Clinical Research Directory

Artificial Intelligence for the Diagnosis of Gingivitis

this study aims to use AI to diagnose the stages of gingivitis

Evaluation of Mandibular Bone Microstructure Changes After Periodontal Treatment (M-BONE Study)

This prospective study evaluates how non-surgical treatment for gum disease affects the bone of the mandible. Gum disease (periodontitis) can lead to changes in the bone supporting the teeth, but these changes are not always easy to detect with routine clinical examination. prospectively collect clinical and radiographic data from patients with moderate and severe gum disease (Stage II and Stage III periodontitis), as well as individuals with gingivitis, were analyzed. All participants had received standard periodontal treatment as part of routine care. Radiographic images taken before treatment and 6 months after treatment were examined using fractal analysis, a method used to assess bone structure. The results of this study may help improve understanding of how periodontal treatment influences bone structure and may support the use of radiographic analysis as a tool for monitoring treatment outcomes.

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.

Video vs. Model-Based Oral Hygiene Instruction in Gingivitis Patients

This randomized, single-blind clinical trial aims to evaluate the short-term effectiveness of two different oral hygiene instruction (OHI) methods-video-assisted instruction versus traditional 3D model demonstration-on periodontal clinical parameters in patients diagnosed with gingivitis. A critical secondary objective of this study is to investigate the predictive role of patients' baseline Oral Hygiene-Related Self-Efficacy (OHSE) on the extent of clinical healing, and to assess changes in patient-reported subjective gingival health using a Visual Analogue Scale (VAS). A total of 80 patients undergoing standard Phase 1 periodontal therapy (scaling and root planing) are randomly assigned in a 1:1 ratio to either the video instruction group or the model instruction group. Periodontal clinical indices, including Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing (BOP), alongside patient-reported outcomes, are recorded at baseline and at a one-month follow-up by a blinded examiner. The primary hypothesis is that video-based instruction is non-inferior to conventional model-based instruction in improving clinical parameters. Furthermore, the study hypothesizes that a patient's baseline self-efficacy level-independent of the educational method received-significantly predicts the reduction in periodontal inflammation and bleeding scores.

A Study to Investigate the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health

The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w/w) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate gingivitis.

A Multicentre Randomised Controlled Trial Evaluating the Efficacy of the SMILE™ Module for Improving Short-term Periodontal Outcomes, Compliance, and Acceptability Among Clinical Dental Students

This multicentre randomised controlled trial aims to evaluate the efficacy and safety of the SMILETM (Siwak Method for Integrated Lifestyle Enhancement) module in improving short-term periodontal outcomes, oral hygiene behaviour, and safe siwak practice among clinical dental students. Conventional toothbrushing will serve as the control intervention. Eligible participants will be randomly assigned to either the SMILE intervention group or the conventional toothbrushing control group. Both groups will receive professional oral prophylaxis, standardised oral hygiene education, structured training according to their allocated intervention, and digital monitoring throughout the 21-day study period. The study will assess changes in plaque accumulation, gingival health, and bleeding on probing, as well as participant compliance, behavioural outcomes, acceptability of the SMILE module, and intervention-related adverse events. It is hypothesised that the SMILE module will effectively improve short-term periodontal outcomes, promote better compliance with the recommended oral hygiene practice, and achieve favourable acceptability while maintaining participant safety.

Effect of Individually Trained Oral Prophylaxis (iTOP) on Gingival Health in Orthodontic Patients

This randomized controlled clinical trial aims to evaluate the effectiveness of individualized oral hygiene education using the Individually Trained Oral Prophylaxis (iTOP) method compared with conventional oral hygiene instruction using model demonstration and video-based education in orthodontic patients diagnosed with gingivitis. Sixty orthodontic patients underwent professional mechanical plaque removal and received oral hygiene instruction using calibrated interdental brushes. Participants were randomly assigned to either the iTOP training group or the conventional education group. Clinical outcomes including Approximal Plaque Index (API), Gingival Index (GI), and Full Mouth Bleeding Score (FMBS) were assessed at baseline and after three months to determine the effectiveness of the educational interventions on plaque control and gingival health.

