Clinical Research Directory

Efficacy of Oral Prednisolone on Pain Reduction in Emergency Care of Acute Irreversible Pulpitis

Irreversible pulpitis is an inflammatory condition of the dental pulp, highly painful, representing one of the main reasons for consulting dental emergency. The recommended emergency care is a partial endodontic treatment under local and/or locoregional anesthesia. The purpose of the emergency partial endodontic treatment is to stop the pain of pulpitis by removing a portion of the pulp. The final endodontic treatment is ideally performed 72 hours after. The literature reports major difficulty in obtaining adequate anesthesia in the mandible to perform partial endodontic treatment, especially for the mandibular molars. This results in a very painful care for the patient. The management of this type of emergency is costly in terms of equipment and time for health facilities. Patient comfort, cost saving and rationalization of the care time justify the search for an alternative to emergency partial endodontic treatment. In current practice, the short course oral corticotherapy is used in the management of oral pain from inflammatory origin. Glucocorticoids, thanks to their anti-inflammatory action, can neutralize the inflammatory mediators and thus pain. The pulp inflammation can be treated with this molecule: the effectiveness of intraosseous local steroid injection for irreversible pulpitis of mandibular molars has already been shown but results in local comorbidities and requires specific device. Oral administration of short-course prednisolone is simple and safe but its effectiveness to manage pain caused by irreversible pulpitis has not yet been demonstrated. Per-os administration of prednisolone has a very high (90%) and rapid (≤ 4 hours) bioavailability. No difference in effectiveness between intravenous and oral administration of this molecule was reported. This oral treatment could limit comorbidities and technical difficulties related to intraosseous injection and could delay the endodontic treatment to 72 hours in optimal conditions of anesthesia for the patient. Despite the difficulties described for the partial endodontic treatment, it is very effective in pain reduction and can reach 100% of success. Therefore a non-inferiority design was chosen to compare the effect of a short-course oral corticotherapy to a partial endodontic treatment for the reduction of pain at the emergency care of the irreversible pulpitis in mandibular molars. The intervention arm will receive an oral dose of prednisolone (1 mg/kg) during the emergency visit followed-up by one morning dose by day during three days and the reference arm will have partial endodontic treatment. Both groups will have planned complete endodontic treatment 72 hours after enrolment.

Metagenomic Analysis and Postoperative Pain in Infected Root Canals Using Different Irrigation Protocols

Achieving effective root canal disinfection while minimizing postoperative pain is a critical goal in endodontic therapy. Advanced irrigation protocols, such as ultrasonic activation, laser activation, negative pressure irrigation (PulpSucker device), and mechanical activation (Easy Clean device), have shown promise in enhancing bacterial reduction within the root canal system. However, their impact on postoperative pain has not been fully explored. This randomized controlled clinical trial aims to compare bacterial reduction and postoperative pain levels in infected root canals using four different irrigation protocols. The study will use metagenomic analysis to evaluate changes in bacterial community composition and the Visual Analogue Scale (VAS) to assess patient-reported pain levels at multiple time points postoperatively.

Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries

The purpose of the Research Study and Overview of Participation: This study will compare different approaches used to prevent pain when giving local anesthesia to numb the teeth while managing dental cavities and decay. Specifically, it seeks to determine which approach will reduce the pain and discomfort during or after the procedure. This will help dentists to choose the best approach to reduce patient's pain and discomfort and improve the overall experience of dental treatment. Participants in the study would likely undergo the following: 1. Screening and Consent: Participants would be assessed for eligibility (e.g., age, health status, and presence of dental caries requiring treatment) and would provide informed consent. 2. Intervention: Participants would be randomly assigned to different groups based on the type or method of topical anesthesia being tested. 3. Treatment Procedure: Dental caries management would be performed under local anesthesia, with the designated topical anesthetic applied beforehand. 4. Pain Assessment: Participants would rate their pain levels during and after the procedure using validated pain measurement scales (e.g., visual analog scale). 5. Follow-Up: Participants might be monitored for a short duration post-treatment to assess any residual pain or side effects. This design ensures that the study collects reliable data on the effectiveness of the different topical anesthetic approaches while prioritizing patient safety and comfort.

