Clinical Research Directory

Performance of the Treatment of Periodontitis According to the Bioperio® Protocol

This multicenter, prospective, single-arm observational study evaluated the 3-month clinical performance of the Bioperio® protocol, a standardized, patient-centered framework for managing periodontitis. The protocol combined professional supra-gingival scaling, oral hygiene instruction and motivation, full-mouth subgingival instrumentation, and-in Stage III/IV cases-adjunctive enamel matrix derivative application in deep pockets.

Association Between Periodontitis and Chronic Kidney Disease

The goal of this observational study is to explore the comorbid association between periodontitis and chronic kidney disease (CKD) based on the oral-renal axis in adults aged 18 to 75 years. The main question it aims to answer is: Is periodontitis associated with chronic kidney disease through oral-renal axis-related mechanisms? Participants aged 18 to 75 years will be recruited and undergo clinical assessment, sample collection, and laboratory testing as part of the study. Periodontal status, kidney function, and oral microbiota characteristics will be evaluated to investigate the association between periodontitis and CKD. Fecal samples will also be collected for exploratory analysis of gut microbiota to assess its potential relevance to the oral-renal relationship.

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.

A Non-inferiority Study of Laser Combined With Ultrasonic Debridement Therapy (LCUDT) Versus Manual Combined With Ultrasonic Debridement Therapy (MCUDT) in the Treatment of Periodontitis

The rate of periodontal health among adults and the elderly in China is less than 10%, with the prevalence of severe periodontitis reaching 30.6% in those aged 35 and above. While conventional periodontal treatment (ultrasonic combined with manual subgingival scaling) is effective, it has significant drawbacks: it is technically demanding, time-consuming, and often causes patients considerable pain and discomfort. This can lead to poor treatment compliance, postoperative tissue damage, bleeding, and root sensitivity.Lasers, such as the Nd:YAG laser, offer advantages like antibacterial effects and minimally invasive debridement. Combining ultrasonic with laser therapy may improve patient comfort, but there is currently insufficient evidence to prove that its clinical efficacy is non-inferior to traditional manual scaling.This study aims to compare the clinical efficacy, patient acceptance, and postoperative recovery between "ultrasonic combined with laser debridement" and "ultrasonic combined with manual mechanical debridement."

Hyaluronic Acid and Albumin-PRF in Non-Surgical Periodontal Therapy

Periodontitis is a chronic inflammatory disease that leads to the destruction of the supporting tissues of the teeth. Non-surgical periodontal treatment is the first-line approach for the management of periodontitis; however, the use of adjunctive therapeutic agents may improve clinical outcomes. The aim of this randomized clinical trial is to evaluate the effects of hyaluronic acid gel and albumin platelet-rich fibrin (Alb-PRF) used as adjuncts to non-surgical periodontal treatment on clinical and biochemical parameters in patients with Stage III periodontitis. Participants will be randomly allocated into three groups: an Alb-PRF group, a hyaluronic acid gel group, and a control group receiving non-surgical periodontal treatment alone. Clinical periodontal parameters and biochemical markers obtained from gingival crevicular fluid will be assessed at baseline and at 1 and 3 months after treatment. The findings of this study are expected to contribute to the evaluation of the potential benefits of adjunctive biological and anti-inflammatory applications in the non-surgical periodontal treatment of patients with Stage III periodontitis.v

Oral-Periodontal Evaluation and Assessment of Oral Fluid Biomarkers in Patients With Hepatitis B+D

Periodontal disease is a chronic inflammatory condition associated with systemic diseases, highlighting the concept of periodontal medicine. This study aims to investigate the relationship between periodontal inflammation, oral lesions, and hepatitis B+D infection, with or without bulevirtide treatment. Oral-periodontal clinical parameters and targeted inflammatory biomarkers in saliva and gingival crevicular fluid will be evaluated in three groups: patients with hepatitis B+D receiving bulevirtide, patients with hepatitis B+D not receiving bulevirtide, and healthy controls.

Effect of Nicotine Gingival Fibroblast Intoxication on the Response of Periodontal Treatment

Impact of nicotine gingival intoxication on the clinical outcomes after periodontitis non surgical treatment

Tinder Fungus as an Adjunct to Non-surgical Periodontal Therapy for Periodontitis

The goal of this interventional clinical study is to learn if a Tinder fungus-based formulation -specifically a toothpaste and oral supplement powder-works as adjuncts to non-surgical periodontal therapy (NSPT) in patients with periodontitis. The main questions it aims to answer is: • Does the Tinder fungus-based formulation as an adjunct to NSPT reduce bleeding on probing more than a commercially available toothpaste as an adjunct to NSPT? Researchers will compare tinder fungus toothpaste and oral powder as an adjunct to NSPT to a commercially available toothpaste as an adjunct to NSPT to see if the Tinder fungus-based formulation works as adjuncts to NSPT in patients with periodontitis. Participants will: * Take tinder fungus toothpaste and oral powder or a commercially available toothpaste as an adjunct to NSPT twice daily for 30 consecutive days * Visit the clinic at least twice including a visit before and after the intervention * Keep a diary documenting their well-being and the number of times they used the toothpastes in the morning and evening.