Powered Toothbrush Versus Manual Toothbrush on Plaque and Gingivitis After a Six-Week Period of Home Use

The goal of this clinical trial is to learn if powered toothbrushing is more effective than manual toothbrushing in removing dental plaque. It will also learn about the safety of power toothbrushing. The main questions the study aims to answer are: Does power toothbrushing remove more dental plaque than manual toothbrushing? Does power toothbrushing reduce symptoms of gingivitis better than manual toothbrushing? Participants will: Brush their teeth twice a day with either a manual or power toothbrush Visit the clinic twice during the study, after two and six weeks after the study starts. Keep a diary of when they brushed their teeth

Oral Health Education and Message Framing Effect on Oral Health Status of Refugees in Egypt

Refugees, facing forced displacement and often exposed to traumatic experiences, represent a vulnerable population with unique healthcare needs. Oral health is considered a prominent factor that contributes to quality of life. Therefore, this study aim at assessing the effect of message framing on enhancing oral health practices in a group of refugees in Alexandria, Egypt. A three-arm cluster randomized controlled clinical trial will compare a gain-framed mobile text messages group, a loss-framed mobile text messages group, and a control group. The primary outcome is the improvement in oral health practices measured by changes in dental plaque and secondary outcome is to assess change in oral health-related quality of life. In addition, oral health knowledge, attitudes, and practices of refugees will be assessed.

A Person-centered, Theory-based, Intervention - Method Development Through the Integration of Digital Technology.

Studies have shown that Swedish adolescents have poor oral hygiene and with high prevalence of gingivitis. Therefore, more effective preventive programs in dental care are needed. The project aims to examine whether a health application and follow-up person-centered digital meetings can serve as support in person-centered and theory-based behavioral interventions to promote and maintain positive oral health habits.

Assessment of Oral Health-Related Quality of Life in Preschool-Aged Children in Alto Alentejo

The observational study aims to improve understanding of Oral Health-Related Quality of Life (OHRQoL) among preschool children in the District of Portalegre, Portugal, by examining the roles of sociodemographic, behavioral, and parental psychosocial factors, as well as the child's oral health status. The study seeks to answer the following main research question: How do sociodemographic, behavioural, parental psychosocial factors, and the child's oral health status influence the Oral Health-Related Quality of Life (OHRQoL) of preschool children in the District of Portalegre?

Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools

Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three to fifty percent of adult population presented at least one untreated caries and more than 50% of French population are affected by severe periodontitis. These diseases affect dental organ or periodontal attached system but could have negative impact on general health, quality of life, word and individual well-being. Association between chronic diseases as diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well investigated. Dental and periodontal diagnosis is dependent of various clinical parameters time consuming and dependent operator. It represents a public health challenge. Informatic analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today, any software or algorithm allow automatized detection, clinical qualitative or quantitative indices recording while these informations are present in numeric models

Evaluation of Gingival Crevicular Fluid Cytokine Profiles in Children and Young Adults With Gingivitis

This prospective observational case-control study aims to compare gingival crevicular fluid (GCF) biomarker profiles between children and young adults diagnosed with gingivitis. A total of approximately 80 systemically healthy participants will be recruited and divided into two groups: children aged 8-12 years and young adults aged 15-24 years. Individuals aged 13-14 years will be excluded as they represent a transitional pubertal period characterized by significant hormonal fluctuations that may influence inflammatory responses and confound biomarker levels. Clinical periodontal parameters including gingival index, plaque index, bleeding on probing, and probing depth will be recorded. In addition, GCF samples will be collected from a standardized tooth and analyzed for levels of IL-1β, TNF-α, IL-10, and MMP-8 using enzyme-linked immunosorbent assay (ELISA). The primary objective of the study is to evaluate and compare inflammatory and anti-inflammatory cytokine profiles between the two age groups. The findings may contribute to understanding age-related differences in gingival inflammatory responses and the potential role of hormonal transition in periodontal disease expression during childhood and early adulthood.

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.

Xylitol and the Prevention of Periodontal Disease and Preterm Birth Trial

The ground-breaking Prevention of Prematurity and Xylitol (PPaX) cluster randomized controlled clinical trial was conducted in Lilongwe, Malawi and enrolled approximately 10,069 pregnant individuals seeking to evaluate the impact of xylitol-containing chewing gum compared to no chewing gum on reducing the occurrence of maternal periodontal disease, preterm birth, and low birthweight offspring. The premise of this study centers upon the numerous publications supporting a strong association between maternal periodontal disease and preterm birth. Given that xylitol-containing chewing gum is considered a prebiotic and known to reduce cariogenic and periodontopathic bacteria, the study evaluated and discovered a statistically significant reduction in maternal periodontal disease, preterm birth, and low birthweight offspring among pregnant individuals who chewed xylitol-containing chewing gum. While PPaX demonstrated the efficacy of xylitol to reduce preterm birth (PTB), the study had important limitations: (a) PPaX was an unblinded cluster-randomized study with only 8 clusters, 4 with xylitol-containing chewing gum and 4 without any gum (not placebo-controlled); (b) PPaX used a suboptimal dose of 2 grams of xylitol daily which may have reduced the effectiveness of the intervention given that recent literature suggests 5-10 grams/day more effectively improve oral health; and (c) PPaX did not evaluate infant mortality nor early neurodevelopmental outcomes. Notably, reducing fetal exposure to periodontal disease (PD) as well as PTB may improve neurodevelopmental outcomes for offspring as both prematurity and fetal exposure to inflammation are well-documented risk factors for neurodevelopmental delay (NDD) and infant mortality. The investigators will conduct a double-blind, placebo-controlled, individually randomized clinical trial with 3 arms among Malawian pregnant individuals (n=6000) at \<20 weeks of pregnancy with the co-primary outcomes being the incidence of PTB and low birthweight offspring. The 3 study arms (n=2000 each) will be (a) an optimized dose of xylitol-containing chewing gum (6.4 grams/day), (b) the PPaX trial xylitol dose (2.1 grams/day), or (c) flavored sorbitol gum base (placebo control). This trial overcomes the PPaX trial's limitations and will definitively answer whether xylitol prevents PTB in Malawi. The investigators will additionally collect biospecimens from a random sampling of the participants for biobanking for later analysis of inflammatory and microbiome alterations that may occur with xylitol exposure compared with placebo. The investigators hypothesize that pregnant individuals who chew xylitol-containing chewing gum will have a significant reduction in periodontal disease metrics at 28-30 weeks' gestation (e.g. bleeding on probing) as well as offspring with improved neurodevelopmental outcomes as assessed by the Bayley Scales of Infant and Toddler Development 4th edition and reduced risk of adverse pregnancy outcomes including preterm birth.

