Clinical Research Directory

Guardians Receiving Information Through Navigators

A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their guardians.

Comparison of Patient-Reported Comfort Between Two Clear Aligner Trimming-Line Designs: A Split-Mouth Study

* The trimming-line design of clear aligners (supragingival versus juxtagingival) is a routine clinical decision whose influence on patient-reported comfort has not been established; available evidence on aligner comfort derives almost exclusively from comparisons with fixed appliances. * This observational, cross-sectional study compares two clear aligner trimming-line designs with respect to patient-reported comfort: a supragingival design, whose edge rests on the marginal gingiva, and a juxtagingival design, whose edge follows the gingival contour without covering it. Because the two designs sit differently against the gingival soft tissue, they may be experienced differently during wear. * Participants are patients already wearing one trimming-line design on one dental arch and the other on the contralateral arch; each participant thus serves as their own control. After a minimum of four weeks of wear, participants complete a 20-item questionnaire once, rating the frequency of defined oral experiences for the maxillary and mandibular arch separately on a three-point ordinal scale (0 = none, 1 = occasional, 2 = frequent). * The questionnaire is anonymous; the design worn on each arch is identified from which of two identical forms a participant completes. Responses for the two designs are compared within each participant. The study evaluates whether trimming-line design is associated with differences in patient-reported comfort.

Reminder-based Educational Mobile Intervention for for Maternal Oral Health Literacy and Preschoolers' Dental Health

The goal of this clinical trial is to determine the effectiveness of educational application based on notification and reminder in improving maternal oral health literacy and the dental and dental health status of preschool children among mother-preschool child pairs (children aged \<7 years) in Pancoran Mas, Depok City. The primary research questions to be addressed in the main trial are: * Does the application group improve mothers' oral health literacy (measured using the REALD-30 questionnaire) more than the printed booklet group? * Does the application group improve children's oral health status, as measured by oral hygiene (Debris Index-Simplified \[DI-S\]) and gingival condition (modified Gingival Index \[mGI\]), more than the printed booklet group? * What is the level of usability (ease of use) of the application as perceived by mothers who use it? The researchers will compare a group of mothers who receive education through the application with a group of mothers who receive education through a printed booklet to determine whether the application produces greater improvements in maternal oral health literacy and children's oral health outcomes. Participants will be asked to: * Complete the REALD-30 questionnaire at baseline (pretest) and at the end of the program (posttest), with a one-month interval between assessments. * Accompany their children for DI-S and mGI examinations at baseline (pretest) and at the end of the program (posttest), with a one-month interval between assessments, conducted by a calibrated dentist. * Receive and study dental health education materials delivered progressively, one chapter per week, through either the application (intervention group) or a printed booklet (control group). Subsequent chapters will be unlocked in the following week. * Complete a daily checklist documenting their child's tooth-brushing activities every morning and evening throughout the study period. * For participants in the application group only: receive daily notifications/reminders and personalized educational messages (based on quiz scores and checklist compliance levels), and complete the Mobile App Usability Questionnaire (MAUQ) at the end of the program.

WhatsApp Messages to Improve Mothers' Oral Health Knowledge and Children's Toothbrushing

Tooth decay is one of the most common health problems in young children in Saudi Arabia. Brushing twice a day with fluoride toothpaste is one of the most effective ways to prevent it, but preschool children cannot do this properly on their own and depend on their mothers to brush for them and to supervise them. Mothers usually receive oral health advice only once, during a dental visit, and a single session may not be enough to change daily habits at home. This study will test whether short oral health messages sent to mothers on WhatsApp, in addition to the usual face-to-face advice, help mothers know more about toothbrushing and help their children brush better. Mothers of children aged 3 to 6 years attending the Pediatric Dentistry Clinics at King Abdulaziz University Hospital in Jeddah will be invited to take part. All mothers will first answer a short questionnaire about what they know about toothbrushing and how their child currently brushes. All mothers will then receive the same 10 to 15 minute face-to-face oral health education session. After the session, each mother will be placed into one of two groups by chance, like flipping a coin. Mothers in the first group will also receive two WhatsApp messages a week for eight weeks, sixteen messages in total, covering how often to brush, how much fluoride toothpaste to use, correct brushing technique, and how to help and supervise their child. Mothers in the second group will not receive these messages. After eight weeks, all mothers will answer the same questionnaire again, and the answers of the two groups will be compared. Taking part involves no dental treatment or procedures beyond the child's normal care, and mothers may withdraw at any time.

