Clinical Research Directory

Salivary Cytokines, MMP-8 and Dental Caries in Osteoporosis Patients

This study examines saliva samples from patients with osteoporosis. The levels of cytokines and Matrix Metalloproteinase-8 (MMP-8) enzyme in saliva will be measured. Additionally, the dental caries status of participants will be evaluated. The aim of this study is to understand the relationship between osteoporosis and oral health. Only saliva samples will be collected from participants; no treatment or medication will be administered.

Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars

This randomized clinical trial aims to evaluate and compare the clinical and radiographic performance of 38% silver diamine fluoride (SDF) with 38% silver diamine fluoride followed by light curing in children with carious primary molars. Children aged 4-8 years with active caries in mandibular primary molars will be included in the study. One group will receive 38% silver diamine fluoride followed by LED light curing, while the comparison group will receive 38% silver diamine fluoride without light curing. The primary outcome is postoperative pain, assessed using the visual analogue scale (VAS). Secondary outcomes include caries lesion arrest, lesion extension and severity, signs of infection, pain on percussion, pathological tooth mobility, and radiographic changes. Participants will be followed for 12 months. The findings may help determine whether adding light curing to silver diamine fluoride application improves the management of caries in primary molars.

In-situ Clinical Trial Assessing Ability to Detect and Monitor Active Caries and Their Remineralization

The goal of this clinical trial is to evaluate whether BlueCheck® can accurately detect and monitor early-stage dental caries (tooth decay) and their remineralization in adults. Participants will wear partial dentures with partially demineralized human enamel specimens. The main questions it aims to answer are: * Can BlueCheck® reliably detect early carious lesions with high sensitivity and specificity? * Does BlueCheck® visually reflect changes in remineralized enamel lesions? BlueCheck® results will be compared against standard diagnostic methods (e.g., Nyvad criteria, Diagnodent readings, surface microhardness) to see if BlueCheck® provides an objective, accurate, and visual method of detecting and monitoring early-stage caries. Participants will: * Wear a modified lower partial denture with four mounted enamel specimens for 28 days. * Use only the study-provided fluoride containing toothpaste * Attend weekly clinic visits for removal and laboratory analysis of one enamel specimen per week. * Undergo regular oral health checks and provide diary entries tracking brushing and any adverse events.

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.

Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics

There is limited data available on VITA AMBRIA glass ceramic , so this study is conducted to investigate the esthetic parameters of this new glass press system.

Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings

This study will assess the effectiveness of erythritol and xylitol in suppressing biofilm activity, using both within-subject and between-group comparisons.

Color Stability of Darkly Discolored Arrested Caries Lesions Following Bleaching Treatment

This observational study evaluated the color stability of darkly discolored arrested caries lesions (DDACL) on anterior teeth following in-office bleaching with 40% hydrogen peroxide, in comparison with healthy teeth. Tooth color (spectrophotometer, CIELAB, CIEDE2000), laser fluorescence (DIAGNODent Pen), ICDAS II codes, and patient and clinician color satisfaction were assessed at baseline, immediately after bleaching, and at 1 week and 3 months.

Oral Health Knowledge and Caries Experience in Adults

This cross-sectional study assessed the level of oral health knowledge and its relationship with caries experience, independently of age and sex, in adult patients attending a university dental clinic in Gran Canaria (Spain). Adults aged 19 years or older completed a validated 20-item oral health knowledge questionnaire and underwent a standardized clinical dental examination, complemented by a same-day panoramic radiograph obtained as part of routine care, to record the Decayed, Missing, and Filled Teeth (DMFT) index according to World Health Organization criteria. The association between knowledge and the DMFT index was analyzed using negative binomial regression adjusted for age and sex.

