Clinical Research Directory

This a Clinical Trial to Evaluate the Efficacy of I-PRF, Povidone-Iodine and Laser as Adjuncts to Non-surgical Periodontal Treatment in Smokers and Non-Smokers Periodontitis Patients

This study is a randomized, controlled, split-mouth clinical trial designed to evaluate and compare the effectiveness of four different subgingival adjuncts used along side standard Scaling and Root Planning (SRP). This protocol is designed to be a standardized therapeutic model. The subgingival adjuncts are standardized, ensuring that the results are not operator dependent and can be replicated across any dental unit. The primary goal of this study is to evaluate the clinical efficacy of three distinct adjunctive strategies: Biological (I-PRF), Antiseptic : Povidone- iodine , Diode-Laser activation, compared to a Saline Control in the initial treatment of stage 2, 3 and stage 4 of the 2018 AAP/EFP periodontal classification.

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.

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.

Short Implants in Unitary Implant-supported Rehabilitations in the Posterior Maxilla and Mandible: 5 Years of Follow-up

Implant-supported rehabilitation of regions with severe bone resorption is a challenge for implant dentists. Structures such as the maxillary sinus and the inferior alveolar canal often make it impossible to use implants of lengths considered standard in the literature. The use of short 7 and 8 mm implants with new macrogeometries and surface treatments, in addition to the application of Morse taper prosthetic connections, has shown results that increasingly encourage their use. However, the longevity of these rehabilitations needs to be constantly evaluated. In this work, unitary implant-supported rehabilitations in the posterior jaws, supported by short (7 and 8 mm) tapered Morse connection implants, will be followed for a period of 5 years. A total of 100 subjects rehabilitated with tapered Morse connection implants, with diameters between 3.5 and 4.5 mm, will be evaluated. Peri-implant bone remodeling, implant stability measured through ISQ and clinical parameters will be evaluated per implant and over the evaluation time. Periapical radiographs will be obtained and digitized, analyzed by software and compared with the initial data. The data obtained will be analyzed, allowing longitudinal evaluations and the success rate of implant restorations supported by short implants.

Omega-3 Plus Low-Dose Aspirin in Smokers With Stage III Periodontitis

This randomized double-blind placebo-controlled clinical trial aims to evaluate the clinical and biochemical effects of omega-3 fatty acids combined with low-dose aspirin as an adjunct to scaling and root planing (SRP) in smoker patients with Stage III periodontitis. The study compares test and control groups regarding periodontal clinical parameters and gingival crevicular fluid interleukin-1 beta (IL-1β) levels Or other inflammatory markers that will be determined later at baseline, 3 months, and 6 months following treatment

Longitudinal Evaluation of Several Modalities of Treatment of Peri-implantitis: 5 to 23 Years Follow-up