Effectiveness of Dental Health Education Methods on Oral Hygiene, Oral Health Care Self-Efficacy and Self-Esteem of Young Orphans

Background: Orphan children are at higher risk of developing oral diseases, compared to non-orphans. They also face various emotional, social, and psychological distresses which affect their general as well as oral health. Aim: To evaluate the effectiveness of three methods of dental health education; namely peer group and game-based health education methods on oral hygiene behavior, oral health care self- efficacy and self-esteem level of a group of institutionalized orphans in Alexandria, Egypt, as compared to conventional health education. Materials and methods: A three-arm randomized controlled clinical trial was compared between peer group based dental health education, game-based dental health education, and conventional dental health education. The study recruited 264 Orphans from non-governmental orphanages in Alexandria, Egypt. Apparently healthy orphans between 7 and 12 years old whose responsible guardians gave consent to allow them to participate in the study will be included. The primary outcome was the improvement in oral hygiene behavior measured by changes in OHI-S and gingival index and the secondary outcome was the change in orphans' self-esteem measured by the Child version of Rosenberg Self-Esteem Scale and the change in orphans' oral health care self-efficacy measured by oral heath behavior self-efficacy questionnaire.

Administration of Oral Probiotic Streptococcus Salivarius K12

The clinical trial is investigating the oral administration of probiotic Streptococcus salivarius K12 in the form of lozenges in healthy adults. The main outcome measures are: * Potential for Streptococcus salivarius K12 to colonise the oral cavity * Effect on other bacteria and Candida albicans in the oral cavity * Possible anti-inflammatory effect Participants will: * Take one lozenge containing Streptococcus salivarius K12 daily for 4 weeks * Attend 3 dental check-ups (before starting the probiotic treatment, and after 4 and 8 weeks) * Collect their own saliva samples in accordance with a sampling schedule

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.

Predication of Arterial Stiffness in Healthy Adults by Oral Health and Chewing Assessments

INN.oral.HEALTH is an sub-study embedded in the Innsbruck Health Promotion Program (INN.HEALTH). The study investigates whether oral health, oral structure, and oral function provide additional information for understanding vascular health in adults from the general population. Cardiovascular and cerebrovascular diseases, such as heart attack and stroke, remain major causes of death and disability. Many risk factors, including blood pressure, blood lipids, blood sugar, smoking, physical activity, sleep, and diet, are already known to influence vascular health. However, oral health may also be related to vascular risk. Conditions such as tooth loss, impaired chewing, reduced tongue strength, or oral disease burden may reflect or contribute to general health and vascular ageing, but their additional value in prevention programs is not yet well understood. The main hypothesis of this study is that a standardized oral structure and function profile can improve the explanation of central arterial stiffness beyond established cardiovascular risk factors and lifestyle-related health metrics (INN.HEALTH study). Central arterial stiffness will be assessed using carotid-femoral pulse wave velocity, a marker of vascular ageing and cardiovascular risk. Participants will undergo a single oral assessment during Visit 4 of the INN.HEALTH study. The assessment includes screening of oral health status, dentition, bite force, tongue pressure, chewing efficiency, chewing and swallowing performance, questionnaires on oral health-related quality of life and food avoidance, and measurement of masseter muscle thickness. The study does not involve any treatment. The results may help clarify whether oral structural and functional markers can contribute to future vascular risk assessment and prevention strategies in the general adult population.