Oral Health Intervention in Adult Primary Care

This study is a Stage III cRCT to test the efficacy of multi-level interventions at the practice- and provider-level to address low dental utilization (attendance) among Medicaid-enrolled older adults 55 years or older attending non-urgent primary care visits (PCV) in MetroHealth practice settings. Twelve practices will be randomized into two arms: A) Intervention arm will receive the multi-level intervention that includes: 1. Practice-level: EHR changes to include: ask, advise, assess, and connect (AAAC) strategies; 2. Provider-level: Medical staff (MA, nurse): Training in the AAAC process and complete AAAC for enrolled older adults; Clinicians (physician/nurse practitioner): CSM-based education (didactic), skills training (video training with standardized patients), and view completed AAAC in EHR to deliver core oral health (OH) facts to older adults, reinforce importance of dental visits, and document in EHR that OH facts were delivered. B) Control arm will receive, at the provider-level only (clinicians), non-theory-based information about retaining a healthy mouth using the ADA Mouth Healthy Series and deliver standard OH care for patients. Older Adults will be followed at 12 months and 24 months to determine if the participant had any dental attendance. The primary objective is to test the efficacy of the practice level EHR strategy to ask \[OH risk assessment\], advise \[going to dentist\], assess \[willingness for referral\], and connect \[eReferral, resources\] together with clinician theory-based education to communicate OH facts versus clinician alone (standard oral health care) in increasing dental attendance in primary care settings. The secondary objectives are to assess oral hygiene behavior, Geriatric Oral Health Quality of life, biometric measures (BP, serum cholesterol, blood glucose, hbA1c) abstracted from EHR data, potential mediators and moderators to investigate pathways that affect the primary and secondary outcomes, and assess implementation strategies: adoption, reach, fidelity, and maintenance of providers and practices that affect older adult primary and secondary outcomes. The hypothesis is that medical staff completing the AAAC strategy and clinicians with improved OH knowledge (chronicity, systemic effects) will deliver consistent oral health messaging to older adults at PCVs that will result in increased preventive and restorative dental utilization compared to those providers delivering standard care.

The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth

Dentists commonly use bitewing radiographs (dental X-rays) together with a visual-tactile (clinical) examination to detect cavities between the back teeth. While bitewing radiography can identify some lesions that are not visible during a visual-tactile examination, it is unclear whether its use improves outcomes that are important to patients. Radiographs may lead to the detection and treatment of lesions that would not otherwise cause problems, resulting in additional costs and dental procedures. Despite the widespread use of bitewing radiography in adult dental care, its effects on treatment decisions, patient outcomes, and cost-effectiveness have not been evaluated in randomized controlled trials among adults. Therefore, the investigators aim to conduct a randomized controlled trial to compare two strategies for caries diagnosis in young adults: visual-tactile examination alone and visual-tactile examination supplemented with bitewing radiography. Participants will undergo a standardized oral examination and will be randomly assigned to one of the two diagnostic strategies. Treatment recommendations will be based on the findings obtained using the allocated diagnostic approach and will follow predefined treatment criteria. The investigators will compare the effects of these diagnostic strategies on patient-important outcomes, treatment decisions, resource use, examination time, and cost-effectiveness. The results of this study will provide evidence on whether including bitewing radiography in routine caries diagnostics offers benefits that justify its additional costs and radiation exposure in young adults.

This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.

The goal of this feasibility study is to evaluate the study protocols of a future larger clinical study. In this study children, aged 3-7 years, with caries lesions in their primary molars will be treated with stainless steel crowns or conventional fillings. Treatment results will be compared and participating children, parents and dentist will be asked questions about the treatments and the study protocol. The main questions it aims to answer are: * Children, parents and dentists´ acceptance of study protocols * Practical/logistical issues for the public dental clinics during the study * Find out if there is a difference in treatment result between stainless steel crowns and conventional fillings Researchers will compare treatment with stainless steel crowns to conventional fillings to see if there are any difference in treatment results and how children and parents view the treatment. Participants will receive dental treatment and follow up controls at their public dental clinic. Children, parents and participating dentist will be asked to fill out surveys before, during and after treatment and follow up controls

Prevalence of Caries and Periodontal Disease and Their Correlation in a Dental School in Egypt

In Egypt, oral diseases such as caries and periodontal disease are particularly burdensome, with implications for overall health and quality of life. The World Health Organization (WHO) has reported high prevalence rates for these conditions, underscoring the urgent need for targeted research and intervention . This study focuses on understanding the burden of these diseases in a dental school setting, which serves a diverse patient population, and explores their potential interrelationship.

