Clinical Research Directory

Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences

Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque. Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.

Orthodontic Varnish Microbiology Study

Orthodontic treatment is common in teenagers, which typically involve the attachment of metal brackets to the teeth. These brackets often impede proper oral hygiene, leading to plaque accumulation and the development of white spots lesions (the early stage of cavity development). Our study aims to investigate the efficacy of different commercially available fluoride varnishes to treat these white spot lesions after the completion of orthodontic treatment and evaluate their effect on the oral microbiome. Target enrollment is 120 subjects. The study will follow a split-mouth design, with each subject receiving different treatment on the left and right sides of their mouth. The subjects will be randomized into 3 groups, with each group receiving two of the following three options: placebo varnish, traditional sodium fluoride varnish, and a resin-modified glass ionomer light-cured fluoride varnish. There will be 4 total visits for this study: Baseline (day 0): Oral health assessed, plaque collected, intraoral photos taken, dental cleaning performed, DiagnoDent measurements taken, varnishes applied T1 (day 30): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T2 (day 90): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, varnishes reapplied T3 (day 180): Oral health assessed, plaque collected, intraoral photos taken, DiagnoDent measurements taken, dental cleaning performed Participants will be instructed to use regular fluoridated toothpaste and floss twice per day for the duration of the study.

Clinical Performance of Different Ion-Releasing Restorative Systems in Class II Cavities

Different ion-releasing restorative systems will be applied in class II cavities then their clinical performance will be evaluated and compared

Effect of Ozone Therapy on Remineralization of Initial Caries Lesions in Children

Initial caries lesions can be managed using non-invasive treatment approaches that promote remineralization and prevent lesion progression. Ozone therapy has been suggested as an adjunctive treatment because of its antimicrobial properties and its potential to enhance remineralization. This randomized controlled clinical trial aims to evaluate the effect of ozone therapy on the remineralization of initial caries lesions in children. Participants will be randomly assigned to receive either ozone therapy followed by application of a remineralizing gel or application of the remineralizing gel alone. Changes in lesion status will be assessed over time using clinical and optical evaluation methods. The results of this study may contribute to the development of evidence-based minimally invasive approaches for the management of early caries lesions in pediatric patients.

Comparing Stainless Steel Crowns With Prefabricated Resin Crowns in Primary Molar Teeth

The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.

Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics

The goal of this clinical trial is to learn which type of oral health education works best to help 12-18-year-old participants with fixed orthodontic appliances (braces) keep their mouths healthy. The main questions it aims to answer are: Which method of oral hygiene instruction-video-based, written, or face-to-face education-is most effective in improving oral health? Do these education methods help lower dental plaque and gum inflammation during orthodontic treatment? Researchers will compare the three groups of participants who receive different types of oral hygiene training to see which method leads to the best oral health results. Participants will: Receive one of three types of oral hygiene instruction (video, written, or in-person). Continue their regular orthodontic care and brushing routine. Have their oral health checked at different times during the study to measure changes in plaque and gum health. The study hopes to identify the most effective and practical way to teach young orthodontic patients to keep their teeth and gums healthy while wearing braces.

Dental Caries and Oral Hygiene Status in Children With Specific Learning Disabilities

This study aims to evaluate dental caries and oral hygiene status in children aged 7-12 years with specific learning disabilities (SLD) and to compare the findings with healthy children. Clinical oral examinations, including dmft/DMFT, ICDAS II, Plaque Index, and Gingival Index assessments, will be performed. In addition, questionnaire-based evaluations of oral hygiene habits, dietary habits, and parental supervision during toothbrushing will be conducted.

Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities

this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.

3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars.

The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are: Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types? Participants will: Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy. Attend follow-up visits for clinical evaluation over 12 months.

