Clinical Research Directory

Oral Health and Systemic Diseases: Survey of General Practitioners

This cross-sectional observational study aims to assess the level of knowledge, clinical practices, and professional attitudes of General Practitioners (GPs) regarding oral health and its relationship with major systemic diseases, with particular emphasis on periodontal disease. Data will be collected through an anonymous, self-administered digital questionnaire distributed nationwide to General Practitioners practicing in Italy. The questionnaire will investigate participants' knowledge of oral diseases, awareness of oral-systemic associations, early identification of oral manifestations, educational background, and interdisciplinary collaboration with dental professionals.

Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)

Background: \- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth. Objectives: \- To study how immune system problems may lead to problems in the mouth, including gum disease. Eligibility: * Children and adults at least 7 years of age who have genetic problems with their immune system. * Healthy adults that have periodontal disease * Health adults that do not have periodontal disease Design: * This study will involve a screening visit and a study visit. * Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos. * The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.

Evaluation of Liquorice Nanogel Versus Diode Laser as an Adjunctive Treatment for Patients With Periodontitis Stage Ⅲ.

Evaluation of the effect of liquorice nanogel versus diode laser on periodontitis stage Ⅲ clinically and microbiologically by molecular analysis of porphyromonas gingivalis using real time PCR.

A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients

The goal of this clinical trial is to learn if a novel peptide-rich hydrogel works to achieve periodontal regeneration in adults. It will also learn about the safety of the hydrogel. The main questions it aims to answer are: * Does the novel peptide hydrogel achieve periodontal regeneration to a similar degree as another currently used therapy (hyaluronic acid)? * What medical problems, if any, do participants have when receiving the novel hydrogel treatment? Researchers will compare the novel peptide hydrogel to another commonly used hydrogel (hyaluronic acid) to see if the peptide hydrogel works to treat periodontal bone defects. Participants will: * Receive the novel hydorgel or hyaluronic acid when they undergo periodontal regenerative surgery * Visit the clinic at regular intervals for 1 year after the surgery for follow ups

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.

Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.

The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.

Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)

This study aims to evaluate the burden and phenotypic spectrum of periodontal disease in patients with rare kidney disorders (such as Alport syndrome, Fabry disease, and tuberous sclerosis complex) and systemic lupus erythematosus (SLE), compared with chronic kidney disease (CKD) controls and population controls. This is a cross-sectional, case-control observational study. Participants will undergo a single structured evaluation including a full-mouth periodontal examination, a clinical questionnaire, and collection of relevant clinical and nephrological data. The primary objective is to compare the prevalence of periodontitis across study groups. Secondary objectives include characterization of periodontal disease severity, prevalence of gingivitis and xerostomia, and identification of disease-specific oral phenotypes. Exploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.

Efficacy of Laser Therapy for Periodontitis

The aim of this study is to evaluate the efficacy of diode laser in addition to periodontal treatment in periodontitis patients and to investigate their effects on gingival crevicular fluid (GCF) cytokine levels before and after treatment, among some Yemeni individuals in Sana'a city.

Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial

Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight. Infants who have at least one of these outcomes, known as small vulnerable newborns (SVN)), are at increased risk of early death and poor infant growth and development. Rigorous, high-quality randomized trials are needed to evaluate whether improving the periodontal health of pregnant women can reduce the risk of adverse pregnancy outcomes in areas like South Asia, where these outcomes are common and neonatal mortality remains high. This study is a community-based, randomized controlled trial (n=2,280) to evaluate a package of oral health interventions delivered to pregnant women in the first trimester until delivery on the incidence of SVNs in rural Sarlahi District, Nepal. The intervention package will include a daily antiseptic oral rinse and intensive oral hygiene education and instruction. Both intervention and control groups will be provided a manual toothbrush and toothpaste. The investigators will determine intervention effects on incidence of SVNs and individual outcomes of preterm birth, small-for-gestational age, and low birth weight. In a biospecimen sub-study (n=200), the investigators will collect venous blood, gingival crevicular fluid, and plaque in early and late pregnancy to explore relationships between subgingival inflammation, systemic inflammation, and SVN types and other adverse pregnancy outcomes. If efficacious, a low-cost package of oral health interventions - including an antiseptic oral rinse, intensive oral hygiene education and instruction, and provision of a manual toothbrush and toothpaste - could improve maternal and newborn outcomes at this critical time of growth and development.

Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Transcrestal Sinus Floor Elevation With Graftless Immediate Implant Placement in Subsinus Bone Height of 4-6 mm: A Pilot Study.

This present study will evaluate Schneiderian membrane perforation rates using osseodensification in TSFE with simultaneous graftless implant placement, under sinuscopic control monitored by an ENT specialist. An endoscopic evaluation will be continuously conducted throughout the surgical procedure. TSFE will be performed using Densah burs without the addition of bone graft material, followed by implant placement. The rationale behind this approach is to monitor the response of the Schneiderian membrane and assess the effects of Densah burs on membrane distention and the occurrence of SMP.

Diagnostic Accuracy of Oral Images, OPGs, Biomarkers and Questionnaires vs. Clinical Assessment for Periodontal Disease (PostNCT07164573)

This multi-center, cross-sectional diagnostic trial evaluates the accuracy of multiple non-invasive screening tools-including self-reported questionnaires, intra-oral photographs, orthopantomographs (OPGs), intraoral scans (IOS), and salivary/microbial biomarkers-for detecting periodontal health and diseases (gingivitis and periodontitis Stages I-IV), using full-mouth clinical periodontal examination as the reference standard. A total of 2,000 participants will be recruited across five international centers. Diagnostic performance (sensitivity, specificity, AUROC) of individual and combined methods will be assessed using logistic regression and machine learning algorithms to establish an optimized multi-modal screening algorithm.

ABX Versus CHX in NSPT

The study aims to compare the efficacy of a novel mouthwash based on microRepair ABX and an antibacterial complex with that of 0.12% chlorhexidine, both used as adjuncts to scaling and root planing.

Efficacy of Chlorhexidine and Morus Nigra Mouthwashes After Periodontal Treatment

This study aims to evaluate and compare the clinical, biochemical, and microbiological effects of chlorhexidine and Morus nigra (blackberry) mouthwashes used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with periodontal diseases. The participants will be divided into three groups: a control group receiving only SRP, a group receiving SRP combined with chlorhexidine mouthwash, and a group receiving SRP combined with Morus nigra mouthwash. Clinical periodontal parameters, gingival crevicular fluid levels of inflammatory markers (including TNF-a, IL-1b, and IL-10), and subgingival plaque microbiological profiles (such as red complex bacteria and Fusobacterium) will be evaluated at baseline, 1 month, and 3 months after the treatment.

Serum Inflammatory Protein Concentration During Dental Treatment

The goal of this observational study is to study the molecular markers of stress in blood samples from people who are having periodontal surgery. The main question it aims to answer are: * How do the levels of inflammatory molecules in the blood change during a periodontal surgery? * How are the levels of inflammatory molecules in a person having surgery different from the levels in a person having a nonsurgical procedure? * Participants will be people who are having a periodontal surgery or a nonsurgical periodontal treatment as part of their dental care. Participants will be asked to let the investigator take blood samples from them before, during, and after the procedure is being done. The blood will later be analyzed for substances in the blood that are associated with inflammation.

Impact of Atypical Swallowing on Periodontal Health in Adults

This study aims to evaluate the prevalence of atypical (dysfunctional) swallowing in an adult population affected by periodontitis. The research investigates the correlation between dysfunctional swallowing patterns - characterized by abnormal tongue thrust-and clinical oral manifestations such as dental mobility and the worsening of periodontal conditions. By analyzing data collected through patient questionnaires and clinical evaluations, the study seeks to highlight how incorrect lingual posture and pressure can negatively influence the integrity of the tooth-supporting tissues in adults.

