseases

A review of the literature revealed that while there are studies investigating the relationship between vitamin D and periodontal disease, there are no studies investigating the anti-inflammatory effect of vitamin D on periodontal disease. Investigators hypothesized that the increased incidence of periodontal disease in individuals with vitamin D deficiency might be due not only to pro-inflammatory effects but also to impaired bone metabolism and a decrease in the anti- inflammatory mechanism. Investigators aimed to determine this by comparing serum and DOS levels of 1,25-dihydroxyvitamin D (1,25(OH)2D), 25-hydroxyvitamin D (25(OH)D3), Receptor activator nuclear kappa B ligand (RANKL), osteoprotegerin (OPG), Tumor Necrosis Factor Related Apoptosis induced Ligand (TRAIL), Developmental endothelial locus (Del)-1, Lipoxin, Resolvin, interleukin (IL)-10, and transforming growth factor-β (TGF-β). The study will include 120 individuals who are systemically healthy based on clinical and radiographic examinations and diagnosed with Stage I-II periodontitis, Stage III-IV periodontitis, chronic gingivitis, and periodontally healthy. Periodontal clinical parameters (Probing pocket depth (PPD), Clinical attachment level (CAL), Bleeding on probing (BOP), Plaque index (PI), Gingival index (GI)) will be recorded three times: before treatment, and 6 and 12 weeks after treatment. Gingival crevicular fluid (GCF) and serum samples will be collected from participants at baseline and 12 weeks later for biochemical analysis.

Tedlar Bag Stability of Volatile Sulfur Compounds for Remote Halitosis Diagnosis

Halitosis, or bad breath, affects about 30% of people worldwide and is most often caused by oral diseases such as periodontitis. To diagnose it, dentists usually perform a clinical examination and measure specific gases in the breath called volatile sulfur compounds (VSCs), which are responsible for bad odor. However, the equipment needed for this analysis is not widely available, forcing many patients to travel long distances. This study aims to determine whether breath samples can be collected and analyzed later, making remote diagnosis possible. Specifically, it evaluates whether the levels of these gases remain stable for up to 7 days after collection, with a variation of less than 20% considered acceptable. To do this, 100 adult patients with periodontal conditions will be included in a single-center study. During a single visit, patients will provide breath samples by exhaling into a special Tedlar bag and a syringe, which will then be analyzed immediately and again after 7 days using a device called OralChroma. Afull periodontal examination will also be performed, and patient information such as age and risk factors will be collected. The study will also examine how gas levels change over time and whether they are linked to gum disease. If the results confirm that the samples remain stable, this approach could allow patients to collect their breath at home and receive a diagnosis remotely, reducing the need for travel and improving access to care.

The Role of Diet in Periodontal Inflammation: A Controlled Clinical Study

Diet can influence the body's healing and repair mechanisms. A dietary imbalance obviously cannot trigger periodontal disease in the absence of a primum movens, which is bacterial plaque. However, it can condition its severity and extent by altering the permeability of the oral mucosa, the effectiveness of the immune response and the reparative potential of the gingival tissues. Nutraceuticals is the science that studies the effects of the so-called food-drug, i.e. those foods that contain substances capable of performing a pharmacological function, modifying the functions of the organism. In particular, some molecules that are assimilated through various foods are able to penetrate the cell nucleus and influence, through an epigenetic mechanism, the expression or otherwise of some genes. The aim of the present longitudinal quasi-experimental study was to evaluate the gingival inflammatory response to experimentally induced plaque accumulation in periodontally healthy vegans and omnivores and to explore whether systemic biomarkers mediated the observed clinical effects.

Clinical Effectiveness of Biologic Agents as an Adjunct to Non-surgical Periodontal Therapy of Intrabony Defects

The aim of the present study is to clinically and radiographically compare the efficacy of recombinant human platelet-derived growth factor (rhPDGF), Leukocyte-Platelet Rich Fibrin (L-PRF) and Enamel Matrix Derivatives (EMD) in intrabony defects following minimally invasive non surgical peridoontal therapy (MINST). This study will be designed as a randomized clinical trial of 12-month duration. A total of 88 patients (each with a single infrabony defect) will be recruited and randomly equally distributed into 4 groups: an experimental group treated with MINST and rhPDGF, a second group treated with MINST + L-PRF, a third group treated with MINST and EMD and and a control group treated with MINST alone. Each defect will be treated with an ultrasonic scaler with dedicated thin tips for supra- and subgingival debridement associated with hand instrumentation under local anesthesia. Caution will be taken to preserve the stability of soft tissues. Following MINST experimental and control sites will be randomly chosen. The test sites will be treated by inserting a collagen plug soaked for at least 15 minutes in a 1.5cc solution containing hPDGF-BB. In the second group the infrabony defects will be treated with MINST and L-PRF. In the third group the infrabony defects will be treated with MINST and EMD. The control group will be treated with MINST alone. Pre- and post-treatment clinical measurements were performed by an examiner blinded to the treatment modalities using a graded periodontal probe (HuFriedy UNC 15). Before the treatment and at 6 and 12 months post-treatment, all patients were examined by measuring the clinical attachment level, probing depth, gingival recession, full-mouth plaque score and bleeding on probing. Standardized radiographs of selected study sites will be taken at baseline and at the 6 and 12 months follow-up visits using the long-cone technique with a customized holder and a thermoplastic occlusal reference to allow reproducible positioning. All radiographs will be analysed by a dedicated dental software (Carestream Dental LLC Atlanta, GA, USA) to make linear measurements. The defect bone level (DBL), the defect angle (DA), the intra- and suprabony components of the defect and the radiographic defect area (RDA) will be evaluated.