Relationship Between Periodontal Inflammation Severity and Pan-Immune System Inflammation Value

This cross-sectional observational study aims to evaluate the relationship between periodontal inflammation severity and the Pan-Immune-Inflammation Value (PIV) in systemically healthy adults. A total of 160 participants will be recruited from the Department of Periodontology, Faculty of Dentistry, Bolu Abant Izzet Baysal University. Clinical periodontal parameters and Periodontal Inflamed Surface Area (PISA) will be recorded, and their association with PIV calculated from complete blood count parameters will be analyzed.

To Assess the Efficacy of Two Brushing Regimens: in the Reduction of Established Dental Plaque and Gingivitis.

Triple Blinded Randomized Clinical trial study to assess the efficacy of two brushing regimens: 1) a toothpaste containing stannous fluoride and a standard manual toothbrush as compared to 2) a regular fluoride toothpaste and standard manual toothbrush in the reduction of established dental plaque and gingivitis.

Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash

Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after two weeks, six weeks and three months of product use. All subjects will be followed for adverse events throughout the study

Effect of Probiotics on the Periodontal Status of Orthodontic Patients

Gingival inflammation (gingivitis) is commonly reported in teenagers with fixed orthodontic devices (FOD). Indeed, FODs promote the accumulation of plaque and interfere with the efficacy of tooth brushing. According to in vitro and in vivo studies, the administration of oral probiotic bacteria including Lactobacillus reuteri may reduce the number of periodontal pathogens in saliva and dental plaque. A recent systematic review shows a positive effect of probiotics in addition to tooth brushing in the treatment of periodontitis. However, there is insufficient data regarding the effect of probiotics in the prevention of gum diseases. The aim of this double-blind randomized placebo-controlled study is to assess the effect of probiotics, in addition to dental brushing, on gum inflammation and the composition of the oral microbiota in teenagers with fixed orthodontic appliances

Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption

This prospective cross-sectional clinical study aims to investigate the relationship between circadian rhythm disruption and periodontal inflammation by evaluating circadian clock protein levels, inflammatory (IL-1beta) and anti-inflammatory (IL-10) cytokine levels in gingival crevicular fluid (GCF) of individuals with and without circadian rhythm disruption. Participants aged 20-50 years will be classified into four groups based on their circadian rhythm status (disrupted/normal) and gingival health status (gingivitis/healthy). Clinical periodontal parameters including plaque index, gingival index, bleeding on probing, and probing depth will be assessed. Circadian rhythm status will be determined using validated questionnaires (Morningness-Eveningness Questionnaire and Munich Chronotype Questionnaire). Night-shift workers will represent the circadian rhythm disruption group. GCF samples will be analyzed for circadian clock proteins (BMAL-1, CLOCK, PER-1, PER-2, PER-3, CRY-1, CRY-2, REV-ERB-beta, MTNR1B) and cytokines (IL-1beta, IL-10) using ELISA. Serum cortisol and melatonin levels will be measured for biochemical verification of circadian rhythm status. Gingivitis groups will receive standard periodontal treatment and be re-evaluated at 2 weeks post-treatment. A total of 116 participants (29 per group) are planned for enrollment.

Evaluation of the Effect of the Toothpaste on Delicate Gums

The goal of this study is to learn if a toothpaste works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is: • Does the toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see if it works to improve gingivitis. Participants will: * Use assigned toothpaste daily for 4 weeks * Visit the clinic on the established days during 4 weeks for check-ups and evaluation

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.

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.