Oral Health Education for Pregnant Women

The goal of this research is to investigate oral health knowledge in pregnant women receiving care at Hospital La Fe and to see whether a one-time informational intervention improves this knowledge. The main questions this research aims to answer are: What is the level of oral health knowledge among pregnant women attending Hospital La Fe? Does a one-time informational intervention, delivered through a printed leaflet, improve oral health knowledge during pregnancy? What factors are related to differences in oral health knowledge among pregnant women? Participants are pregnant women receiving care at Hospital La Fe. They will: Complete a questionnaire about their oral health knowledge. Receive a printed informational leaflet about oral health during pregnancy. Complete the same questionnaire again after a period of time to see if their knowledge has changed. Researchers will compare answers before and after the leaflet is provided to see whether oral health knowledge improves. They will also explore which personal or social factors are linked to different levels of oral health knowledge.

Structural and Intermediary Social Determinants of Oral Health Among Egyptian Women

Globally, there is substantial evidence indicating that low household income, lack of education, poor living conditions and inadequate psycho-social social support are potential risk factors for morbidity and premature death. Despite that, worldwide, there is scarcity in evidence on potential social determinants of oral health among different population groups.The study aims To identify the potential social determinants with an influence on oral health status of Egyptian women.

Large Language Models for Dental Radiology Report Generation From Structured Textual Data

The purpose of this observational methodological study is to evaluate whether large language models can transform structured dental radiology data into clear narrative radiology reports. Large language models are computer programs that can generate text from information provided to them. In this study, the input will consist of organized dental radiology findings, such as chart-style or diagram-based information about teeth and surrounding structures. Dental radiology reports are used by dentists and other health care providers to understand imaging findings and support clinical documentation. Preparing narrative reports may be time-consuming, and the wording of reports may vary between clinicians. This study will examine whether language-model-assisted report generation can produce reports that are complete, accurate, understandable, and clinically useful. The study will compare reports generated with support from large language models with traditionally prepared reports. Researchers will also assess how the wording of the prompt and selected model parameters influence report quality. In addition, the study will analyze errors and safety risks in generated reports and evaluate whether such a system could be practical in a dental radiology workflow. The language model will not make treatment decisions, and generated reports will be used for research evaluation only.

Determining the Viability a Lozenge Dosage for Probiotics

Gingivitis is an oral disease condition affecting 50% to 90% of adults globally. Gingivitis is a reversible inflammatory condition caused by the accumulation of dental plaque and the associated disruption of the host-microbial homeostasis. During gingivitis, the microbial community shifts from gram-positive health-associated bacteria, to gram-negative disease associated species. This shift triggers inflammatory responses, leading to tissue damage and, in some cases, progression to periodontitis. A promising area of oral health is treating the oral cavity with gram-positive probiotics to improve oral health. One promising candidate is S. salivarius SALI-10. Typically oral probiotics are dosed to the oral cavity using lozenges. This study is a pre-clinical Phase 0 trial to determine is a lozenge is a viable dosage form for the delivery of salivarius SALI-10 oral probiotics.

Periodontal Biocompatibility of Pediatric Crowns

Different full-coverage crown materials are widely used in pediatric dentistry for the restoration of primary teeth with extensive substance loss. Since these restorations remain in close contact with gingival tissues for prolonged periods, they may influence periodontal health depending on their surface characteristics, marginal adaptation, and biological properties. The aim of this study was to evaluate the effects of stainless steel crowns (SSC), prefabricated zirconia crowns (PZC), and fiber-glass crowns (FGC) on periodontal health in children using both clinical periodontal parameters and gingival crevicular fluid (GCF) biomarkers, including IL-1β and MMP-8, within a split-mouth study design.

