Clinical Research Directory

The Role of Granulation Tissue in Periodontal Regeneration

The goal of this observational study is to distinguish the infectious, healing, and regeneration-related characteristics of two types of gingival granulation tissues, namely infra-osseous and supra-osseous granulation tissues, in people with severe periodontitis (gum disease). Researchers aim to denote if these tissues may play role in healing after periodontal treatment. Researchers will also compare smokers and non-smokers to see if smoking disrupts the healing potential or infectious properties of granulation tissue. Participants will provide gingival fluid (before) and granulation tissue samples (at the time of) periodontal surgery. The main questions this study aims to answer are: 1. Do infra- and supra-osseous granulation tissues have different healing potential and infectious properties? 2. How do these tissues differ in people who smoke compared to people who do not smoke?

Timing of Oral Hygiene Improvement Relative to Subgingival Instrumentation

This single-centre, randomized split-mouth trial assessed clinical periodontal changes and acute systemic inflammatory responses when supra- and subgingival instrumentation was performed concurrently with oral hygiene instruction or after 90 days of oral hygiene reinforcement. Ten adults with periodontitis participated. One upper and one lower quadrant were randomly allocated to immediate instrumentation, while remaining quadrants received oral hygiene instruction and were instrumented at day 90. Clinical outcomes were evaluated at baseline, day 90 and day 180. High-sensitivity C-reactive protein was sampled before and 24 hours after each instrumentation session.

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

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

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.

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

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

NON-SURGİCAL PERİODONTAL THERAPY WİTH L-ARGİNİNE

This study aims to investigate whether a single local application of L-arginine - a naturally occurring amino acid - into the gum pocket, in addition to standard treatment, can improve healing outcomes in patients with gum disease (periodontitis). The study is being conducted at the Faculty of Dentistry of Alanya Alaaddin Keykubat University and has received ethical approval from the Antalya Provincial Health Directorate Ethics Committee. Periodontitis is a chronic inflammatory disease in which the tissues and bone supporting the teeth are gradually damaged by bacteria. If left untreated, it can lead to tooth loss. The current standard treatment involves deep cleaning of the tooth root surfaces to reduce the bacterial load. This study tests whether adding an L-arginine solution to this treatment provides additional benefit, as laboratory and animal studies have shown that L-arginine has anti-inflammatory, antioxidant, and bone-regeneration-supporting effects. Sixty volunteers aged 18-65, diagnosed with Stage III periodontitis and who have not received any periodontal treatment in the past six months, will be enrolled. Participants will be randomly assigned to one of two groups: one group will receive L-arginine solution and the other will receive saline solution (placebo) applied into the gum pocket. Gum pocket depth, inflammatory markers, and bone levels will be assessed at baseline and at 3 months after treatment. The total follow-up period for each participant will be 3 months. Participation is entirely voluntary; participants have the right to withdraw from the study at any time. No serious risks are anticipated, and all personal information will be kept strictly confidential.

Antibiotic Resistance Genes in Periodontitis

Antimicrobial resistance (AMR) is a major global public health concern, and the oral microbiome may serve as an important reservoir of antibiotic resistance genes (ARGs). Periodontitis is a chronic inflammatory disease characterized by dysbiosis of the subgingival microbiome and progressive destruction of tooth-supporting tissues. The complex microbial communities within subgingival biofilms may facilitate the exchange of ARGs through horizontal gene transfer (HGT), potentially contributing to the dissemination of antimicrobial resistance. This observational study aims to comparatively investigate the microbial composition, antibiotic resistance gene profiles, and associated mobile genetic elements (MGEs) in the subgingival microbiomes of periodontally healthy individuals and patients with periodontitis using shotgun metagenomic sequencing. Subgingival plaque samples will be collected from 50 participants, including 25 periodontally healthy individuals and 25 patients diagnosed with periodontitis, attending Istanbul University Faculty of Dentistry. Following microbial DNA extraction, shotgun metagenomic sequencing will be performed to characterize the taxonomic and functional composition of the subgingival microbiome. Bioinformatic analyses will be conducted using established databases and tools, including CARD, RGI, ARGs-OAP, MobileElementFinder, PlasmidFinder, ICEberg, and ISfinder, to identify ARGs, characterize MGEs, and investigate their potential associations. The study will compare the diversity, abundance, and distribution of ARGs and MGEs between the two groups and assess the potential relationship between periodontal dysbiosis and the genetic capacity for horizontal transfer of antibiotic resistance. By providing a comprehensive characterization of the subgingival resistome and its associated mobile genetic elements, this study aims to improve understanding of the potential contribution of periodontal disease to antimicrobial resistance and provide scientific evidence supporting the rational use of antibiotics in periodontal care.