3-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal Adaptation

Study Protocol Background The use of partial coverage restorations had increased significantly as a conservative alternative to full-coverage crowns, particularly in cases where the coronal tooth structure was extensively damaged and insufficient dentin remained to support direct restorations. These restorations were designed to preserve sound tooth structure while reinforcing weakened teeth affected by caries or fracture. Depending on the extent of cuspal coverage, partial coverage restorations were classified into inlays, onlays, and overlays. With the advancement of digital dentistry, computer-aided design and computer-aided manufacturing (CAD/CAM) technologies had become widely adopted, enabling the fabrication of restorations with improved precision, mechanical performance, and esthetics. Various restorative materials were introduced, including glass ceramics, polycrystalline ceramics, and resin-matrix ceramics (hybrid ceramics). Hybrid ceramics, such as Vita Enamic, combined a ceramic network reinforced by a polymer phase, providing enhanced mechanical properties and favorable clinical behavior. More recently, additive manufacturing technologies such as 3D printing had been introduced for the fabrication of definitive single-tooth restorations. However, limited evidence was available regarding their long-term performance, particularly in comparison with subtractive CAD/CAM materials. Additionally, marginal adaptation and bond strength were critical factors influencing clinical success, as failures were often initiated at the tooth-restoration interface. Therefore, this study was designed to evaluate and compare the clinical and laboratory performance of 3D printed restorations, milled CAD/CAM hybrid ceramics, and indirect resin composite onlays. \- Aim of the Study The study aimed to evaluate and compare the following: 1. The 2-year clinical performance of 3D printed, milled CAD/CAM hybrid ceramic, and indirect resin composite onlays. 2. The marginal and internal adaptation of the tested restorative materials. 3. The micro-tensile bond strength to dentin. - Clinical Part Summary A randomized controlled clinical trial was conducted following CONSORT guidelines. Patients were selected from the outpatient clinic of the Faculty of Dentistry, Mansoura University. Inclusion criteria required the presence of at least three posterior teeth with weakened cusps indicated for indirect onlay or overlay restorations, good oral hygiene, and healthy vital teeth with no symptoms. Patients with severe bruxism, systemic instability, or allergies to study materials were excluded. Each patient provided informed consent prior to participation, and ethical approval was obtained from the institutional review board. A split-mouth design was used, and teeth were randomly assigned into three groups according to the restorative material. Standardized tooth preparations were performed under local anesthesia using adhesive onlay preparation principles. Impressions were taken, and provisional restorations were placed. Final restorations were fabricated using either milling or 3D printing techniques depending on the material type. All restorations were cemented using resin cement following manufacturer instructions under rubber dam isolation. Clinical evaluation was performed at baseline, 1 month, 6 months, 12 months, 18 months, and 24 months using modified FDI criteria, assessing aesthetic, functional, and biological properties. \- Laboratory Part Summary For the in vitro component, 60 freshly extracted human molars were collected from patients attending the Faculty of Dentistry, Mansoura University. Teeth were cleaned, disinfected, and stored appropriately until use. Teeth with cracks, caries, or structural defects were excluded under stereomicroscopic examination. Standardized Class II onlay preparations were performed on all specimens using a uniform protocol. Impressions were taken, and restorations were fabricated indirectly in a dental laboratory according to manufacturers' guidelines. Specimens were randomly assigned into three groups corresponding to the tested materials. Marginal and Internal Adaptation Marginal adaptation was evaluated using epoxy resin replicas examined under scanning electron microscopy (SEM). Internal adaptation was assessed after sectioning the specimens longitudinally through the restoration axis. Gold sputter-coated samples were analyzed under SEM to measure internal gaps and adaptation quality. Micro-tensile Bond Strength Test Restored teeth were sectioned into small beams with a cross-sectional area of approximately 1 mm². Each specimen was tested using a universal testing machine at a crosshead speed of 0.5 mm/min until failure occurred. Micro-tensile bond strength values were calculated by dividing the failure load by the bonded surface area. \- Statistical Analysis Data were recorded and analyzed using statistical software.

Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools

Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three to fifty percent of adult population presented at least one untreated caries and more than 50% of French population are affected by severe periodontitis. These diseases affect dental organ or periodontal attached system but could have negative impact on general health, quality of life, word and individual well-being. Association between chronic diseases as diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well investigated. Dental and periodontal diagnosis is dependent of various clinical parameters time consuming and dependent operator. It represents a public health challenge. Informatic analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today, any software or algorithm allow automatized detection, clinical qualitative or quantitative indices recording while these informations are present in numeric models

Advancing Water Security: A Community Participatory School-Based Hydration Intervention

The goal of this study is to determine the effectiveness and sustainability of a community-participatory hydration intervention over 3 years within a district that has newly installed hydration stations and is operating under a policy designed to enhance heathy hydration practices and promote equitable access to drinking water.

Oral-Spray Bacillus Spore Probiotic in Preventing and Supporting Treatment of Dental Caries in Children

Despite advances in oral health care, cavities remain highly prevalent worldwide, especially among children. Conventional treatment methods focus on removing damaged tooth tissue but fail to completely eliminate or control pathogenic bacteria in the oral cavity, leading to a high risk of caries recurrence in the same or adjacent teeth. Probiotics are a promising biological therapy that can help restore balance in the oral microbiome. Among probiotics, Bacillus species are unique because they form spores that make them stable under harsh conditions, such as heat and storage. They can also produce enzymes and natural compounds with antibacterial, anti-inflammatory, and protective effects. These features make Bacillus probiotics strong candidates for oral health applications. This study is designed to evaluate the safety and efficacy of an oral-spray probiotic containing Bacillus subtilis ANA48 and Bacillus clausii ANA39 (LiveSpo® Smile CARE) in preventing and supporting the treatment of tooth decay in children. We hypothesize that this probiotic spray, when used regularly, will be safe and well-tolerated, while effectively reducing harmful bacteria in the mouth, preventing the progression of cavities, and improving overall oral health. Study Design: * Sample Size: 130 participants * Study Location: a primary school in Hanoi, Vietnam Intervention Description: A total of 130 eligible participants will be randomly assigned to two groups (n = 65 per group). Placebo Group will receive a 0.9% NaCl physiological saline, spray twice daily (morning and afternoon). Each application consists of two sprays at three sites (both dental arches and the front teeth), for a total of six sprays per use, continued for three consecutive months. Smile Care Group will receive an oral-spray probiotics containing ≥ 1 billion CFU/mL × 20 mL of Bacillus subtilis and Bacillus clausii (LiveSpo Smile CARE). The dosage, frequency, and duration of use will be the same as in the placebo group. All participants will receive the same standard dental care throughout the study, including the use of identical toothpaste, supervised weekly fluoride rinsing with 0.2% sodium fluoride (NaF), and scheduled follow-up visits. The probiotic and placebo sprays will be packaged in blinded bottles and administered according to the study protocol to maintain objectivity. Study Duration: 12-18 months

Evaluation of Prefabricated CAD/CAM PEEK Crowns Used in Primary Molars

Fifty healthy cooperative children will be randomly allocated to two groups. Group I (test group) will receive CAD/CAM PEEK crowns, while group II (control group) will receive SSC. The crowns will be evaluated clinically and radiographically.

The Effects of Sodium Fluoride and Chlorhexidine Use on Salivary IL-6 and Matrix Metalloproteinase Levels in Children With Active Caries

This study aims to compare salivary IL-6, MMP-8, MMP-9, and TIMP-1 levels between healthy children and caries-active children, and to evaluate the effects of 5% sodium fluoride (NaF) varnish and 2% chlorhexidine (CHX) used in caries prevention on these biomarkers. The study will be conducted at Alanya Alaaddin Keykubat University, Faculty of Dentistry, Department of Pediatric Dentistry. Informed consent will be obtained from children and their parents/guardians. Investigator calibration will be performed using Cohen's kappa method prior to data collection. Sample size was calculated assuming 80% power (1-β = 0.80), α = 0.05, and Cohen's d ≈ 0.8, resulting in 20 participants per group using G\*Power 3.1 software. Study groups: Group A: 5% NaF varnish. Group B: 2% CHX + 5% NaF varnish. Group C: Standard oral hygiene education (negative control). Group D: Caries-free children (biological reference; baseline saliva sampling only). Saliva samples will be collected at T0 (baseline), T1 (30 minutes post-application), and T2 (1 month). Unstimulated whole saliva will be collected, centrifuged at 5,000 g for 10 minutes at 4°C, and stored at -80°C. IL-6, MMP-8, MMP-9, and TIMP-1 levels will be measured using CE-marked/FDA-approved human saliva ELISA kits.