Non-Surgical Treatment of Periodontitis With Adjunctive Sodium Hypochlorite/Amino Acids and Cross-Linked Hyaluronic Acid

The goal of this clinical trial is to learn if using sodium hypochlorite/amino acid gel, with or without cross-linked hyaluronic acid, as an addition to standard non-surgical periodontal therapy works to treat periodontitis in adults. It will also learn about the safety of these treatments. The main questions it aims to answer are: Does the adjunctive treatment reduce bleeding on probing, plaque index, and periodontal pocket depth? What medical or dental problems do participants have when receiving these treatments? Researchers will compare: Standard non-surgical periodontal therapy alone Standard therapy plus sodium hypochlorite/amino acid gel Standard therapy plus sodium hypochlorite/amino acid gel and cross-linked hyaluronic acid ("Clean and Seal" protocol) Participants will: Receive their assigned treatment during one clinical session per the study protocol Have clinical measurements taken before treatment and at three months after treatment Be monitored for any dental or medical adverse events related to the procedures

Biologicals in Management of Intra-Bony Defects

The aim is of this study is to evaluate and compare the effects (clinical and radiological) of different biomaterials on the repair of bone defects around the teeth. When participating in this study, persons will be scheduled for local surgical intervention of the gums. Under local anaesthesia, the gums will be opened minimally to gain insight into the underlying bone defect. After the bone defect has been made completely free of inflammation, they will be randomly assigned to one of the groups below and the biomaterials for this group will be used to fill the defect around your teeth. The different biomaterials are artificial bone + amelogenin; artificial bone + hyaluronic acid; artificial bone + blood preparation (L-PRF) or blood preparation alone. Then the gums will be closed again with a suture and they will receive the necessary instructions regarding the procedure.

Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus

The goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. The main question it aims to answer is: aPDT treatment is more effective in treating halitosis? aPDT treatment is more effective in periodontitis? Researchers will compare aPDT treatment to conventional treatment (scaling and root planning and tongue scraper) to see if aPDT has additional effects in reducing halitosis and improving periodontal health. * Participants will be asked to visit the clinic once a week for exam and treatment during 1 month. * After active treatment they will be asked to come to maintenance and control visits once a month until 6 months.

Periodontal Dressings in Non-Surgical Therapy

This study aims to evaluate and compare the efficacy of two different eugenol-free periodontal dressing materials-Ora-Aid (a hydrophilic polymer) and Coe-Pak (a zinc oxide-based paste)-following non-surgical periodontal treatment (scaling and root planing, SRP) in patients with Stage 3, Grade A periodontitis. The study utilizes a split-mouth design to analyze clinical periodontal parameters, patient comfort, and microbiological changes over a 3-month period.

Minimally-Invasive Non-Surgical Therapy of Peri-Implantitis

This multicenter, single-masked randomized controlled clinical trial evaluates the effectiveness of minimally-invasive non-surgical therapy (MINST) compared with standard non-surgical peri-implant therapy (NSPT) in patients diagnosed with peri-implantitis. The study investigates clinical outcomes, radiographic bone levels, patient-reported outcomes, and treatment time over 12 months.

Development, Validation, and Assessment of the Diagnostic Accuracy of a Questionnaire for Periodontitis Screening

The present study aims at validating the Italian version of one of the most widely used epidemiological questionnaires for periodontitis screening: the CDC/AAP questionnaire \[hereafter referred to as the CDC/AAP\_ITA questionnaire\]. The study also aims to develop a modified version of the CDC/AAP questionnaire, enriched with additional questions, and to evaluate its diagnostic accuracy \[hereafter referred to as the QSIdP questionnaire\]. The study will be conducted at the Unità Complessa di Odontoiatria, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara (Director: Prof. Leonardo Trombelli), in collaboration with nine (9) other Italian clinical centers.

Metabolic Syndrome Associated Diet

The goal of this observational study is to examine the relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate the role of the Dietary Inflammatory Index (DII) in this association. The main question it aims to answer is: Does a pro-inflammatory diet, as measured by the DII, increase the risk or severity of periodontitis in individuals with metabolic syndrome? Participants will include adults who meet the diagnostic criteria for metabolic syndrome. Their periodontal health will be assessed through standard clinical parameters, and dietary data will be collected using a validated food frequency questionnaire to calculate individual DII scores. The study will observe and analyze these factors to explore potential links between diet-induced inflammation, systemic metabolic health, and periodontal outcomes.

