Clinical Research Directory

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.

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.

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.

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.

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.

ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE

This cross-sectional study aims to evaluate the relationship between oral hygiene habits, periodontal status, and oral health-related quality of life in adult individuals. A total of approximately 160 participants attending the Department of Periodontology will be included. Periodontal status will be assessed using standard clinical parameters, including probing depth, clinical attachment loss, bleeding on probing, and plaque index. In addition, the Periodontal Inflamed Surface Area (PISA) will be calculated to quantify inflammatory burden. Oral health-related quality of life will be evaluated using the OSHIP-Perio questionnaire, a validated patient-reported outcome measure specific to periodontal conditions. The study will investigate the association between clinical periodontal findings, oral hygiene practices, and quality of life outcomes. The findings are expected to provide a comprehensive understanding of both clinical and patient-centered aspects of periodontal disease and contribute to improved individualized treatment approaches.

Improving Gum Health Among Older Adults Using AI Based mHealth for Personalized OHI

Background: Many older adults in Hong Kong lack thorough tooth cleaning and regular dental check-ups, which can lead to plaque-induced gum diseases and systemic health issues. A self-developed Mobile Health (mHealth) system, which utilizes smartphone photographs and artificial intelligence (AI), has been shown to accurately detect gum health. Personalized oral hygiene instruction (POHI) can then be provided based on the detected results. Objectives: 1. To improve gum health among non-institutionalized older adults using mHealth and POHI. 2. To evaluate the clinical effectiveness of mHealth and POHI in improving gum health. Hypothesis: The personalized oral hygiene instruction (OHI) in addition to AI based mHealth provided by volunteer social workers can improve clinical effectiveness and oral health related quality of life (OHRQoL). Design and subjects: 88 older adults will be recruited from daycare centers, who will receive bi-weekly POHI based on their gum condition, detected by mHealth which is provided by trained volunteers. Two calibrated assessors will assess the participants' gum health, oral hygiene, caries, dental plaque, and structured questionnaire at baseline, after 3 months, 6 months, 9 months and 1 year Study Instruments: Gingival Index, Plaque Index, International Caries Detection and Assessment System (ICDAS) code, dental plaque microbiology, and Geriatric Oral Health Assessment Index (GOHAI) + Structured Questionnaire. Interventions: Personalized oral hygiene instruction using AI-powered mHealth provided by trained volunteers bi-weekly Main Outcomes: Gingival condition, Oral hygiene status, Dental plaque microbiology, and oral health-related quality of life. Data analysis: t-tests and Wilcoxon rank-sum test will compare pre- and post-intervention data. Expected Result: The use of mHealth and POHI provided by trained volunteers bi-weekly can lead to improved gum health among older adults.

Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies

Periodontitits is a bacteria induced inflammatory disease that destroys the supporting tissues of the tooth and leads to tooth loss. Treatment consists mainly of the mechanical cleaning of the tooth surfaces in order to remove the bacterial deposits (plaque and calculus). This procedure can reduce the level of pathogenic bacteria but it can not eradicate them. In severe cases, for the complete resolution of the disease, the elimantion of certain species of bacteria is needed. In order to achieve that, the combination of different regimens of antibiotics adjunctive to the mechanical treatment has been proposed. However, dosage and duration of antimicrobial therapy should be optimal and not excessive as issues may arise related to increased antimicrobial resistance in the population and the individual due to habitual prescription of wide-spectrum antibiotic regimens, horizontal gene transfer and genetic mutation. In the present study, in an effort to optimize the dosage and duration of the antimicrobial regimen, we will determine the pharmacokinetics (PK) and pharmacodynamic (PD) properties of the MET-AMO combination and of AZI in Gingival Crevicular Fluid (GCF), saliva and serum in severe periodontitis patients during and after either a 3-day or a 7-day course of treatment.

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.

Evaluation of the Effects of Levodopa-Benserazide Drug Combination on Periodontal Status in Patients With Parkinson's Disease

The aim of this study is to evaluate the effects of Levodopa-Benserazide drug combination on periodontal status and salivary cytokine levels in patients with Parkinson's disease. The study includes four groups: Parkinson's patients with periodontitis, periodontally healthy Parkinson's patients, participants without Parkinson's with periodontitis, and periodontally healthy participants without Parkinson's. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Pocket Depth, and Clinical Attachment Loss) will be recorded. Unstimulated saliva samples will be collected to analyze the levels of TNF-alpha, RANTES, IL-10, IL-13, Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Malondialdehyde (MDA).

Interdental Hygiene Methods in Young Adults

Oral health is essential for overall well-being and systemic health. A key factor in preserving this health is maintaining the balance of the interdental microbiota, which involves regulating the quantity of pathogenic bacteria in interdental spaces (IS). These IS represent a unique ecological niche where the body has limited specific defense mechanisms, making them vulnerable to infections. In adults, the colonization of interdental spaces by pathogenic bacteria increases the risk of periodontal diseases, which are themselves associated with non-communicable diseases such as cardiovascular diseases, diabetes, and certain types of cancer. Preventing interdental microbiota dysbiosis from a young age is therefore a priority to maintain quality oral health and contribute to good systemic health throughout life. However, conventional brushing techniques cover only accessible tooth surfaces and cannot reach the interdental spaces. Currently, the use of interdental brushes (IDBs) is recognized as the most effective method for interdental hygiene. There are various types of IDBs, differing in several aspects that influence their effectiveness and usability. The main differences relate to their shape, size, and calibration using an interdental probe or not, allowing adaptation to different interdental space sizes. To date, only one study has demonstrated the effectiveness of daily calibrated interdental brush use in reducing dysbiosis and interdental inflammation among young adults. However, no research has yet been conducted to compare the effectiveness of the various types of IDBs available on the market (calibrated versus non-calibrated).

Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice

Periodontitis is a bacterial inflammatory disease and antibiotic use is being empirically used as part of its treatment. However, a clinical practice guideline on periodontal treatment adjuncts published in 2015 identified weak evidence on the use of systemic antibiotics and large heterogeneity across small scale studies, suggesting that larger pragmatic clinical trials would benefit clinical decision making. This will be a prospective, randomized, placebo-controlled trial, stratified by practice and practitioner. The study will investigate the effectiveness of adjunctive antibiotics as adjunct to scaling and root planing (SRP) compared to SRP with placebo for the treatment of generalized grades A-C periodontitis in patient participants from National Dental PBRN practices. Periodontal data will be collected at baseline, re-evaluation (6 weeks), and final (4-12 months) study visits. Changes in periodontal clinical and patient-reported outcomes will be assessed to determine the effectiveness of SRP plus adjunctive systemic Amoxicillin / Metronidazole antibiotics (AMXM) versus SRP with Placebo.

Klotho Gene, Red Complex Bacteria and Periodontal Viruses in Patients With and Without Periodontitis and Acute Coronary Syndrome

The Klotho gene was initially identified as an aging suppressor gene, but subsequent research revealed its multifaceted functions, encompassing antioxidant defense, anti-inflammatory effects, calcium and phosphorus balance, metabolic regulation, and anti-apoptotic activity. It encodes a single pass transmembrane protein and is expressed primarily in renal tubules. The Klotho protein exists in two forms: membrane-bound and secreted. Membrane Klotho acts as a co-receptor for FGF23, a bone-derived hormone, while secreted Klotho regulates various cell surface glycoproteins, including ion channels and growth factor receptors. Klotho has recently emerged as a potential biomarker for coronary heart disease, with evidence suggesting its involvement in the disease's pathophysiology. The red complex, comprising Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia harbors key pathogens in adult periodontal disease. These bacteria possess various virulence factors, including fimbriae, lipopolysaccharides, and proteases in P. gingivalis, which disrupt inflammatory and immune responses and degrade connective tissue proteins. T. forsythia produces a trypsin-like protease, sialidase, hemagglutinin, and BspA, contributing to alveolar bone loss. Meanwhile, T. denticola disrupts the host cell extracellular matrix, penetrates tissue, and dysregulates immunoregulatory factors, further exacerbating periodontal disease. Similarly, Herpes Simplex Virus 1 (HSV-1), human Cytomegalovirus (HCMV) and Epstein Barr Virus (EBV) have been implicated in the pathogenesis of periodontal disease. The expressions of viruses along the red complex bacteria would provide further evidence of periodontal risk in progression of acute coronary artery disease.

Oral Health In Cirrhosis of the Liver (ORACLE)

The goal of this observational study is to learn about dental evaluation and periodontal cleaning along with scheduled follow -up on the dental health and overall health of patients with cirrhosis and also to determine what barrier(s) if any exist to improve oral health in this population.

Education-Based Oral Health Promotion Intervention During Pregnancy: Implementation Protocol in Bangladesh

In Bangladesh, over 95% of pregnant women suffer from gum disease (gingivitis or periodontitis), yet oral health is rarely included in standard pregnancy check-ups. This study tests a new "Integrated Oral Health Promotion Package" to see if teaching oral hygiene during routine prenatal visits can improve the health of mothers. Pregnant women (ages 18-45) will be divided into two groups. The intervention group will receive two face-to-face education sessions with a dental assistant, learn a specific tooth-brushing technique, and receive weekly SMS text reminders to brush their teeth. The control group will receive the standard pregnancy care currently offered in Bangladesh. Researchers will track the participants for 12 weeks to see if the education and reminders lead to better brushing habits (twice-daily) and cleaner teeth and gums compared to the standard care group.

Oral Health, Dento-facial Condition and OHRQoL in Subjects With Mowat-Wilson Syndrome: an Epidemiologic Study.

Mowat-Wilson Syndrome (MWS) is a rare syndrome characterized by the presence of facial gestalt and delayed psychomotor development, variably associated with intellectual disability, epilepsy, Hirschsprung's disease (HSCR) and multiple congenital malformations. Although there is evidence of the presence of dental and craniofacial anomalies in MWS, little epidemiological data is available to date. The goal of this observational study is to assess oral health and dento-facial phenotype of people affected by Mowat-Wilson Syndrome (MWS). In addition, the Oral Health Related Quality of Life (OHRQoL) will be investigated.

Microbiological Effect of 0.12% Chlorhexidine Digluconate and 0.05% Cetylpyridinium Chloride vs Probiotics (Lactobacillus Reuteri Prodentis) on Porphyromonas Gingivalis.

This randomized non-inferiority clinical trial aims to evaluate the microbiological effect of 0.12% chlorhexidine and 0.05% cetylpyridinium vs. probiotics (Lactobacillus reuteri Prodentis) on Porphyromonas gingivalis in patients with periodontal disease and diabetes mellitus in Colima, where molecular biology tests such as qPCR will be performed at the end, before and after treatment in each of the groups.

Development, Validation, and Assessment of the Diagnostic Accuracy of a Questionnaire for Periodontitis Screening

The present study aims at validating the Italian version of one of the most widely used epidemiological questionnaires for periodontitis screening: the CDC/AAP questionnaire \[hereafter referred to as the CDC/AAP\_ITA questionnaire\]. The study also aims to develop a modified version of the CDC/AAP questionnaire, enriched with additional questions, and to evaluate its diagnostic accuracy \[hereafter referred to as the QSIdP questionnaire\]. The study will be conducted at the Unità Complessa di Odontoiatria, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara (Director: Prof. Leonardo Trombelli), in collaboration with nine (9) other Italian clinical centers.