Clinical Research Directory

Evaluation of PTHrP, RANKL, and OPG Levels in Periodontal Health and Diseases

This observational study aims to evaluate the levels of specific biological markers-Parathyroid Hormone-Related Protein (PTHrP), RANKL, and Osteoprotegerin (OPG)-in the gingival crevicular fluid of individuals with different gum health conditions. The study includes a total of 81 participants, divided equally into three groups: 27 with healthy gums, 27 with gingivitis, and 27 with periodontitis. During a routine dental visit, participants undergo a standard periodontal examination to measure clinical signs such as plaque levels, gum bleeding, and pocket depths. Additionally, small sterile paper strips are gently placed in the gum crevices for 30 seconds to collect fluid samples. These fluid samples are then analyzed in a laboratory to understand how these specific proteins relate to gum health and the severity of gum disease.

The Efficacy of a Battery Toothbrush in the Reduction of Established Plaque and Gingivitis

A clinical research study design to compare the effectiveness of a battery toothbrush and dentifrice in reducing gingivitis and dental plaque in adults.

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.

Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis

The goal of this clinical trial is to learn if daily oil pulling with coconut oil or sesame oil works as effectively as a standard mouthwash to treat gum swelling and redness (gingivitis) in adults aged 18 to 55 years. The main questions it aims to answer are: * Does daily oil pulling with virgin coconut oil or sesame oil reduce dental plaque buildup as effectively as 0.2% chlorhexidine mouthwash over an 8-week period? * Does oil pulling reduce gum inflammation, bleeding, and tongue coating while avoiding common mouthwash side effects such as tooth staining? * Does oil pulling improve oral health-related quality of life and overall patient satisfaction? Researchers will compare three groups - participants using coconut oil, participants using sesame oil, and participants using 0.2% chlorhexidine mouthwash - to evaluate changes in oral health over 8 weeks. Participants will: * Receive professional dental cleaning (scaling) and standardized toothbrushing instructions at the start of the study. * Swish 10 mL of their assigned oil for 7 minutes once daily in the morning on an empty stomach, or rinse with 10 mL of 0.2% chlorhexidine mouthwash for 1 minute at night, every day for 8 weeks (56 days). * Visit the dental clinic at baseline (Day 0), week 4 (Day 28), and week 8 (Day 56) for clinical oral exams, salivary pH testing, and short surveys on comfort and satisfaction. 2\. Clinical Trial Registry (CTR) Protocol Registration Fields Registry Field Name Protocol Value / Description Official Title Effectiveness of Oil Pulling Using Oils in Comparison with Mouthwash for Gingivitis: A Single-Blind Randomized Control Trial Brief Title Effectiveness of Oil Pulling vs. Chlorhexidine Mouthwash for Gingivitis Study Type Interventional (Clinical Trial) Primary Purpose Treatment Allocation Randomized (1:1:1 ratio across 3 parallel arms) Intervention Model Parallel Assignment Masking Single Blind (Outcome Assessor blinded) Target Enrollment 45 participants (15 per arm, adjusted for 20% dropout) Condition / Disease Gingivitis / Plaque-Induced Gingival Inflammation Age Range 18 Years to 55 Years Sex / Gender All (Males and Females) Accepts Healthy Volunteers No (Requires clinically diagnosed plaque-induced gingivitis) Inclusion Criteria Clinically diagnosed gingivitis; Community Periodontal Index of Treatment Needs (CPITN) Grade 1 or 2; presence of at least 10 natural teeth. Exclusion Criteria CPITN Grade 0, 3, or 4; chronic illnesses (diabetes, hypertension, cardiovascular, renal/hepatic dysfunction); pregnancy/lactation; tobacco/smokeless tobacco users; recent antibiotics, antimicrobial mouthwashes, or scaling within last 3 months; known allergy to sesame oil, coconut oil, or chlorhexidine. Experimental Arm 1 (Coconut Oil) 10 mL coconut oil swished/pulled once daily in the morning on an empty stomach for 7 minutes for 56 days. Experimental Arm 2 (Sesame Oil) 10 mL sesame oil swished/pulled once daily in the morning on an empty stomach for 7 minutes for 56 days. Active Comparator Arm (0.2% Chlorhexidine) 10 mL 0.2% chlorhexidine digluconate mouthwash rinsed for 1 minute once daily at night after brushing for 56 days. Primary Outcome Measure Change in Silness and Loe Plaque Index (PI) at Baseline (T1), Day 28 (T2), and Day 56 (T3).

A Clinical Study to Evaluate the Efficacy of a Cetylpyridinium Chloride Mouthwash in Improving Gingival Health and Reducing Plaque Accumulation

The aim of this 12-week clinical study is to evaluate the ability of an experimental mouthwash, containing 0.085 percent (%) Cetylpyridinium chloride (CPC) as an adjunct to toothbrushing with a regular fluoride toothpaste, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste alone in participants with plaque-induced mild to moderate gingivitis.