Predicting Vital Pulp Treatment Outcomes in Symptomatic Pulpits Using Metabolic Biomarker

This prospective controlled clinical trial investigates whether metabolic biomarkers measured in pulpal blood at the time of carious pulp exposure can predict the 12-month outcomes of vital pulp treatment in symptomatic permanent teeth. Eligible patients aged 16-50 years presenting with deep carious pulp exposure will undergo vital pulp therapy (partial pulpotomy or full pulpotomy). Pulpal blood samples will be collected at the time of exposure and analyzed using High-Performance Liquid Chromatography (HPLC). Treatment outcomes will be assessed clinically and radiographically at 12 months. The study aims to identify objective, measurable biomarkers that can improve pulpal diagnosis and guide clinical decision-making in vital pulp therapy.

Measurement of Pro-resolving Inflammation Biomarkers in Saliva, Gingival Fluid, and Dental Pulp in Patients With Symptomatic Pulpitis and Healthy Controls

This observational study aims to better understand inflammation inside the dental pulp (the inner tissue of the tooth) in patients with symptomatic pulpitis compared with healthy individuals. Researchers will measure inflammation-related biomarkers in saliva, gingival fluid, and dental pulp samples to determine whether these substances reflect the level of inflammation. The study also evaluates whether saliva and oral fluids could be used as simple, non-invasive tools to detect and monitor pulp inflammation. We hypothesize that patients with pulpitis will show different biomarker levels compared with healthy controls.

Clinical and Radiographic Evaluation of Primary Endodontic Treatment and Non-surgical Endodontic Retreatments

Background: Pulpitis and apical periodontitis are inflammatory conditions of the dental pulp and periapical tissues, primarily caused by microbial invasion. The global prevalence of pulpitis is considered high but underestimated, as up to 40% of cases are asymptomatic. Similarly, the prevalence of apical periodontitis varies widely (16-86%) depending on population characteristics, systemic conditions, and socioeconomic status, and it is reported to be higher in hospital settings. Endodontic therapy aims to disinfect and seal the root canal system, promoting healing of apical periodontitis or maintaining periapical health. Reported success rates for primary and non-surgical retreatment procedures are comparable (75% and 77%, respectively), though outcomes tend to be more favorable in vital teeth compared to those with apical periodontitis (84% vs. 75%). Despite the widespread use of endodontic therapy, few studies have assessed treatment outcomes in a hospital setting. Objectives: The primary aim of this prospective study is to evaluate the success of primary and non-surgical endodontic retreatments performed in a hospital environment. Secondary objectives include assessing (1) the survival of treated teeth, (2) patient-related outcomes (PROs), and (3) the influence of systemic diseases or ongoing therapies on treatment outcomes. Methods: This is a monocentric, prospective, observational, study to be conducted at the Dental Clinic of the A. Gemelli University Hospital, Rome. Adult patients (\>18 years) requiring primary or non-surgical endodontic retreatment due to symptomatic or asymptomatic irreversible pulpitis, apical periodontitis, or acute/chronic abscesses will be enrolled after providing written informed consent in accordance with the Declaration of Helsinki. Exclusion criteria include inability to complete follow-up, vertical root fractures, advanced periodontal disease requiring extraction, pregnancy or breastfeeding, and inability to provide informed consent. Patients will undergo standard endodontic therapy according to the European Society of Endodontology (ESE) guidelines. Clinical and radiographic evaluations will be performed preoperatively, intraoperatively, and postoperatively. Radiographic assessments will be based on the Periapical Index (PAI), and follow-ups will occur at 6 months, 1 year, and annually for up to 4 years, with a final clinical follow-up at 5 years. Patient-related outcomes will be evaluated using the Numerical Rating Scale (NRS-12) for pain and the Oral Health Impact Profile (OHIP-14) questionnaire before treatment and at 1, 3, and 7 days post-treatment. Outcome Measures: The primary endpoint is the rate of endodontic success, defined by the absence of clinical symptoms (pain, swelling, sinus tract, tenderness) and radiographic healing or maintenance of periapical health (Periapical Apex Index, PAI). Secondary endpoints include the incidence of postoperative complications, survival rate of treated teeth, associations between systemic conditions and endodontic outcomes, and patient-reported outcome measures. Statistical Analysis: The sample size was calculated according to Lachin et al., assuming an expected success rate of 85%, a 5% margin of error, and 90% power, resulting in a minimum of 74 patients. Qualitative variables will be expressed as frequencies and percentages, while quantitative variables will be summarized as mean ± SD or median, depending on distribution. Normality will be tested with the Kolmogorov-Smirnov test. Associations between categorical variables will be evaluated using Pearson's χ² or Fisher's exact test, and continuous variables with Student's t-test, Mann-Whitney U, ANOVA, or Kruskal-Wallis tests as appropriate. Repeated measures ANOVA or Friedman tests will be applied to detect longitudinal changes. Mixed-effects models ((G)LMM) will be used to analyze changes in PAI, NRS-12, and OHIP-14 over time while adjusting for confounders. Logistic regression will identify independent predictors of success, and Kaplan-Meier survival curves (log-rank test) will estimate tooth survival over follow-up. Significance will be set at p \< 0.05. Statistical analyses will be performed using IBM SPSS Statistics v25.0 (IBM Corp., Armonk, NY, USA). Expected Results and Conclusions: This study is expected to provide data on the clinical and radiographic success rates of primary and non-surgical endodontic treatments performed in a hospital setting. It will also clarify the impact of systemic diseases and patient-related factors on treatment outcomes. The findings may help optimize clinical protocols and patient management strategies in hospital-based endodontic care, contributing to evidence-based improvement of dental services and patient quality of life.

