Clinical Research Directory

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

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.

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.

Evaluation of the Safety and Efficacy of SALI-10 Probiotic Lozenges

Gingivitis is among the most common oral conditions, affecting 50-90% of adults globally. It is a reversible inflammatory disease triggered primarily by the accumulation of microbial plaque on teeth and gingival tissues. Standard treatment involves plaque reduction and maintenance of oral hygiene, often supplemented with antimicrobial therapeutics to prevent disease progression. While plaque control remains the cornerstone of prevention, emerging research points to certain beneficial microbes that may protect gingival health. Notably, Streptococcus species have been associated with both antimicrobial and anti-inflammatory activities, suggesting their potential as oral probiotics. Recent investigations have focused on a novel strain, Streptococcus salivarius SALI-10, which produces a lantibiotic called Salivaricin 10. This peptide exhibits unique immunomodulatory properties. In murine models, Salivaricin 10 was shown to enhance neutrophil recruitment and activity while directing monocytes toward the M2 pro-resolution macrophage phenotype, a cell population integral to tissue repair and late-stage wound healing. Such effects highlight the potential of SALI-10 to reduce gingival inflammation while fostering microbial balance. The concept of employing S. salivarius strains in oral health is not entirely new. Other variants isolated from the oral cavities of healthy individuals produce lantibiotics with lanthionine or β-methyllanthionine residues that demonstrate antimicrobial effects against pathogens. Clinical investigations have explored these probiotic strains for halitosis, plaque control, and gingivitis, reporting safety and efficacy. Moreover, salivaricin-producing strains are considered valuable in the ongoing search for alternatives to conventional antibiotics in light of increasing resistance. Understanding the microbial ecology of gingivitis helps contextualize this therapeutic potential. In health, gram-positive bacteria, particularly Streptococcus species, dominate the oral microbiome. Gingivitis involves a shift toward gram-negative periopathogens such as Porphyromonas, Tannerella, Treponema, and Prevotella. This dysbiosis provokes an inflammatory cascade characterized by neutrophil infiltration, tissue damage, and, if unresolved, progression to periodontitis. A recent human experimental gingivitis study revealed distinct host response phenotypes. Participants retaining beneficial Streptococcus species, such as S. sanguinis and S. oralis, experienced reduced periopathogen emergence and milder inflammation. By contrast, participants who lost these protective bacteria demonstrated greater inflammatory severity, underscoring the critical role of Streptococcus persistence in oral homeostasis. Neutrophils, the most abundant immune cells in periodontal tissues, are central to this dynamic. Their numbers increase proportionally with gingivitis severity. Importantly, Health Canada has recently recognized salivary neutrophil activity as a valid biomarker for assessing inflammatory burden and risk of gingivitis or periodontal disease. This regulatory approval highlights the growing emphasis on immune function as both a diagnostic measure and therapeutic target in oral health. Against this backdrop, S. salivarius SALI-10 presents a compelling intervention strategy. Its hypothesized benefits include reducing inflammation via promotion of the M2 macrophage phenotype, suppressing periopathogen growth through competitive exclusion and Salivaricin 10 production, and mitigating halitosis by blocking volatile sulfur compound-producing bacteria. To evaluate these benefits, a proposed study design involves administering a twice-daily lozenge , one in the morning and one in the evening, after brushing a tongue scraping each containing 3 billion CFU of SALI-10 over a four-week period. In summary, gingivitis remains highly prevalent but reversible. Beyond traditional hygiene approaches, microbial therapeutics such as S. salivarius SALI-10 may offer a dual antimicrobial and anti-inflammatory benefit. By promoting immune resolution and reshaping the microbial community, SALI-10 could emerge as a novel probiotic strategy in maintaining oral health and addressing the limitations of conventional antimicrobial therapies.