Salivary and GCF Biomarkers in Periodontal Health, Gingivitis and Periodontitis

This observational cross-sectional study aims to compare the levels of irisin, interleukin-6 (IL-6), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-α) in saliva and gingival crevicular fluid (GCF) among individuals with periodontal health, gingivitis, and periodontitis. Biomarker concentrations will be measured using human-specific ELISA kits. The study seeks to evaluate the diagnostic potential of these markers and to contribute to a better understanding of the inflammatory-metabolic axis in periodontal disease.

St. John's Wort Oil Versus Chlorhexidine Mouthwash for Gingival Problems After Rapid Maxillary Expansion

The goal of this clinical trial was to learn whether St. John's wort (Hypericum perforatum) oil helps gum healing in children and adolescents aged 11 to 16 years after treatment with a rapid maxillary expansion appliance. This appliance widens the upper jaw, but it covers a large part of the palate and makes cleaning difficult, which can cause gum redness, bleeding, swelling and pain after the appliance is removed. The main questions it aimed to answer were: Does St. John's wort oil improve gum health after the appliance is removed? Does it reduce pain in the days after appliance removal? Researchers compared St. John's wort oil with chlorhexidine mouthwash, a commonly used oral antiseptic, and with a control group that used no antiseptic product. Participants: Were randomly assigned to one of three groups after removal of the expansion appliance Used St. John's wort oil as a mouthrinse or chlorhexidine three times a day for 7 days, or used no product (control group) Had their gums examined before the appliance was placed, when it was removed, and 7, 14 and 30 days later Recorded their pain level on a 0-10 scale on several days after appliance removal

The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population

The aim of this study is to evaluate the efficacy of the test toothpaste compared to a regular fluoride toothpaste in the reducing gingivitis and plaque accumulation in Chinese participants with plaque-induced gingivitis.

Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years

Overweight and obesity, as well as periodontitis, are common public health problems with increasing prevalence. Both conditions may be linked through shared mechanisms involving chronic low-grade systemic inflammation. Numerous studies have reported an association between elevated body mass index (BMI) and periodontitis, particularly among younger and working-age populations. However, data regarding Thai adults under the age of 60 remain limited. Therefore, this study aims to determine the prevalence of high BMI and periodontitis among Thai adults aged 18-59 years and to identify factors associated with these conditions. The findings may provide useful information for improving awareness and supporting the prevention of both periodontal and general health problems in this population.

Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste

The goal of this clinical trial is to learn if Nanibiofusion Gingival Gel (NBF) is able to reduce dental plaque and gum inflammation in adults. The trial will also check whether daily use of NBF Gingival Gel causes tooth staining over time. The main questions it aims to answer are: * Does NBF Gingival Gel reduce dental plaque (a sticky film of bacteria on teeth)? * Does NBF Gingival Gel reduce gum inflammation? * Does NBF Gingival Gel cause tooth staining? * Are participants satisfied with the product's taste, texture, and ease of use? Researchers will compare NBF gel to a placebo gel (a look-alike gel that contains no active ingredients), and Colgate toothpaste (a standard fluoride toothpaste). This will show if NBF gel is able to reduce plaque and gum inflammation. Participants will: * Be assigned to one of three groups and use their assigned product twice daily for 3 months. * Receive a professional teeth cleaning at the start of the study, before using any product. * Visit the clinic at baseline and at 1, 2, and 3 months for plaque, gum health, and staining checks. * Receive a complimentary professional cleaning at the final visit to remove any staining. * Rate the product's taste, texture, and ease of use.

Efficacy of SALI-10 Oral Probiotics in Experimental Gingivitis

Gingivitis is among the most prevalent oral diseases worldwide, affecting an estimated 50-90% of adults. It is a reversible condition primarily caused by microbial plaque accumulation on teeth and gingival surfaces, which triggers inflammation. Standard care emphasizes plaque reduction through oral hygiene, and research shows gingivitis can be reversed once hygiene resumes. The classic experimental gingivitis (EG) model developed in 1965 by Löe and Silness demonstrated the direct link between plaque buildup and gingival inflammation, further confirming that gingival health can be restored after resuming proper care. Microbial ecology shifts are central to gingivitis pathogenesis. In health, the oral microbiome is dominated by gram-positive Streptococcus species. With plaque accumulation, microbial communities transition to gram-negative periopathogens such as Porphyromonas, Tannerella, Treponema, and Prevotella. This dysbiosis provokes heightened inflammation, tissue damage, and, in susceptible individuals, progression to periodontitis. Individual variability in the inflammatory response has been associated with differences in the presence and activity of beneficial streptococci. Certain strains of Streptococcus salivarius produce lantibiotics called salivaricins-polycyclic antimicrobial peptides containing lanthionine residues. Salivaricins inhibit oral pathogens and have been investigated for their antimicrobial and probiotic properties, particularly in the context of rising antibiotic resistance. Probiotic S. salivarius strains isolated from healthy individuals have demonstrated safety and antimicrobial potential in previous studies, supporting their use in preventing oral and respiratory infections. A strain of S. salivarius designated SALI-10 produces a lantibiotic, Salivaricin 10, and is being evaluated as a candidate for gingivitis prevention. This strain is hypothesized to (1) help stabilize populations of beneficial streptococci during plaque accumulation, (2) competitively inhibit periopathogens such as Porphyromonas and Prevotella, and (3) suppress the dysbiotic shift toward gram-negative dominance. By contributing to microbial balance and reducing inflammatory triggers, SALI-10 may support resilient host-microbe interactions associated with gingival health. This approach may offer a dual antimicrobial and microbiome-stabilizing strategy with relevance to gingivitis management and longer-term periodontal health.