Comparison of Aquaporin -4, -5, -9 and IL-8 Levels in GCF, Dentin Fluid and Pulp Samples

This study aimed to compare the changes in AQP -4, -5, -9, and IL-8 levels in pulp tissue, GCF, and dentin fluid samples routinely obtained during the treatment of healthy and symptomatic teeth diagnosed with irreversible pulpitis and investigate whether there is a correlation between them. A total of 70 patients aged 18-64 years with healthy (Group 1) and symptomatic irreversible pulpitis (Group 2) diagnosed at Kırıkkale University, Faculty of Dentistry, Department of Endodontics who will undergo routine root canal treatment will be included in the study, with a minimum of 35 participants for each group. Before starting treatment, DOS samples will be taken from healthy, symptomatic, irreversible pulpitis-diagnosed teeth and teeth contralateral to these teeth. A dentin fluid sample will be taken by holding the membrane on the dentin surface, and the pulp tissue will be removed and transferred to Eppendorf tubes. The treatment process will be completed by applying routine root canal procedures to the teeth. The samples' Aquaporin -4, -5, -9, and IL-8 levels will be analyzed by specific enzyme-linked immunosorbent assay (ELISA).

Effectiveness of Pulpotomy vs. Root Canal Treatment in Extremely Deep Caries

Recent clinical trials comparing pulpotomy versus root canal treatment (RCT) have shown promising outcomes; however, the current evidence lacks generalisability to general practitioners. It remains to be elucidated whether these favourable results can be replicated in a primary care setting. This study aims to address that gap by involving senior dental students undergoing supervised university education and training, with the potential to inform future best practice guidelines and promote the adoption of vital pulp therapy (VPT) as a predictable treatment alternative in the general dental population. The clinical procedure involves complete caries-free excavation carried out under rubber dam isolation. After confirming vital pulp status-demonstrated by bleeding upon entry, participants will be randomised to receive one of two treatments: RCT or full pulpotomy. Outcomes will include clinical and radiographic success or failure of the intervention at 12 months. Additionally, patient-reported outcomes will be collected, specifically pain experienced and the use of analgesia during the immediate post-operative period (days 3 and 7).