Effect of Benzydamine Hydrochloride Mouthrinse on Plaque Accumulation in Periodontally Healthy Female Subjects

The goal of this clinical trial is to evaluate the effect of a mouthrinse containing an active ingredient benzydamine hydrochloride in the absence of daily oral hygiene. The study includes periodontally healthy female subjects and experimental phase will last for three days. Plaque accumulation is the primary evaluated outcome, measured by a particular periodontal index called Plaque Control Record (PCR). Gingival inflammation (bleeding) is the secondary evaluated outcome, measured by a particular periodontal index called Bleeding on Probing (BoP). Researchers will compare benzyadamine hydrochloride mouthrinse to a placebo (a look-alike substance that contains no active ingredient) mouthwash to see whether benzydamine hydrochloride use results in greater plaque accumulation.

Efficacy of Devices in Maintaining Oral Health and Managing Periodontal and Interproximal Tissues

The aim of the study was to assess the acceptability of the assisted individual and compliance with home use, as well as their clinical impact on the plaque index (PI) and bleeding on probing (BOP), with monthly reassessments allowing for continuous monitoring of all parameters.

Validation Of The Turkish Version Of The Oral Assessment Sheet

The aim of this observational study is to evaluate the validity and reliability of the Turkish version of the Oral Assessment Sheet (OAS). The OAS is a clinical assessment tool developed to evaluate oral health conditions such as lips, tongue, mucosa, saliva, swallowing, and voice. This study will investigate whether the Turkish version of the OAS is a valid and reliable tool for assessing oral health status in clinical practice. Participants will undergo oral assessment using the Turkish version of the OAS. Statistical analyses will be performed to determine the validity and reliability of the scale. The results of this study are expected to provide a standardized oral assessment tool that can be used in Turkish clinical settings.

Food Typologies and Multidimensional Phenotyping of Elderly in Auvergne-Rhône-Alpes (Part'AGE)

To better understand how diet influences health during aging, the French National Research Institute for Agriculture, Food and the Environment (INRAE) is working with the Gérontopôle Auvergne-Rhône-Alpes on a project called Part'AGE. Part'AGE is a participatory research project where researchers want to recruit 1,000 people aged between 55 and 75 years, men and women, living in Auvergne-Rhône-Alpes in urban or rural areas. The goal is to study eating habits and state of health. To do this, researchers will examine many factors that can influence them, such as physical activity, overall health, consumption patterns or territories. Researchers will collect detailed information to classify participants into different groups (food typologies) based on their eating habits and state of health. With this distribution, the goal is to be able to give each group personalized nutritional advice to age in better health. To participate in the study, the participants will need to collect a few drops of blood from the end of the finger, a urine sample, and do some tests (mobility, oral health). It will also be necessary to fill out questionnaires on eating habits, physical activity, and other aspects that may influence health. The benefices for to participants will be to contribute to nutrition research and to receive personalized feedback and advices on eating habits.

Egyptian Dental Professionals' Perspectives on the Oral Microbiome and Exosomes

This study employs a structured, validated questionnaire as the index test to objectively assess dental professionals' knowledge of the oral microbiome and exosomes, alongside attitudes, readiness, and perceived barriers. The primary aim is to develop and compare Microbiome Knowledge Scores (MKS) and Exosome Knowledge Scores (EKS) across dental specialties, workplace settings, and years of practice. Secondary aims include evaluating attitudes and perceived barriers, assessing the relationship between self-rated and objective knowledge, and identifying predictors of higher knowledge levels. The study tests the null hypotheses that MKS/EKS do not differ across demographic or practice characteristics and that self-rated knowledge does not correlate with objective knowledge.

Ecofriendly Versus Nylon Tooth Brushes on Cariogram Outcomes

The goal of this clinical trial is to evaluate the effectiveness of an eco-friendly toothbrush compared to a conventional nylon-based toothbrush on cariogram parameters in children and adults. It will also assess the impact of toothbrush type on caries risk factors. The main questions it aims to answer are: Does the use of an eco-friendly toothbrush improve cariogram parameters compared to a nylon-based toothbrush? Does toothbrush type influence overall caries risk in children and adults? Participants will: 1. Be randomly assigned to use either an eco-friendly toothbrush or a nylon-based toothbrush 2. Use the assigned toothbrush as part of their daily oral hygiene routine for the study period 3. Attend scheduled follow-up visits for clinical examination and cariogram assessment

Oral Indicators for ED Screening

The main objective of this research project is to explore the capability of a standardized, evidence-based study tool (the OHEDs Checklist) in the early identification of oro-dental manifestations potentially indicative of an eating disorder. The secondary objective is to evaluate the sensitivity and specificity of the OHEDs Checklist in comparison with validated screening instruments for eating disorders, namely the ESP, SCOFF and DEQ questionnaires.