"Effect of Ibuprofen on Acute Inflammatory Response After One-Stage Periodontal Therapy"

The goal of this ( Clinical Trial ) is to evaluate the efficacy of Ibuprofen in reducing acute inflammatory response (hs-CRP, ProCT, IL-6) after one hour and one week following one stage non surgical periodontal therapy. The main question it aims to answer is: "Does Ibuprofen effectively reduce the acute inflammatory response ( hs-CRP, ProCT, IL-6) following one-stage non-surgical periodontal therapy?"

Vector® System vs Mini-Five Curettes in Non-Surgical Periodontal Therapy

This randomized clinical trial aims to compare the clinical and radiographic outcomes of the Vector®️ ultrasonic system and mini-five curettes in non-surgical periodontal therapy. Patients diagnosed with periodontitis will be randomly assigned to either ultrasonic instrumentation or manual instrumentation. Clinical periodontal parameters and radiographic bone level changes will be evaluated at baseline, 1, 3, 6, and 12 months. The primary objective is to assess differences in clinical attachment level and probing depth reduction between the two treatment modalities.

Prevalence of Treponema Parvum in Subgingival Microbiome of Patients With Periodontitis

The current study primarily aims to evaluate the presence of T. parvum in periodontal health and disease, and its correlation with clinical parameters. Subgingival plaque samples will be collected using sterile paper points then the samples will be analyzed using quantitative polymerase chain reaction (qPCR) to detect T. parvum and estimate its relative amount in the biofilm. The results may help clarify the association between T. parvum and periodontitis.

Impact of Guided Biofilm Therapy on Epithelial and Mesenchymal Biomarkers in Periodontitis Patients

The goal of this clinical trial is to investigate the clinical and biochemical effects of the guided biofilm therapy protocol as an alternative to the conventional non-surgical periodontal therapy in patients with periodontitis. The main question it aims to answer is: Does the guided biofilm therapy (GBT) protocol have an impact on gingival crevicular fluid (GCF) epithelial and mesenchymal biomarkers in patients with periodontitis? All patients will be instructed to brush their teeth twice daily and will be supplied with the same type of toothpaste and toothbrush, with suitable interdental aids. All patients will be instructed to attend again after 7 days. At baseline, full-mouth periodontal charting and radiographs will be obtained and after 1-hour, GCF samples will be collected from both test and control groups. Sites allocated to control group will undergo supragingival debridement by using ultrasonic device. After one week, the control group will receive RSD using area specific (Gracey) curettes (Medesy, Italy) according to the 24-hours protocol and will receive teeth polishing by using rubber polishing cups and tooth polishing paste, while the test group will receive a full GBT protocol which includes eight steps: (1) ASSESS, (2) DISCLOSE, (3) MOTIVATE, (4) AIRFLOW, (5) PERIOFLOW, (6) PIEZON PS\*, (7) CHECK, and (8) RECALL. After finishing the treatment session, the patients will be asked to attend for follow up, clinical evaluation of PI, BOP, PPD, and CAL, and GCF samples collection after 1 month and 3 months.

Chronic Kidney Disease Associated Diet

The goal of this observational study is to investigate the relationship between chronic kidney disease (CKD) and periodontitis, and to evaluate the potential mediating role of dietary inflammatory potential, measured by the Dietary Inflammatory Index (DII), in this association. The main question it aims to answer is: Does a pro-inflammatory diet, as reflected by a higher DII score, exacerbate periodontal inflammation in individuals with chronic kidney disease? Participants will include adults diagnosed with CKD at various stages. Periodontal status will be assessed through clinical parameters such as probing depth, clinical attachment loss, and bleeding on probing. Dietary intake will be evaluated using a validated food frequency questionnaire, and DII scores will be calculated accordingly. The study will aim to observe and analyze whether dietary inflammation contributes to increased periodontal disease severity in CKD patients, potentially offering insight into modifiable risk factors relevant to both systemic and oral health.

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.

Evaluation Of The Efficacy Of Subgingival Application Of Lovastatin Gel As An Adjunct To Non-Surgical Treatment Of Periodontitis In Generally Healthy Smokers And Non-Smokers Patients in Central Europe.

The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing). The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant: * a gel containing the medication will be applied under the gum of one tooth * a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth. Before applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working. The study will last six months. Expected results: * all participants will experience an improvement in the condition of their gums after treatment * the effect of treatment will be better in non-smokers than in smokers * the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.

Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes

This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule. Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2. The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction. This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.

Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects

The present study pretends to show the results of combining a modification of the Non-incised papillae surgical approach (NIPSA) attempting to improve the outcome in the treatment of teeth with advanced periodontal support loss.