Variation in Gingival Inflammatory Responses

The aim of this NIH National Institute of Dental and Craniofacial Research (NIDCR) funded study is to identify molecular mechanisms underlying observed variations in human responses to natural accumulation and maturation of dental plaque.

A Study Investigating Gingival Crevicular Fluid Biomarkers Following Use of a Commercially Available Toothpaste Containing Stannous Fluoride

The aim of this study is to evaluate the feasibility, sensitivity, and interpretability of gingival crevicular fluid (GCF) cytokine biomarkers as early indicators of tissue recovery following use of commercial dentifrice compared with a standard fluoride dentifrice in experimental gingivitis model, after 14 days twice daily use.

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.

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.

Comparative Evaluation of Oxygen-enriched and Chlorohexidine Mouthwashes as an Adjunct to Non-surgical Periodontal Therapy and Its Efficacy on Gingival Inflammation, Plaque Scores and Patient-reported Outcomes

comparison between CHX and oxygen-enriched mouthwash

Effects of Nonsurgical Periodontal Treatment on GCF Calprotectin and IL-10 in Rheumatoid Arthritis

This study evaluates the relationship between rheumatoid arthritis and periodontal health and examines the effects of nonsurgical periodontal treatment on clinical periodontal findings and gingival crevicular fluid biomarkers. Participants with and without rheumatoid arthritis were classified according to periodontal status as periodontally healthy, gingivitis, or periodontitis. Clinical periodontal measurements and gingival crevicular fluid levels of calprotectin (MRP-8/14) and interleukin-10 (IL-10) were evaluated at baseline, 1 month, and 3 months. Disease Activity Score-28 (DAS28) was also evaluated in participants with rheumatoid arthritis.

Clinical Study Examining the Control of Plaque and Gingivitis

The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.

Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems

Qualified subjects will be enrolled and randomized to either one of the three 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 three months and six months of product use. All subjects will be followed for adverse events throughout the study.

Study to Investigate 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

Smartphone App Versus Verbal Motivation for Oral Hygiene in Fixed Orthodontic Patients

This study looked at whether a smartphone app can help patients with fixed braces keep their teeth cleaner than usual spoken advice alone. Fixed braces make plaque harder to remove, which can harm the teeth and gums, so good brushing habits matter. Fifty patients aged 14 to 22 were divided at random into two groups. One group used a purpose-made app ("iTeeth Orthodontics") that sent brushing reminders, timed brushing, and kept a brushing log. The other group received the usual spoken oral-hygiene motivation. Both groups used the same brushes, toothpaste, and rinse, and followed the same cleaning routine. Plaque was measured from photographs at 10 days and at 1, 2, and 3 months, using a computer to calculate how much of each tooth surface was covered by plaque. The two groups were then compared.

TBC1D15 / Rab7 / Fis1 Pathway in Periodontal Disease

This study will look at certain proteins in the fluid found around the gums (called gingival crevicular fluid, or GCF) of people with healthy gums, gingivitis (mild gum inflammation), or periodontitis (more severe gum disease). The proteins being studied, TBC1D15, Rab7, and Fis1, help control the health of mitochondria, which act like tiny "power plants" inside our cells. When mitochondria become damaged, the body normally breaks them down and recycles them through a process these proteins help control. It is not yet known how this process relates to gum disease. Seventy-two healthy adults will take part in this study and will be grouped based on the health of their gums. A sample of gum fluid (GCF) will be collected from each participant and tested to measure the levels of these proteins. Researchers want to find out whether the levels of these proteins change as gum disease becomes more severe. If levels differ between people with healthy gums and those with periodontitis, this may suggest that problems with mitochondrial health and cleanup play a role in how gum disease develops and gets worse. This information may help researchers better understand the biological processes involved in gum disease and could eventually lead to new ways to detect or treat it earlier.

Personalized 3D Visualization for Oral Hygiene and Motivation in Adults With Gingivitis

This study evaluated whether personalized three-dimensional images of possible future changes in the gums could improve oral hygiene and motivation in adults with gingivitis. Gingivitis is inflammation of the gums associated with dental plaque. Eighty-four adults aged 18-60 years were randomly assigned to three groups of 28 participants. The groups received conventional oral hygiene education, general three-dimensional educational animations, or personalized three-dimensional visualization using models created from their own intraoral scans. All participants received the same nonsurgical periodontal treatment and instruction in toothbrushing and cleaning between the teeth. The personalized images illustrated possible gum recession and tissue changes if periodontal care and daily plaque control were neglected. They were educational scenarios, not individual predictions of future disease. Personalized visualization was accompanied by a clinician-guided motivational discussion. Dental plaque, gum inflammation, gum bleeding, and motivation toward dental treatment were assessed before treatment and six weeks later. The study compared these outcomes among the three educational approaches.

ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE

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