CHEER Oral Health in Pregnancy Study

Many pregnant people don't get the dental care they need, even though it's safe and important. The CHEER Study offers free dental check-ups, cleanings, and supplies to help participants take care of their teeth and gums during pregnancy. The purpose of this research study is to compare two types of noninvasive oral health interventions to evaluate their effectiveness. We want to learn if one method is more effective in supporting oral health and improving pregnancy outcomes. There are two aims of this study: Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease. Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.

Adjunctive Diode Laser Therapy in Non-Surgical Periodontal Therapy

The goal of this clinical trial is to evaluate the efficacy of adjunctive application of diode laser to mechanical, non-surgical root surface debridement in patients attending periodontal office. The main question it aims to answer is: To compare the clinical effectiveness of adjunctive application of a 940-nm diode laser with root surface debridement to the effectiveness of root surface debridement alone. This study is a split-mouth design, where each quadrant will be randomly allocated to one of the following groups: Control group (root surface debridement - RsD): scaling and root planing alone. Laser group (RsD + laser): scaling and root planing with adjunctive diode laser therapy Quadrants will be randomly allocated to the treatment groups

Evaluation Of The Efficacy Of Subgingival Application Of Lovastatin Gel As An Adjunct To Non-Surgical Treatment Of Periodontitis In Generally Healthy Smokers And Non-Smokers Patients in Central Europe.

The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing). The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant: * a gel containing the medication will be applied under the gum of one tooth * a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth. Before applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working. The study will last six months. Expected results: * all participants will experience an improvement in the condition of their gums after treatment * the effect of treatment will be better in non-smokers than in smokers * the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.

Lactoferrin-Based Oral Care for Periodontal Health in Pregnancy

This randomized controlled clinical trial aims to evaluate the effectiveness of a lactoferrin-based oral hygiene protocol in improving periodontal health during pregnancy. Forty pregnant women between the fourth and eighth month of gestation will be enrolled and randomly assigned to one of two groups. The trial group will undergo professional dental cleaning every three months and will perform home oral hygiene using both a lactoferrin-based toothpaste and a lactoferrin-based mouthwash (Emoform Glic) twice daily. The control group will follow the same schedule of professional dental cleanings but will use only the lactoferrin-based toothpaste (Emoform Glic) at home. The primary objective is to assess the reduction in dental plaque, measured by the Plaque Index (PI). Secondary outcomes include improvements in gingival inflammation, probing pocket depth, clinical attachment level, and other periodontal indices. Participants will be followed for six months, with evaluations conducted at baseline, 1, 3, and 6 months.

Effectiveness of Coenzyme Q10 and Probiotics in Periodontal Therapy During Pregnancy

This randomized controlled clinical trial aims to evaluate the effectiveness of adjunctive coenzyme Q10 and probiotic supplementation (Limosilactobacillus reuteri Prodentis®) in improving periodontal health in pregnant women undergoing non-surgical periodontal therapy. Forty participants will be randomly assigned to two groups: the test group will receive professional oral hygiene every three months along with a coenzyme Q10-based toothpaste and daily probiotic supplementation; the control group will follow the same protocol without probiotics. The primary outcome is the reduction of the Plaque Index (PI), while secondary outcomes include Bleeding on Probing (BoP), Probing Pocket Depth (PPD), Clinical Attachment Level (CAL), gingival inflammation (MGI, PMGI), plaque distribution (PCR%, API), and gingival recession (R). The study duration is 6 months. The goal is to assess whether this combined therapy can promote a balanced oral microbiota and enhance periodontal health during pregnancy.