To evaluate the peri-implant conditions of patients undergoing different surgical and non-surgical techniques, associated or not with regenerative therapies after long periods of time (between 5 and 23 years) 3\. MATERIAL AND METHODS 3.1. Experimental design This retrospective study will evaluate the peri-implant conditions of patients with peri-implantitis treated at the UnG Clinic using various types of treatments. To this end, participants will be selected from the UnG graduate clinic who received some type of treatment (surgical or non-surgical) until 2021. Participants selected for the study must sign the Informed Consent Form (ICF) after verbal and written explanation of the project. Subjects will receive oral hygiene instruction and professional prophylaxis prior to clinical examinations. 3.2. Sample selection This clinical study will be submitted for approval by the Ethics Committee of the University of Guarulhos (CEP-UnG). Subjects (minimum of 50 and maximum of 300) will be recruited and evaluated at the Implantology clinic of Guarulhos University. This sample was obtained based on the power test so that the study presented a power of around 80%, and NCI and bone loss were considered primary variables. 3.3. Inclusion criteria The sample included 300 systemically healthy individuals, over 18 years of age, who received some type of treatment (surgical or non-surgical) for peri-implantitis, associated or not with systemic antibiotic therapy. 3.4. Sample exclusion criteria Individuals who have lost the implants after some peri-implant therapy;' have undergone periodontal treatment for at least 6 months prior to the start of the study. Clinical examinations A single, trained and calibrated examiner will perform all clinical examinations. The examiner will be trained and calibrated before and during the study in order to achieve maximum reproducibility in measurements. The methodology to be used for intra-examiner calibration will be the one recommended by Araujo et al. 2003, in which the standard error of measurement for continuous periodontal clinical parameters is evaluated. For the other clinical variables, the mean level of agreement between the examiners will be determined and considered satisfactory when the value is greater than 90% (Kappa test). Clinical measures The following parameters will be recorded at six sites per implant using a periodontal probe North Carolina: 1. Plate index: 0 = absence of plaque; 1 = separate patches of plaque at the cervical margin; 2 = a thin, continuous band of plaque \[up to 1 mm\] at the cervical margin of the tooth; 3 = strip of plaque greater than 1 mm, but covering less than 1/3 of the tooth crown; 4 = plaque that covers at least 1/3 but less than 2/3 of the tooth's crown; 5 = plate covering 2/3 or more of the tooth's crown). 2. Gingival index : 0 = absence of inflammation; 1 = mild inflammation change in color and little change in texture; 2 = moderate inflammation - tempered glasses, redness, edema and hypertrophy; 3 = severe inflammation - marked redness and hyperplasia. 3. Bleeding on probing: 0 = absence; 1 = presence. 4. Suppuration: 0 = absence; 1 = presence. 5. Probing depth: distance (mm) from the peri-implant mucosal margin to the most apical portion of the peri-implant pocket. 6. Relative attachment level: distance (mm) from the implant shoulder to the most apical portion of the peri-implant pocket. 7. Keratinized tissue height : vertical distance (mm) measured from the mucogingival line to the peri-implant margin in the center of the buccal face of the implant. 8. Keratinized tissue thickness 1: measured in the center of the buccal surface of the ridge, at the midpoint between the mucogingival line and the top of the ridge. 9. Mesial and distal keratinized tissue thickness 2: measured over the ridge (mesial and distal of the implant) when the crown can be removed. 10. Evaluation of the biotype of peri-implant tissue: thin or thick, according to the visualization of the periodontal probe through the peri-implant tissue. Screw-retained implant crowns will be removed to observe clinical records, while cemented crowns will not be removed. Radiographic measurements As a way of evaluating the stability of bone tissue, the interproximal level of the bone crest will be measured by means of periapical radiographs. After the radiographic takes, the radiographs will be scanned and the distance in millimeters from the interproximal bone crest to the base of the implant will be evaluated.

Effects of Adjunctive Synbiotic Supplementation to Non-Surgical Periodontal Therapy in Smokers With Periodontitis

The aim of this study is to evaluate the effects of adjunctive synbiotic supplementation combined with non-surgical periodontal therapy in smokers with periodontitis. The main questions this study aims to answer are: Does adjunctive synbiotic supplementation improve clinical periodontal parameters in smokers with periodontitis? Does adjunctive synbiotic supplementation affect immunological and microbiological parameters associated with periodontal disease? Systemically healthy smokers and non-smokers diagnosed with generalized Stage III-IV Grade B/C periodontitis will be included in the study. Participants will first be divided into two main groups according to smoking status (smokers and non-smokers). These groups will then be further divided into two subgroups according to the use of synbiotic or placebo capsules. Therefore, the study will consist of four groups in total. The sample size of the study was determined as 92 participants, with 23 participants included in each group. All participants will receive non-surgical periodontal therapy (NSPT) at baseline. In addition to NSPT, participants will use either synbiotic or placebo capsules once daily for 90 days. To evaluate clinical periodontal, immunological, and microbiological parameters, periodontal measurements will be performed, and saliva and subgingival plaque samples will be collected. In addition, stool samples will be collected from participants to evaluate the effects of synbiotic supplementation on the gastrointestinal microbiota, and microbiota analyses will be performed. All samples will be collected again and evaluated at the third month following non-surgical periodontal therapy.