The Effect of Genetic Polymorphisms on the Success of Vital Pulp Therapy

This study employs saliva-based DNA analysis to investigate the effect of genetic polymorphisms, particularly SNPs in MMP, TIMP, TNF-α, and BMP genes, on the success of vital pulp therapy in permanent teeth with pulpitis, assessed through clinical follow-up.

Success of Endodontic Treatment With Different Obturation Techniques and Sealer Cements

The present study aims to compare the radiographic success of endodontic treatment using Orstavik's criteria between two sealers: AH Plus (Dentsply DeTrey, Konstanz, Germany) and Neosealer Flo (Avalon Biomed, Bradenton, Florida, USA), as well as between two obturation techniques: continuous wave and single cone. The study includes 270 patients, with a minimum follow-up period of 6 months. Clinical and radiographic variables will be assessed, including quality of obturation, lesion healing, and restoration. The study seeks to determine if the use of bioceramic sealer is effective regardless of the obturation technique used, highlighting the importance of clinical follow-up to evaluate endodontic treatment success.

Postoperative Pain Evaluation After Obturation With Different Sealers

This study aims to evaluate the incidence and intensity of postoperative pain in patients undergoing root canal treatment on teeth diagnosed with pulpitis, pulp necrosis, or with previous endodontic treatment. Teeth will be obturated using either bioceramic or resin-based sealers. The primary objective is to determine whether the type of sealer significantly influences the level of postoperative pain as reported by patients. Pain intensity will be assessed using the Visual Analogue Scale (VAS) at three time points: immediately after treatment, 24 hours, and 72 hours postoperatively. The findings are expected to provide clinical insight into which obturation material may be more effective in minimizing postoperative discomfort.

The Effect of Different Risk Factors on the Success Rate of VPT

This study aims to evaluate the effectiveness of various vital pulp therapy (VPT) methods, such as direct pulp capping, partial pulpotomy, and total pulpotomy, in maintaining pulp vitality following pulp exposure. It explores the success rates of these treatments compared and investigates co-factors influencing these rates, including age. This prospective cohort study involves patients over 18 with restorable teeth and exposed pulp chambers. Success is measured through clinical and radiological criteria over a follow-up period of up to four years. The study also aims to identify if there's an age threshold affecting the preference for VPT over root canal therapy.

Clinical and Radiographic Evaluation of Propolis As a Hemostatic Agent for Pulpotomy of Mature Permanent Molars with Irreversible Pulpitis Using Two Different Dressing Materials

The goal of this clinical trial is to assess the effectiveness of propolis as a hemostatic agent in pulpotomy for adult permanent molars, compared to sodium hypochlorite (NaOCl). It also examines how bioceramic putty performs against mineral trioxide aggregate (MTA) in vital pulp therapy for cases of irreversible pulpitis. Participants will be divided into four groups (15 patients each): * Propolis + bioceramic putty * Propolis + MTA * Sodium hypochlorite + bioceramic putty * Sodium hypochlorite + MTA The Investigator will record the bleeding time and postoperative pain will be recorded. The researcher will assess the clinical and radiographic outcomes for success at 1, 3, and 6 months.

Caries Location and Its Effect on the Success Rate of Indirect Pulp Treatment in Primary Molars

The following study will be created to evaluate how the location of caries affects the effectiveness of indirect pulp treatment in primary molars. aiding in the development of evidence-based recommendations for pediatric dentists.

Evaluation of Pulpotomy Using Two Different Agents in Mature Anterior Teeth With Pulpitis

the study will evaluate the clinical and radiological success of mature permanent anterior teeth pulpotomy in children and adolescents with signs of pulpitis using two different Biomimetic materials (NeoPutty® and Biodentine™) as a pulp dressing material in comparison to root canal treatment at 3, 6, 9 and 12 months follow up.