Investigation of the Relationship Between Periodontitis and Sleep Quality

This project aims to investigate the relationship between periodontitis and sleep quality. Its originality lies in evaluating the association between periodontal status and sleep quality together with salivary interleukin-6 (IL-6), interleukin-6 (IL-10) IL-10, and pentraxin-3 levels. In particular, examining the relationship of sleep quality with biological, psychological, and lifestyle factors through periodontitis and salivary IL-6, IL-10, and pentraxin-3 levels has not been previously studied in the literature. Methodologically, periodontal status will be determined through clinical examination; participants' Pittsburgh Sleep Quality Index and Multidimensional Fatigue Inventory scores will be recorded; and salivary IL-6, IL-10, and pentraxin-3 levels will be measured. The obtained data will be compared using statistical analyses to determine the strength of the relationship between periodontitis severity and sleep quality. From a management perspective, the project will be conducted following approval from the ethics committee. In terms of broader impact, the results are expected to scientifically demonstrate the relationship between periodontitis and sleep quality, contribute to the adoption of a holistic health approach in clinical practice, and increase public health awareness. Additionally, the project is expected to provide a foundation for future research on the relationship between oral health and quality of life.

Longitudinal Oral Health Changes After Head and Neck Radiotherapy

This prospective observational study evaluates how head and neck radiotherapy affects oral health over time. Patients with head and neck cancer undergoing standard radiotherapy are followed from before treatment through multiple post-treatment visits. Changes in periodontal health, dental status, salivary function, and patient-reported oral health quality of life are assessed. The study aims to better understand the long-term oral complications of radiotherapy and to support improved preventive and supportive dental care for cancer patients.

Oral-Spray Bacillus Spore Probiotics for Periodontal Disease Prevention and Supprotive Treatment in the Elderly

Periodontal diseases are strongly associated with dysbiosis of the oral microbiome within the biofilm. Key pathogens, including Streptococcus mutans, Aggregatibacter actinomycetemcomitans, and Porphyromonas gingivalis, contribute to caries progression and periodontal inflammation. Given the limitations of antibiotic use and their potential side effects, probiotics represent a promising biological approach to restore microbial balance and support oral health. In this study, researchers propose that direct application of probiotic spray into the oral cavity is safe and effective in alleviating typical symptoms of periodontal disease, particularly by reducing pathogenic bacterial density. The objective of this study is to evaluate the safety and efficacy of a oral-spray Bacillus spore probiotics (LiveSpo Smile CARE), containing Bacillus subtilis ANA48 and Bacillus clausii ANA39 at a concentration of ≥ 1 billion CFU/mL x 20 mL formulation, for the prevention and supportive treatment of periodontal disease. Study Design: * Sample Size: 90 participants * Study Location: an elderly care center in Hanoi, Vietnam Intervention Description: A total of 90 eligible participants will be randomly assigned to two groups (n = 45 per group). * The Placebo Group will receive 0.9% NaCl physiological saline, spray twice daily (afternoon and evening), with two sprays per application at three sites (both dental arches and the front teeth), totaling six sprays per use, for four consecutive weeks. * The Smile Care Group will receive an oral-spray probiotics containing ≥ 1 billion CFU/mL × 20 mL of Bacillus subtilis and Bacillus clausii (LiveSpo Smile CARE), administered with the same dosage and frequency as the placebo group. All participants will receive blinded, coded spray bottles to ensure objectivity. Both groups will be instructed to use the same standardized toothpaste during the study period. Caregivers will monitor the health status of participants and record relevant information in their medical records. During the study, caregivers will be instructed not to provide any additional probiotic oral care products or the solution contains similar components. Study Duration: 12-18 months.

Association of Periodontal Status and Smoking With Salivary Inflammasome Markers

The aim of this study is to evaluate the relationship between periodontal status and salivary levels of the inflammasomes NOD-like receptor family, pyrin domain containing 3 (NLRP-3), NOD-like receptor family, pyrin domain containing 6 (NLRP-6), NOD-like receptor family, pyrin domain containing 12 (NLRP-12), NOD-like receptor family, CARD domain containing 5 (NLRC-5), interleukin-1 beta (IL-1β) and interleukin-10 (IL-10). Furthermore, this study aims to investigate whether the salivary levels of these inflammasomes may serve as potential diagnostic biomarkers for distinguishing individuals with periodontitis from those without. In addition, the potential role of smoking in modulating the relationship between periodontal status and salivary inflammasome levels will also be explored.