Comparison of the Efficacy of Conventional Versus Minimally Invasive Non-Surgical Periodontal Therapy in Periodontitis Patients

the aim of this study is to investigate the clinical outcomes of Minimally Invasive Non-Surgical Therapy(MINST) compared to Conventional non-surgical periodontal therapy (CNST)

Periodontal Disease in Rare Renal Disorders (PERIO-RA-RE)

This study aims to evaluate the burden and phenotypic spectrum of periodontal disease in patients with rare kidney disorders (such as Alport syndrome, Fabry disease, and tuberous sclerosis complex) and systemic lupus erythematosus (SLE), compared with chronic kidney disease (CKD) controls and population controls. This is a cross-sectional, case-control observational study. Participants will undergo a single structured evaluation including a full-mouth periodontal examination, a clinical questionnaire, and collection of relevant clinical and nephrological data. The primary objective is to compare the prevalence of periodontitis across study groups. Secondary objectives include characterization of periodontal disease severity, prevalence of gingivitis and xerostomia, and identification of disease-specific oral phenotypes. Exploratory analyses will assess associations between periodontal disease and clinical variables such as kidney function, proteinuria, and immunosuppressive exposure.

Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care

The aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.

Assessment of Spirulina Gel Prepared By Different Extraction Methods as an Adjunctive Therapy to Mechanical Debridement in the Treatment of Stage II Grade B Periodontitis

I) Patients: the present study will be carried on periodontitis patients. The patients will be informed about the treatment steps. This includes the possible effects or risks, and other treatment options according to the rules of the ethical committee of Faculty of dentistry, Mansoura University. Groups: Group I (negative control): 15 periodontally healthy subjects . Group II (positive control): 15 patients will be treated with mechanical debridement only. Group III (study group A): 15 patients will be treated with mechanical debridement followed by delivery of spirulina gel extracted by phosphate buffered saline (PBS). Group IV (study group B): 15 patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by 1.5% calcium chloride (CaCl2) aqueous solution. Group V (study group C): 15 patients will be treated with mechanical debridement followed by delivery of spirulina gel exracted by ethanol. In group III, IV and V extract of spirulina algae powder (Emtenan Health Shop,2019 © Egypt,TEL 16246) Periodontal evaluation will be performed for all patients at baseline and after three months including the following parameters: * Plaque index (PI). * Gingival index. * Probing pocket depth (PPD). * Clinical attachment level (CAL). Gingival crevicular fluid sampling. Local drug delivery Adequate amount of prepared ozonated sunflower and sunflower oil gel will be delivered into the selected periodontal pockets. Immunological analysis of TNF-α in GCF

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.

Artificial Intelligence for Diagnosing Periodontitis and Monitoring Gingival Inflammation

Background and Objective: Periodontitis and gingivitis are highly prevalent oral diseases that require accurate diagnostic classification and continuous gingival health monitoring. This study aims to develop, internally validate, and externally evaluate the diagnostic accuracy of artificial intelligence (AI) models for periodontitis staging and gingival inflammation assessment at both tooth and patient levels. Study Design: This is a multi-center observational study utilizing a large-scale primary clinical dataset for model development. To rigorously evaluate the generalizability of the trained AI models, two distinct pathways of independent external validation will be implemented across multiple clinical sites. Research Phases \& Validation Architecture: Phase 1 (Periodontitis Diagnosis via Probing): Development of an AI model to diagnose periodontitis (binary classification: stage 0/I vs. stage II/III/IV) at both tooth and patient levels, using comprehensive clinical periodontal probing as the gold standard. External Validation I will be performed using an independent cohort from another campus of the primary hospital to test the model's diagnostic accuracy. Phase 2 (Periodontitis Diagnosis via Radiographs): Development of an AI model to diagnose periodontitis (binary classification: stage 0/I vs. stage II/III/IV) at both tooth and patient levels, using digital panoramic radiographs as the reference standard. External Validation II will be conducted using distinct, independent image datasets acquired from two separate regional hospitals to evaluate geographic generalizability. Phase 3 (Gingival Inflammation Monitoring): Development of an AI model to monitor and assess gingival inflammation at both tooth and patient levels, based on Probing Depth (PD) and Bleeding on Probing (BOP) as the gold standard. This model's performance will also be evaluated through External Validation I using the independent dataset from the primary hospital's alternative campus. Significance: By validating the AI models across varied institutional workflows and imaging systems, this study will provide high-level evidence on the clinical utility and robustness of AI-driven digital systems for automated periodontal screening and long-term health monitoring.