Application of Ultra-high Frequency Ultrasonography (UHFUS) to the Study of Gingival Tissues

Gingival inflammation triggered by the accumulation of bacterial is the primary risk factor for the development of periodontitis. Clinically, localized signs of inflammation limited to the gingiva, presence of significant bacterial plaque load, and stable attachment levels on the periodontium can be observed in course of gingivitis. The aim of the present study is to compare clinical aspects of gingival tissue in healthy patients versus patients with gingivitis to assess the ultrastructural variations present in course of inflammation. Patients with gingivitis and healthy controls will be enrolled. All patients will undergo ultra-high frequency ultrasonographic scans (70 MHz) of gingival tissue on three areas per dental arch (anterior, middle right, middle left). Gingival thickness, echogenicity, and vascularization assessed through resisitive index will be evaluated.

Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis

This study is a six-week, double-blind, randomized, parallel-group controlled clinical study. The objective of this study is to evaluate the changes to the oral microbiome, inflammatory mediators, gingival health indices and to assess oral tolerance after 4 weeks of twice daily use of differing oral hygiene regimens including mouthwash compared to a control group. A follow-up assessment will be completed 2 weeks after cessation of treatments.

Efficacy of a Toothpaste in Reducing Plaque, Gingivitis, and Gingival Bleeding

To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste

Effect of Morus Nigra Mouthwash on Gingivitis Treatment

The aim of this study is to evaluate the clinical, microbiological, and biochemical effects of Morus nigra (black mulberry) mouthwash when used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with generalized gingivitis. Participants will be randomly assigned to two groups: one receiving SRP only, and the other receiving SRP plus Morus nigra mouthwash twice daily for 14 days. Clinical parameters, cytokine levels in gingival crevicular fluid (TNF-alpha, IL-1beta, IL-10), and subgingival bacterial load will be assessed at baseline, 1 month, and 3 months.

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

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.

Stingless Bee Honey Mouth Rinse on Gingivitis

The currently used chemical mouth rinse, chlorhexidine, was prescribed widely among dental practitioners for its ability to kill bacteria. However, chlorhexidine prolonged use is limited due to its adverse events such as extrinsic tooth staining, taste disturbance, effects on the oral mucosa such as soreness, irritation, mild desquamation, mucosal ulceration, general burning sensation and calculus formation. Thus, an alternative natural active agent is needed to produce mouth rinse with less side effect but offer similar disease prevention effect. This comprehensive four-phase research initiative aims to advance the development and evaluation of a stingless bee honey mouth rinse, particularly focusing on improved formulation and tested in vitro and clinically. In Phase I and II, the mouth rinse development involve the improved formulation by xylitol addition in the formulation with physicochemical assessment such as shelf-life followed by antimicrobial activities against Staphylococcus aureus and cytotoxicity evaluation against oral keratinocytes. Phase III focuses on clinical trial in a pilot study that will be performed on twenty volunteers divided to two groups; control and test group who will be using mouth rinse as adjunctive periodontal therapy agent (TRL 5). Comparative analyses will assess the adjunctive effect of this stingless bee honey mouth rinse in periodontal therapy. A commercially packaged mouth rinse will be designed and produced in collaboration with Bayu Gagah Marketing and will be given to the public as free samples to obtain feedback and validate its further use in the health industry.

A Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth

The clinical study will examine the effects of brushing with randomly assigned test toothpaste on the bacteria on the dental plaque, tongue, cheek, gum surface, and in saliva

NOVOSYN® Quick Versus MONOSYN® Quick Suture Material in Resective Periodontal Surgery

The aim of this study is to prove that Novosyn Quick and Monosyn Quick are equivalent in early wound healing in adult patients undergoing resective periodontal surgery. In order to show equivalence between Novosyn Quick and Monosyn Quick EHS, which is composed of 3 parameters: clinical signs of reepithelization, clinical signs of haemostasis and clinical signs of inflammation, will be calculated for each suture 10 ± 5 days postoperatively and cannot differ more than 2 points. Furthermore, complications, the handling of the suture material, pain, satisfaction of the patient and bacterial contamination of the thread (optional) will also be assessed as secondary objectives.