Comparison of LSTR and Pulpectomy in Primary Molars of Pediatric Patients (LSTR-PULP)

This study aims to compare the effectiveness of Lesion Sterilization and Tissue Repair (LSTR) with conventional pulpectomy in treating pulpal lesions in primary molars of pediatric patients aged 4 to 10 years. LSTR is a minimally invasive method that uses antibiotic paste to disinfect infected tissue without full canal instrumentation. Children participating in this study will receive either the LSTR technique or standard pulpectomy, and the clinical and radiographic success of both treatments will be evaluated over a 12-month period. The goal is to determine whether LSTR is a safe and effective alternative to pulpectomy in primary teeth.

Retention and Caries Prevention of Giomer Sealant With or Without Diode Laser Pre-treatment: A Randomized Controlled Trial

This randomized controlled trial evaluates the effect of diode laser pre-treatment on the retention and caries prevention of giomer-based fissure sealants in young adults aged 17-22 years. The study compares sealant application with and without diode laser conditioning on molars with ICDAS 0-2 fissures over a 12-month follow-up period. Primary outcome is sealant retention using Simonsen's criteria, while secondary outcome is caries prevention using modified USPHS criteria. The study hypothesizes that diode laser pre-treatment may improve sealant retention and enhance caries prevention by modifying enamel surface characteristics and improving sealant penetration.

Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children

The goal of this clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. The trial will determine whether any single cement offers superior retention, gum health, or marginal sealing compared to the others over a 3-year period. Main Questions: The study aims to answer the following: Are conventional glass ionomer cement (GIC), bioactive resin-modified glass ionomer cement (BioCem™), and self-adhesive resin cement (SARC) equivalent in retaining prefabricated zirconia crowns on primary incisors over 36 months? Do these cements differ in their effect on gingival health, plaque accumulation, or marginal discoloration around the cemented crown? Comparison: Researchers will compare three parallel groups of children whose primary incisors are restored with identical prefabricated zirconia crowns but cemented with one of the three different luting cements. Participants will: Receive a clinical and radiographic dental examination at screening. Undergo placement of one or more prefabricated zirconia crowns on primary anterior teeth using their randomly assigned cement. Return to the clinic for blinded follow-up evaluations at 12, 24, and 36 months for assessment of crown retention, gingival health, plaque, and marginal staining.

QLF and Digital Imaging for Caries Activity Assessment After Orthodontic Treatment

This prospective longitudinal observational study aims to evaluate the diagnostic performance and agreement of Smartphone photography, intraoral 3D imaging, Quantitative Light-Induced Fluorescence Digital (QLF-D), and ICDAS clinical criteria for assessing non-cavitated caries lesion activity in post-orthodontic patients under a preventive follow-up program. Thirty participants aged 11 to 46 years with active initial caries lesions will be followed for three months. Clinical examinations, QLF-D imaging, smartphone photographs, and intraoral 3D scans will be obtained at baseline and follow-up visits combined with professional prophylaxis and oral hygiene reinforcement. The study will analyze changes in lesion activity, fluorescence parameters, and surface characteristics over time, as well as the agreement and diagnostic performance among the evaluated methods.