Profiling Gingival Crevicular Fluid β-Catenin Level With 8-OHdG and Total Antioxidants Capacity During Healing of Periodontal Pockets: A 3-month Clinical Trial

Background: To profile gingival crevicular fluid (GCF) β-Catenin, 8-OHdG, and total antioxidants capacity (TAC) in periodontitis patients during healing of periodontal pockets following non-surgical periodontal therapy (NSPT).Methods: Periodontitis patients (n = 21) will included in this clinical trial. Clinical periodontal parameters will recorded and GCF samples will collected from randomly selected 4-6 mm periodontal pockets at baseline (T0) as well as 4 weeks (T1) and 12 weeks (T2) after NSPT. GCF levels of β-catenin, 8-OHdG, and TAC will be assayed by enzyme linked immunosorbent assay (ELISA).

An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis

The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-405 (manufactured by Erchonia Corporation (the Company) in providing a noninvasive adjunctive treatment in combination with periodontal scaling and root planing for improving the treatment of periodontal disease.

Candida Albicans in Syrian Patients With Periodontitis

Periodontitis is a significant oral health issue characterized by inflammation and destruction of the supporting structures of the teeth. Recent research has indicated that Candida albicans, a common fungal pathogen, may play a role in the exacerbation of periodontal diseases. This study aims to investigate the prevalence and impact of Candida albicans in Syrian patients diagnosed with periodontitis, contributing to a better understanding of its role in oral health within this population.

Evaluation of the Effectiveness of Odontogenic Grafts Obtained From Human Teeth on Bone Formation

Tooth extraction triggers a cascade of biological events mediated by the local inflammatory response following surgical intervention and by the loss of masticatory stimulation to the periodontium. These factors disrupt the homeostasis and structural integrity of the periodontal tissues. Following tooth loss, bone remodeling is initiated and continues for several months, with the majority of dimensional and morphological changes occurring within the first three months. This early alveolar bone resorption may compromise future implant placement and prosthetic rehabilitation. Previous studies by Schmidt-Schultz and Schultz have demonstrated that biologically intact growth factors can be preserved within the collagenous extracellular matrix of ancient human bone and teeth. These findings suggest that stored dentin may retain biologically active growth factors and provide regenerative benefits comparable to those of freshly prepared dentin, while eliminating the need for simultaneous multiple surgical interventions. Moreover, the volume of particulate dentin exceeds twice the original root volume, allowing for the acquisition of sufficient graft material for clinical application. Based on these biological and volumetric advantages, the use of autogenous stored mineralized dentin grafts (ASMDG) has emerged as a promising approach for alveolar socket preservation. ASMDG may contribute to limiting post-extraction alveolar ridge resorption and maintaining ridge dimensions during the critical early healing period.

Gingival Crevicular Fluid Levels of Prolactin Hormone in Obese Patients With Stage ii and Iii Periodontitis Before and After Non-surgical Periodontal Therapy

Obesity and periodontitis are among the most common chronic disorders affecting the world population, while Prolactin (PRL) is a neuroendocrine hormone that within the physiological range stimulates bone formation while mild to marked increase in its level induces bone resorption and inhibits bone formation. Aim of the study: study aims to investigate prolactin (PRL) levels in gingival crevicular fluid (GCF) in obese (O) patients with and without stage II and III periodontitis (P). Further, to evaluate the effect of non-surgical periodontal therapy on these levels compared to controls.

Development of A Self-Assessment Tool for Personalized Preventive Periodontal Care Among the Saudi Population Using Semi-Supervised Learning

This observational study will collect labeled data to assess the accuracy of an online periodontal self-assessment tool in adults. Participants will complete the questionnaire and then undergo a clinical periodontal examination during the same visit. The study will compare questionnaire-based results with clinical examination results to evaluate diagnostic accuracy and agreement.

Evaluation of the Effect of Smoking on Pyroptosis in Periodontal Pathogenesis

This study investigates the impact of smoking on pyroptosis and inflammatory signaling pathways in systemically healthy individuals with various periodontal conditions. The research compares smokers and non-smokers across three clinical categories, resulting in six study groups: Healthy Control, Gingivitis, and Periodontitis. The study specifically evaluates the levels of IL-1beta, IL-18, and NLRP3 through ELISA, and the gene expression of TLR1, TLR4, and TLR6 through RT-PCR, to understand how cigarette smoke modulates innate immune responses in the absence of other systemic diseases.