A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children

This study, titled "A Randomized Controlled Trial to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children" (Study Number: ATSU-YI-NSF 2025), is sponsored by Young Innovations and conducted at the Arizona School of Dentistry \& Oral Health (ASDOH) at A.T. Still University in Mesa, Arizona, under Principal Investigator Marc Shlossman, DDS, MS. The primary objective is to validate and compare the cariostatic efficacy of Nano Silver Fluoride (ClearDefense®) against Silver Diamine Fluoride (AdvantageArrest®) in pediatric dental patients with active carious lesions on primary molars and first permanent molars. Designed as a non-inferiority trial, it evaluates whether Nano Silver Fluoride provides comparable caries-arresting effects while assessing patient, parent, and provider acceptance, tooth color changes, and overall product safety. The trial is structured as a six-month, double-blind, parallel-group, single-site randomized controlled study with an optional twelve-month follow-up visit. To achieve a target sample size of 60 evaluable subjects (30 per treatment group) while accounting for a projected 20% dropout rate, a total of 72 pediatric participants will be recruited. Subjects are randomly assigned to treatment arms using an online random number generator. Allocation concealment and double-blinding are maintained by a third-party study coordinator who prepares treatment supplies on preset trays, keeping trial investigators, outcome examiners, and participants masked to product identity. Eligible participants include medically healthy children aged 6 to 10 years who present with at least one primary molar or permanent first molar containing active occlusal or proximal caries classified as ICDAS II Stage 3 through 6. Children and their parents or guardians must read and understand English or Spanish, provide written assent and consent, and agree to attend all required study visits. Exclusion criteria apply to children with known allergies to fluoride or silver, significant systemic conditions, ulcerative oral lesions, or conditions reducing salivary flow, as well as target teeth with loose roots, pulpal involvement, or existing restorations. At the baseline visit, active carious lesions receive a single topical application of either ClearDefense® (3% sodium fluoride + 0.2% silver ion) or AdvantageArrest® (38% silver diamine fluoride) for at least one minute. Mandatory study appointments occur at baseline, 3 months, 6 months, and an optional 12 months, incorporating clinical oral examinations, tooth cleaning, radiographs, intraoral photographs, and digital tooth shade assessments using a Vita Easyshade V spectrophotometer. The primary response variable is the clinical status of the carious lesion (active vs. arrested) measured at 3 and 6 months. Secondary outcome measures include pre- and post-treatment tooth color changes, parent-reported quality of life via the Early Childhood Oral Health Impact Scale (ECOHIS), child satisfaction regarding taste (using the TASTY scale at baseline) and tooth appearance, parent treatment acceptability, investigator ease-of-use feedback at study closeout, and documentation of adverse events including soft tissue staining or localized pain.

Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)

This study will evaluate the clinical performance of glass ionomer cervical restorations placed using the Silver-Modified Atraumatic Restorative Technique (SMART) compared with conventional restorative treatment in elderly cancer patients with cervical carious lesions. The trial is a 12-month randomized clinical trial with two parallel arms and a 1:1 allocation ratio. SMART arms will receive 38% silver diamine fluoride (SDF) and potassium iodide followed by high-viscosity glass ionomer cement (HVGIC) ), while the conventional arms will receive standard tooth preparation followed by HVGIC without SDF. The primary outcome is retention of the restoration, assessed using USPHS criteria. Secondary outcomes include postoperative hypersensitivity, marginal integrity, recurrent caries, average duration of treatment, anatomic form, color match, surface roughness, marginal discoloration, and patient satisfaction (VAS). Patients will be followed at baseline, 3, 6, 9and 12 months. The study aims to determine whether the minimally invasive SMART approach offers comparable clinical performance to conventional treatment while reducing chair time and discomfort in a medically vulnerable elderly cancer population.

Is Xylitol Toothpaste Effective in Preventing Tooth Decay?

The study will identify children at high caries risk and provide their parents/caregivers with evidence-based, risk-based at-home preventive measures for their infants, including daily use of xylitol or fluoride toothpaste. Infants aged 12-16 months with high caries risk will be invited to participate in the clinical trial. Each infant will be randomly allocated to one of two groups. In the test group, parents will be asked to use xylitol (25%) toothpaste to brush their toddler's teeth twice daily. Parents in the control group will be asked to use fluoride (1000ppm) toothpaste to brush their toddler's teeth twice daily. Identical oral health instruction and children's diet instruction will be given to every participant's caregivers. For each dental examination, an examiner will assess dental caries and oral hygiene status of infants using a standard charting form. Caregivers will complete a questionnaire. The infants' plaque and saliva will be collected to quantify Streptococcus mutans. Data will be collected at baseline, one-year and two-year follow-ups. The establishment of good oral health-related habits will safeguard and provide sustained benefits for the children. This study aims to provide evidence on the effectiveness of xylitol toothpaste and the risk of high fluoride toothpaste among young children. In the long term, findings from this study could provide the foundation for an effective oral health care promotion programme throughout Hong Kong and beyond. If shown to be effective, the framework could inform the development of oral health policies and promotion programmes to improve the oral health of young children.

Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars

Dental caries in primary teeth can sometimes lead to inflammation of the dental pulp, the soft tissue inside the tooth. When the pulp remains capable of healing, pulpotomy may be performed to preserve the tooth until its natural exfoliation. During this procedure, bleeding from the remaining pulp tissue must be controlled before a pulp dressing material is placed. This randomized controlled clinical trial aims to compare the clinical and radiographic success of TheraCal PT pulpotomy in primary molars when three different solutions are used to control bleeding: 2.5% sodium hypochlorite, 15% ferric sulfate, and normal saline. Children aged 4-6 years who have primary molars diagnosed with reversible pulpitis and meet the study's eligibility criteria will be enrolled. Participants will be randomly assigned to one of three groups according to the hemostatic solution used during the pulpotomy procedure. TheraCal PT will be used as the pulpotomy material in all three groups. The treated teeth will be evaluated clinically at 3, 6, 9, and 12 months and radiographically at baseline, 6 months, and 12 months. The researchers will compare the outcomes among the three groups to determine whether the choice of hemostatic solution affects the success of TheraCal PT pulpotomy in primary molars. The findings may help improve understanding of the role of different hemostatic solutions in pulpotomy treatment for primary teeth.

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.

Non-Restorative Versus Conventional Caries Treatment in Primary Teeth: A Randomized Controlled Trial

Dental caries is common in young children, and treatment of cavities in primary teeth can be challenging. Conventional treatment usually involves removal of carious tooth tissue and placement of a restoration. In young children, however, this approach may be associated with discomfort, the need for local anaesthesia, and difficulties with cooperation. Minimally invasive approaches have therefore been developed to control caries while reducing the burden of treatment. The main goal of this study is to evaluate whether minimally invasive approaches for treating cavitated carious lesions in primary molars are clinically effective and acceptable to young children. The study also examines whether the type of treatment influences children's cooperation and discomfort during dental care, oral health-related quality of life, and treatment costs. The main research questions are whether minimally invasive treatments can provide clinical outcomes comparable with conventional restorative treatment, whether children cooperate better or experience less discomfort during minimally invasive treatment, and whether the different treatment approaches have different effects on oral health-related quality of life and treatment costs. Children aged 3 to 6 years attending selected public kindergartens are invited to participate. Children who meet the study criteria undergo a dental examination and, when indicated, radiographic assessment of the carious lesion. Eligible children are then randomly assigned to one of three treatment groups. In the conventional treatment group, carious tooth tissue is removed and the tooth is restored with a filling. In the selective caries removal group, only part of the carious dentine is removed before the cavity is restored. In the non-restorative caries treatment group, or NRCT, no conventional restoration is placed; instead, the cavity is made accessible for cleaning when necessary, fluoride varnish is applied, and children and parents receive instructions on oral hygiene and diet. After treatment, children's cooperation and perceived discomfort are assessed. During follow-up visits, the researchers evaluate oral hygiene, the condition of the treated teeth, progression of caries, and possible treatment-related complications. Parents also complete questionnaires assessing the child's oral health-related quality of life. The study is designed to determine whether less invasive treatment approaches can offer a safe, effective, and child-friendly alternative to conventional restorative treatment of caries in primary teeth. The findings may contribute to future recommendations and clinical guidelines for the management of cavitated carious lesions in children.

Clinical Study 3MESPE Crowns CR15/02

This clinical study seeks to address four independent questions that are all part of the delivery of care associated with the provision of a single item of treatment; an indirect restoration (known as a 'crown') to restore and cover a damaged tooth. The provision of a crown requires a series of sequential clinical and laboratory stages stages: 1. Stage 1 - Preliminary impression. Taking a pre-operative impression of the tooth to be crowned. This will be used to enable the fabrication of the temporary crown after the tooth has been prepared. This is standard care and follows established clinical protocols. 2. Stage 2 - Preparation of the tooth. This involves cutting the tooth back to make space for the crown that will be fabricated to replace the missing structure. 3. Stage 3 - Taking an impression of the prepared tooth. From this a duplicate model will be made to fabricate the crown. To take the impression, the dentist will need to gently push the gums away from the tooth by fractions of a millimeter so that the margins of the preparation are clearly discernible. 4. Stage 4 - Provision of a temporary restoration that will provide satisfactory function for a limited period of time, until the definitive crown can be fitted. This temporary crown is designed to have a finite short-term durability and have an ease of manufacture and subsequent removal; hence the use of a specific cement that will enable this. 5. Stage 5 - Fitting of the definitive restoration. This is designed to be a durable restoration, with a mean life expectancy measured in years, but which is ultimately determined by a number of clinical, biological and patient specific parameters. Definitive restorations are fitted with cement designed to retain the crown in permanent manner.

Comparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars

The aim of the present study is to compare computerized intra-osseous injection system to the conventional inferior alveolar nerve block in primary mandibular teeth.

Er:YAG Laser for Dental Cavity Preparation

The goal of this clinical trial is to compare Er:YAG laser cavity preparation with conventional rotary instruments in adults who have permanent premolars planned for extraction as part of orthodontic treatment. The main questions the study aims to answer are: How do Er:YAG laser and conventional rotary instruments compare in the time needed for cavity preparation? Do participants experience different levels of pain with the two methods? Which cavity preparation method do participants prefer after experiencing both methods? Are there differences in cavity surface and interface characteristics and microleakage between teeth prepared with the two methods? Researchers will compare Er:YAG laser cavity preparation with conventional rotary cavity preparation using a split-mouth design. Each participant will receive both treatment methods on two different eligible permanent premolars. Participants will: Have one eligible premolar prepared with an Er:YAG laser and another eligible premolar prepared with conventional rotary instruments. Have the two procedures performed at separate visits on different days. Rate their pain after each procedure and indicate which treatment method they would prefer for future dental treatment. Have the study teeth extracted approximately 1 month later, as already planned for their orthodontic treatment. After extraction, the teeth will be examined in the laboratory to compare cavity surface and interface characteristics and microleakage between the two preparation methods.

Repair Versus Replacement of Failed Restorations in Primary Teeth

Dental caries affect approximately 573 million children globally, and the management of failed restorations is a frequent clinical issue in pediatric dentistry. Although complete replacement of restorations is traditionally the most commonly adopted approach, repair represents a minimally invasive alternative that preserves healthy dental structure and reduces the risk of pulpal complications. Studies in permanent teeth demonstrate that repair may present longevity similar to replacement; however, there is no robust evidence regarding this comparison in primary teeth. This randomized controlled clinical trial, with parallel groups and a 1:1 allocation ratio, aims to evaluate the non-inferiority of repair compared with replacement of failed restorations in primary molars, using encapsulated high-viscosity glass ionomer cement. Children aged 4 to 8 years with at least one failed restoration eligible for repair in primary molars will be included. Randomization will be stratified by number of surfaces. Teeth (n=824) will be randomly allocated to one of the groups: repair or replacement. The primary outcome will be restoration survival at 24 months. Cost-effectiveness will be evaluated as a secondary outcome. Statistical analysis will use Kaplan-Meier curves and Cox regression with shared frailty (¿=5%).

Evaluation of Efficacy of Antibacterial Activity of Licorice, Clove, and Chlorohexidine Mouthwashes on Salivary Streptococcus Mutans in a Group of Egyptian Children.

A randomized controlled trial that compares the antibacterial effectiveness of three mouthwashes-licorice, clove, and chlorhexidine-in Egyptian children aged 7-12 years. The main focus is Streptococcus mutans, one of the main bacteria associated with dental caries. The saliva samples will be collected from the children and the amount of S. mutans will be measured before and after using the assigned mouthwash. The children will be randomly divided into groups, with each group receiving one of the three mouthwashes. The bacterial counts will then be compared to determine which mouthwash is most effective at reducing salivary S. mutans. The research question is whether natural mouthwashes made from licorice or clove reduce the bacteria that cause cavities as effectively as chlorhexidine in children? The study could help determine whether licorice and clove are effective natural alternatives or adjuncts to chlorhexidine, particularly considering that chlorhexidine can have undesirable effects with prolonged use. Overall aim: Compare and evaluate the antibacterial efficacy of the three mouthwashes

Hall Technique vs Conventional Crown Restoration in Permanent Molars: Split-Mouth Trial in Children

The aim of this study is to compare the clinical and radiographic success of stainless steel crowns placed using the Hall Technique versus the conventional method in the restoration of permanent first molars in children, and to evaluate their effects on occlusal relationships, crown adaptation, and patient satisfaction. Study Outcomes The primary outcome of this study was to evaluate the clinical and radiographic success of stainless steel crowns placed on permanent first molars using the Hall Technique in comparison to the conventional crown placement method. The secondary outcomes included assessment of the marginal fit and adaptation of preformed crowns using both techniques, analysis of changes in occlusal relationships-specifically the vertical dimension of occlusion and overbite-and evaluation of patient satisfaction. Patient satisfaction was measured using a five-point Likert scale at multiple time points: immediately post-treatment, and at one, three, and six months.