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.

Salivary Mitofusin-1 Levels in Periodontitis: Associations With Disease Severity, Smoking, and Treatment Response

Periodontitis (gum inflammation) is a common disease worldwide. This study aims to investigate a novel biomarker, a protein called Mitofusin-1 (Mfn1), in saliva that may be associated with the severity of periodontitis and response to treatment. The study will include periodontally healthy individuals, individuals with mild to severe periodontitis, and smokers with severe periodontitis. Participants will receive saliva samples and undergo clinical periodontal examinations. Individuals with periodontitis will receive standard periodontal treatment, and changes in Mfn1 levels will be assessed 3 months after treatment. The study is expected to shed light on the potential utility of Mfn1 as a marker in the diagnosis and follow-up of periodontitis.

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

Comparison of Autologous Tooth and Bovine Xenograft in Periodontal Healing After Mandibular Third Molar Extraction

This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars. Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.

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

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

Photodynamic Therapy as an Adjunct in Periodontal Treatment

This study aims to evaluate the clinical effectiveness of antimicrobial photodynamic therapy (aPDT) as an adjunct to scaling and root planing (SRP) in the treatment of periodontitis. A split-mouth design will be used, in which one hemiarch receives conventional SRP and the contralateral hemiarch receives SRP combined with aPDT. Clinical periodontal parameters, including probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), plaque index (PI), and gingival index (GI), will be assessed at baseline and 30 days after treatment. The study seeks to determine whether adjunctive aPDT improves periodontal outcomes compared with conventional non-surgical periodontal therapy alone.

Dental Loupe Versus Dental Operating Microscope for Non-Surgical Periodontal Treatment

Periodontitis is a multifactorial, non-infectious disease that can lead to tooth loss if left untreated. Advanced stages of periodontitis can affect chewing ability, nutritional status, and quality of life. Calculus removal, root planing, and mechanical removal of plaque should be considered a fundamental part of initial periodontal treatment. Furthermore, patients who undergo calculus removal and root planing followed by regular maintenance programs experience less tooth loss and clinical attachment loss. Calculus removal and root planing are integral parts of non-surgical periodontal treatment to remove bacterial plaque and calculus from diseased root surfaces. The use of magnification systems to increase the field of view in both surgical and non-surgical procedures dates back to the 1860s with the first use of surgical microscopes. Magnification systems were first used in dentistry in the first half of the 20th century. In 1978, Apotheker and Jako developed the first surgical microscope for use in dentistry. The use of magnifying loupes as visual aids by dentists has become increasingly popular over the years, with continuous improvements in design and effectiveness. A 2019 survey among dentists indicated that magnifying lenses are one of the significant technological advancements in this profession. Periodontal endoscopy is also one of the approaches clinicians use to improve visibility. Dental magnification systems are known to increase effectiveness, especially in interproximal areas where access and visibility are limited. Clinical studies have compared root surface planing procedures performed with periodontal endoscopy with traditional root surface planing. The results of the studies showed a significant difference in clinical outcomes in patients treated with periodontal endoscopy compared to those treated with traditional methods. The aim of this study is to analyze the clinical and microbiological benefits of image magnification systems (dental loupe and dental microscope) in scaling and root surface planing in the treatment of patients with periodontitis.

Serum Inflammatory Protein Concentration During Dental Treatment

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

Digital Quantification of Dental Plaque Based on Intraoral Scanner Images

This diagnostic validation study aims to develop and validate a digital method for dental biofilm quantification using three-dimensional images obtained by an intraoral scanner. Twenty participants will undergo intraoral scanning at three time points: before and after plaque disclosure, and after supervised toothbrushing. The digital method's accuracy will be compared with traditional clinical assessment methods (Turesky Plaque Index).

Laser Assisted Open Flap Debridement

The study involves the surgical treatment of patients with Stage I to III of periodontitis. Following completion of Steps 1 and 2 of periodontal therapy according to the EFP guidelines for the treatment of periodontitis, sites presenting with residual probing depths greater than 5 mm and non-contained periodontal defects will undergo open-flap debridement and decontamination. In one group, debridement and decontamination will be performed using manual and ultrasonic instrumentation, whereas in the other group, the same treatment will be supplemented with laser therapy.