The Use of Functional Confections in Promoting Oral Health

In areas of the world where populations are undernourished poor oral health is prevalent. Diets rich in fruit and vegetables are thought to have many health benefits including reducing the risk of oral cancer or gum disease. In particular fruits such as strawberries contain many different compounds which may be responsible for these proposed health benefits. From this study, the researchers hope to gain information about how the tissues in the mouth absorb strawberry gummies in a population of habitually smoking and never smoking men and women. The researchers will measure inflammation hormones in your saliva and urine and the genes in your mouth and blood. Two different strawberry gummies will be tested in this study. The strawberry gummies were developed at OSU in the Department of Food Science and Technology. One type of strawberry gummy will contain freeze-dried whole strawberries while the other type will have no fruit. In total the eight pieces of strawberry gummies that you will consume in one day will be at most equal to 1 cup of whole strawberries. The research team believes the two strawberry gummies may be digested and absorbed differently and that components in the strawberry gummies may be helpful for oral health.

AI Toothbrush and Visual Pedagogy to Improve Oral Hygiene in Children With Autism Spectrum Disorder

This randomized clinical trial evaluates the effectiveness of an AI-enabled electric toothbrush and visual pedagogy materials in improving oral hygiene among children with autism spectrum disorder (ASD). The study compares plaque control, gingival health, and adherence between children using a manual toothbrush with visual pedagogy support and those using an AI-enabled electric toothbrush with app-based monitoring.

Parental Perception of Oral Health-Related Quality of Life in Sudanese Refugee vs. Egyptian Children

This cross-sectional analytical study aims to assess and compare parental perceptions of oral health-related quality of life (OHRQoL) among Sudanese refugee children and Egyptian children aged 6-12 years living in Egypt. The study will include 192 child-parent pairs (96 Sudanese refugees and 96 Egyptians). Data will be collected via a validated Arabic questionnaire adapted from the Child Oral Health Impact Profile (COHIP) and clinical oral health examinations using DMFT/dmft indices, Gingival Index, and Plaque Index. The study seeks to identify disparities in oral health, parental awareness, and access to dental care services, thereby informing future community-based interventions and public health policies targeting vulnerable populations such as refugee children.

Evaluating the Impact of Various Dietary Nitrate Supplements on Oral Health

This study aims to investigate the effects of different dietary nitrate supplements, versus placebo, on microbiological and immunological markers associated with oral health in people aged 18-65 years. The main research questions are: * How do different dietary nitrate supplements (beetroot crystals vs. beetroot juice) affect oral health markers, including salivary pH and oral microbiome composition? * What is the acceptability and ease of integrating one of dietary nitrate supplements, made from beetroot but processed as freeze dried crystals or juice, into the daily diet? To answer these questions, the study will compare results from three groups of participants, who will be randomly assigned to one of the following study arms: Group 1: The control group will consume a placebo beetroot supplement completely free of nitrate in juice form. Group 2: The beetroot juice group will consume a beetroot supplement standardised to contain \~ 400 mg of nitrate in juice form. Group 3: The beetroot crystals group will consume a beetroot supplement standardised to contain \~400 mg of nitrate in freeze dried crystal form. The study will follow a randomised, single-blind, placebo-controlled, parallel design, and the intervention will last for four weeks. Data will be collected by providing pre- and post-intervention saliva samples tongue swabs, and various questionnaires will be completed at baseline and at the end of the study. In addition, at the end of the second week of the intervention period, participants will be asked to collect a saliva sample over three consecutive days at home.