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.

Oral Health and Systemic Diseases: Survey of General Practitioners

This cross-sectional observational study aims to assess the level of knowledge, clinical practices, and professional attitudes of General Practitioners (GPs) regarding oral health and its relationship with major systemic diseases, with particular emphasis on periodontal disease. Data will be collected through an anonymous, self-administered digital questionnaire distributed nationwide to General Practitioners practicing in Italy. The questionnaire will investigate participants' knowledge of oral diseases, awareness of oral-systemic associations, early identification of oral manifestations, educational background, and interdisciplinary collaboration with dental professionals.

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.

A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients

The goal of this clinical trial is to learn if a novel peptide-rich hydrogel works to achieve periodontal regeneration in adults. It will also learn about the safety of the hydrogel. The main questions it aims to answer are: * Does the novel peptide hydrogel achieve periodontal regeneration to a similar degree as another currently used therapy (hyaluronic acid)? * What medical problems, if any, do participants have when receiving the novel hydrogel treatment? Researchers will compare the novel peptide hydrogel to another commonly used hydrogel (hyaluronic acid) to see if the peptide hydrogel works to treat periodontal bone defects. Participants will: * Receive the novel hydorgel or hyaluronic acid when they undergo periodontal regenerative surgery * Visit the clinic at regular intervals for 1 year after the surgery for follow ups

Comparison Between Different Interdental Brushes in Adults With Periodontal Disease.

The aim of this exploratory study is to evaluate the efficacy of the tested interdental brush versus comparative interdental brushes in adults with periodontal disease, over a 4-week period.

Candida Albicans in Syrian Patients With Periodontitis

Periodontitis is a significant oral health issue characterized by inflammation and destruction of the supporting structures of the teeth. Recent research has indicated that Candida albicans, a common fungal pathogen, may play a role in the exacerbation of periodontal diseases. This study aims to investigate the prevalence and impact of Candida albicans in Syrian patients diagnosed with periodontitis, contributing to a better understanding of its role in oral health within this population.

Efficacy of Laser Therapy for Periodontitis

The aim of this study is to evaluate the efficacy of diode laser in addition to periodontal treatment in periodontitis patients and to investigate their effects on gingival crevicular fluid (GCF) cytokine levels before and after treatment, among some Yemeni individuals in Sana'a city.

Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Transcrestal Sinus Floor Elevation With Graftless Immediate Implant Placement in Subsinus Bone Height of 4-6 mm: A Pilot Study.

This present study will evaluate Schneiderian membrane perforation rates using osseodensification in TSFE with simultaneous graftless implant placement, under sinuscopic control monitored by an ENT specialist. An endoscopic evaluation will be continuously conducted throughout the surgical procedure. TSFE will be performed using Densah burs without the addition of bone graft material, followed by implant placement. The rationale behind this approach is to monitor the response of the Schneiderian membrane and assess the effects of Densah burs on membrane distention and the occurrence of SMP.

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.

ABX Versus CHX in NSPT

The study aims to compare the efficacy of a novel mouthwash based on microRepair ABX and an antibacterial complex with that of 0.12% chlorhexidine, both used as adjuncts to scaling and root planing.

Efficacy of Chlorhexidine and Morus Nigra Mouthwashes After Periodontal Treatment

This study aims to evaluate and compare the clinical, biochemical, and microbiological effects of chlorhexidine and Morus nigra (blackberry) mouthwashes used as an adjunct to non-surgical periodontal treatment (scaling and root planing - SRP) in patients with periodontal diseases. The participants will be divided into three groups: a control group receiving only SRP, a group receiving SRP combined with chlorhexidine mouthwash, and a group receiving SRP combined with Morus nigra mouthwash. Clinical periodontal parameters, gingival crevicular fluid levels of inflammatory markers (including TNF-a, IL-1b, and IL-10), and subgingival plaque microbiological profiles (such as red complex bacteria and Fusobacterium) will be evaluated at baseline, 1 month, and 3 months after the treatment.