Longitudinal Evaluation of Minimally Invasive Protocols for Dental Caries in Brazilian Schoolchildren

This multicenter longitudinal interventional study aims to evaluate minimally invasive protocols for the prevention and control of dental caries in Brazilian schoolchildren under routine public health conditions. In the first phase, 50,000 children aged 6 to 12 years from public schools in five Brazilian cities will undergo dental screening using ICDAS criteria and receive preventive and educational oral health measures. In the longitudinal treatment phase, 2,500 children diagnosed with active carious lesions will be managed according to ICDAS-based minimally invasive treatment protocols. Participants will be followed every three months for up to 24 months.

Obesity and Oral Diseases in Adult Patients

Overweight and obesity are among the major chronic disorders of the 21st century and one of the fastest growing health problems worldwide. Obesity is accompanied by a state of low-grade inflammation which may contribute to the occurrence of diabetes mellitus, cardiovascular disease, hypertension, stroke, and certain cancers. Furthermore, obesity has been associated with oral health problems as hyposalivation, dental caries and periodontitis. The management and treatment of obesity is outlined in clinical guidelines from American Association of Clinical Endocrinologists/American College of Endocrinology and European Association for the Study of Obesity. The cornerstone is life-style modification programs aiming to reduce energy intake and increase physical activity, referred to as conservative treatment. All patients must undergo a thorough systematic work-up. The work-up concludes in a final multi-disciplinary meeting with a concrete individualized plan on how sustained weight-loss is to be achieved; either by a non-surgical or a surgical approach (Bariatric surgery). Periodontitis is cited to be the sixth most prevalent chronic condition globally. The mechanisms by which obesity affects the periodontal tissues is poorly understood, and the understanding of the key role of adipocytes in the inflammatory response to infections is crucial in comprehending how periodontal disease susceptibility may be modified in obese individuals. The main objectives of the present research project are to explore the association between obesity and oral diseases and further, to assess how weight changes following non-surgical and surgical interventions of obese patients may affect the cariological and periodontal health status. Four hundred patients referred to the Obesity Centre at Haukeland University Hospital, Norway will consecutively be screened and invited to participate in this prospective cohort study. At baseline, detailed medical and oral data will be obtained from health forms, questionnaires, clinical examinations, and by consulting the patient's care team. Following baseline examination, all patients will undergo a thorough systematic work-up consisting av interviews and consultations concluding in a final multi-disciplinary individualized non-surgical or surgical treatment plan on how sustained weight-loss can be achieved. New sets of medical, oral, and molecular data will be collected at 3-, 12- and 18-month following non-surgical/surgical interventions.

Clinical Study Evaluating Solventum™ Vitrebond™ Pulp Protect Liner/Base for Direct Capping of Pulpal Exposure

This research study is looking at the safety and effectiveness of Solventum™ Vitrebond™ Pulp Protect Liner/Base for direct pulp capping (DPC) on permanent teeth that have pulp exposure due either to deep cavities, trauma, or other accidental causes. Dental pulp is the part of the tooth that contains the nerves, blood vessels, and cells that keep teeth healthy. The DPC procedure is done by dentists to help preserve tooth health if there is pulp exposure during the tooth restoration or due to trauma. Participants must have at least one permanent tooth with pulp exposure that needs DPC to be eligible for the study.

3D Scanning as an Advanced Tool for Identifying Tooth Lesions in Children

This study focuses on assessing dental caries, erosive tooth wear, and fluorosis in primary teeth using a 3D intraoral digital scanner. The investigator will validate findings using three key indices: ICDAS (for caries), BEWE (for erosive wear), and TF (for fluorosis). Teeth will be cleaned and examined visually using dental tools and light. After visual checks, teeth will be scanned with a 3D intraoral scanner. Children aged 3-12 years with fully erupted primary teeth, seeking dental treatment at the Department of Pediatric Dentistry, Indiana University School of Dentistry. The visual examination and digital scanning will be performed just once and during the dental appointment at the clinic of Pediatric Dentistry following the protocols used in the clinical routine. It is expected to complete the visual examination and the digital scanning in 30 minutes.

Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars

This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using revised FDI criteria.