Integrated Diabetes and Oral Health Care in Oman

Type 2 diabetes mellitus (T2DM) and periodontal (gum) disease are closely related conditions that may negatively affect each other. However, oral health is not routinely integrated into diabetes self-management education. This study will evaluate whether a structured diabetes-oral health educational intervention based on the Health Belief Model can improve glycaemic control, periodontal health, self-management behaviours, and quality of life among adults with T2DM in Oman. This multicentre randomized controlled trial will include 290 adults with T2DM. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive six individual, structured diabetes-oral health education sessions over 12 weeks in addition to usual care. The control group will continue to receive standard diabetes care and education. Participants will be followed for 12 months. The primary outcome is change in glycated haemoglobin (HbA1c) from baseline to 12 months. Secondary outcomes include periodontal health, diabetes and oral-health self-care behaviours, Health Belief Model constructs, quality of life, psychological well-being, diabetes distress, healthcare utilization, and healthcare costs. The study will also assess the cost-effectiveness of the intervention. Exploratory components will assess previously undiagnosed periodontal disease and examine associations between periodontal changes and the oral microbiome.

Oral Hygiene Assistance Training Program

This is an oral health study with a nursing home staff training program and product intervention.

Efficacy of Oral Hygiene Regimens in Patients Undergoing Non-Surgical Periodontal Treatment

The objective of this clinical study is to evaluate the efficacy of multi-component oral hygiene regimens as adjunctive to non-surgical periodontal treatment in patients with stage II periodontitis.

Evaluate the Efficacy of an Oral Health Behavioral Intervention in People With Diabetes

The purpose of this clinical study is to evaluate the effect of a behavioral intervention on the number of preventive and treatment dental claims in a population of people with Type 2 Diabetes.

Minimally Invasive Non-Surgical Periodontal Therapy Alone vs. Minimally Invasive Non-Surgical Periodontal Therapy With I-PRF With or Without Chlorhexidine on Stage III Periodontitis Patients

This study aims to assess the effect of chlorhexidine augmented I-PRF together with MINST and I-PRF alone with MINST versus MINST alone in the treatment of stage III periodontitis patients.

Periodontal Status and Thyroid Markers in Pregnancy

This cross-sectional study aims to evaluate the association between periodontal status and serum thyroid markers among 100 systemically healthy pregnant women aged 18-45 years in the second trimester (13-27 weeks). Pregnancy is characterized by profound hormonal and immunological changes that influence both periodontal health and thyroid function. While periodontal inflammation has been associated with thyroid dysfunction in the general population, no study has explored this relationship during pregnancy. Participants will be recruited from the Department of Gynaecology, PGIMS, Rohtak, and undergo comprehensive periodontal examination, including periodontal inflamed surface area (PISA), probing pocket depth (PPD), clinical attachment loss (CAL), bleeding on probing (BOP), and plaque index (PI). Blood samples will be collected to assess thyroid stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4), anti-thyroid peroxidase (Anti-TPO) antibodies, and high-sensitivity C-reactive protein (hsCRP). The primary objective is to determine the association between PISA and serum TSH levels, while secondary objectives include evaluating the relationship of periodontal parameters with T3, T4, Anti-TPO, hsCRP, and the distribution of thyroid profiles (euthyroid, hypothyroid, and hyperthyroid) according to periodontal status. Data will be analyzed using appropriate descriptive statistics, Pearson/Spearman correlation, and multiple linear regression after testing for normality. By investigating the interplay between periodontal inflammation and thyroid function during pregnancy, this study seeks to generate novel evidence that may support integrated periodontal and antenatal care strategies, ultimately contributing to improved maternal and fetal health outcomes.

Effect of GLP-1 Receptor Agonists on Periodontal Health and Response to Nonsurgical Periodontal Therapy

This study aims to evaluate the effects of glucagon-like peptide-1 receptor agonist (GLP-1 RA) use on periodontal health and the response to non-surgical periodontal therapy in individuals with obesity and periodontitis. Participants with obesity and periodontitis will be divided into two groups: those who have been using a GLP-1 RA for at least 3 months and those who are not using any medication for obesity. All participants will receive the same non-surgical periodontal treatment, including oral hygiene instruction, scaling, and root planing. Periodontal clinical measurements and gingival crevicular fluid samples will be collected before treatment and at 3 and 6 months after treatment. The study will compare changes in periodontal health and inflammatory markers between the two groups to determine whether GLP-1 RA use is associated with periodontal health and the response to non-surgical periodontal therapy.