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.

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.

6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health

The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health. Participants will: * Brush and rinse twice a day with the designated products for 6 months * Visit the clinic once every 3 months after baseline for reassessment.

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.

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.

Validity of a Self-reported Questionnaire for Periodontal Status in a Saudi Population

This observational study will evaluate the accuracy of a self-reported periodontal questionnaire in adults attending screening appointments in Abha, Saudi Arabia. Participants will complete the questionnaire and then undergo a same-visit clinical periodontal examination. The study will compare questionnaire-based results with clinical examination findings to assess diagnostic accuracy and agreement.

Homemade Herbal Mouthwash in Gingivitis. A Randomized Clinical Trial.

Gingivitis is a very common oral disease that may progress to the more destructive periodontitis if not treated. As oral plaque is a key player in gingivitis, plaque control by professional scaling and oral hygiene measures represents the main line of treatment. Among the oral hygiene measures, using chlorhexidine mouthwash is considered the gold standard in mouthwashes. However, due to its side effects, a safer and more acceptable mouthwash is needed. Therefore, this study proposes mouthwashes made of infusion of natural herbs as an alternative.

Motivational Interviewing to Improve Oral Hygiene in Adolescent Orthodontic Patients

This study is being conducted to explore how motivational interviewing (MI), A patient-centered counseling method, can help improve oral health awareness and practices in adolescents undergoing orthodontic treatment. Adolescents often struggle to maintain good oral hygiene during orthodontic care, which can lead to complications such as gum disease, tooth decay, and poor treatment outcomes. Participants in this study will receive brief, structured conversations focused on encouraging them to set goals and take responsibility for their oral health. These interviews are designed to be non-judgmental and supportive, helping the participants explore their own motivations for keeping their teeth and gums healthy during braces treatment. The study will take place at a pediatric dentistry clinic and will involve adolescents aged approximately 14 to 19 who are receiving orthodontic care. The goal is to assess whether this type of communication improves their oral hygiene behaviors and outcomes compared to standard oral health education. Findings from this research may help pediatric dentists and orthodontists improve how they engage adolescent patients in taking care of their oral health.

Dental Biofilm Control During Orthodontic Treatment

Orthodontic appliances can affect changes in the relationships of members of the oral microbiome. Microbiome imbalance can result in oral infections and complicate treatment. The focus is on the microbiological profile of dental biofilm and its control. The effects of metals released by corrosion of alloys for oral use on the microbiome and the extent to which they modify the effectiveness of gingivitis therapy by mechanical and chemical control of biofilm will be investigated. Early and late colonizers of the tooth surface will be analyzed. The condition of gingiva will be assessed, and the results will show the specifics of biofilm and gingiva exposed and unexposed, and differences in the response of individual bacteria to therapy. Molecular biology techniques will be used to quantify the total bacterial biomass (16s rRNA) and the proportion of specific bacterial species within the dental biofilm.

The Antiplaque and Antigingivitis Effect of Pure Green Tea Mouth Wash Compared to Placebo and Essential Oils Mouth Washes

The goal of this clinical trial is to to evaluate the antiplaque and antigingivitis effect of pure green tea mouthwash compared to placebo and essential oils mouthwashes in healthy patients. The main questions it aims to answer are: * Does pure green tea mouthwash effectively reduce dental plaque? * Does pure green tea mouthwash reduce gingival inflammation? Researchers will compare pure green tea mouthwash to Listerine Total Care, Listerine Green Tea, and placebo to see if there is a difference in plaque accumulation and gum inflammation reduction. Participants will be prohibited from using any sort of oral hygiene parctice for the whole study period (3 weeks). Instead, they will rinse with 10 ml of their assigned mouthwash twice daily for 30 seconds. Plaque index, gingival index, and staining index will be examined at multiple intervals and participants will rate their sense of oral freshness and good breath.

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