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NCT ID: NCT06275581 Terminated - Tooth Wear Clinical Trials

Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population

Start date: June 14, 2017
Phase: N/A
Study type: Interventional

STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment. STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTS Primary Endpoint: 1. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.) Secondary Endpoints: 1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria) 2. Evaluation of restoration wear based on comparison of digital impressions Safety Endpoint: 1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers - regarding overall survival - regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M) - regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients. Treatment: After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration. Evaluation periods: All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria) - at baseline at day of restoration placement or up to 1 month after restoration placement - after 6 months (± 1 months) - after 1 year (± 1 months) - after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation. In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline.

NCT ID: NCT06227715 Completed - Tooth Wear Clinical Trials

Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive

Start date: April 28, 2016
Phase: N/A
Study type: Interventional

Objectives: To evaluate the 36-month clinical performance of Single Bond Universal Adhesive (SBU; 3M ESPE, Germany) in non-carious cervical lesions (NCCLs) using different modes adhesion approaches according to the FDI criteria. Material and methods: SBU Adhesive was applied in 252 NCCLs of 25 patients using different modes adhesion approaches: Self-etch (SE), selective-enamel-etching (SLE), total-etch (TE). All lesions were restored with nanohybrid resin composite. Restorations were evaluated at baseline, 6th, 12th, 18th, and 36th month using the FDI criteria. IBM SPSS Statistics for Windows, Version 24.0. program was used in the analysis. Differences between SE, SLE and TE groups were tested using Kruskal Wallis test. A value of p<0.05 was accepted as a criterion for statistical significance.

NCT ID: NCT06125132 Recruiting - Tooth Discoloration Clinical Trials

Evaluation of 2-year Clinical Performance of Two Different Single Color Universal Composite Resin Restorative Materials.

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Dentists have recently preferred to use composite materials and restorative techniques that allow the use of simplified clinical protocols in order to reduce the time the patient spends in the dentist's chair and minimize technical sensitivity. Color selection in the clinic is a very sensitive process and is affected by environmental factors and operator-related variables. This has led to the development of single-color universal composite resins that aim to facilitate color selection. These materials have a universal opacity and several Vita shades and are recommended by manufacturers to be used in a single color layer that can match different tooth colors. In recent years, monochromatic universal composites have been developed that are supposed to be compatible with all Vita Classic Scale shades from A1 to D4. Manufacturers report that single-color universal composites can be applied to teeth of all colors without using the layering technique using different color composites. Therefore, the aim of this study is to compare the clinical performance of 2 different single-color universal composite resin materials (OMNICHROMA and Zenchroma) in the restoration of non-carious cervical lesions with the control group (Filtek Z250, 3M), which is a multi-color composite resin material, using modified US Public Health Service (USPHS) and World Dental Federation (FDI) criteria.

NCT ID: NCT05925179 Not yet recruiting - Tooth Diseases Clinical Trials

Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening

SCLABP
Start date: August 1, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. The main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes. Participants will be asked to take either - 2 g of amoxicillin + clavulanate, or - placebo, one hour prior to surgery and without knowing what medicine they took. Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.

NCT ID: NCT05843513 Completed - Dental Wear Clinical Trials

Tooth Wear Monitoring Using Intraoral Scanner

Start date: January 18, 2019
Phase:
Study type: Observational

The overall objective was to evaluate the monitoring of tooth wear using the intraoral scanner. Forty-six participants were selected according to the established inclusion and exclusion criteria. Monitoring of tooth wear, evaluation of possible aetiological factors, as well as patient satisfaction with the use of the intraoral scanner were carried out.

NCT ID: NCT05791175 Not yet recruiting - Tooth Wear Clinical Trials

Stress and Tooth Structure Loss in Dental Students.

STSLDS
Start date: March 20, 2023
Phase:
Study type: Observational

The study is designed as a pilot study. The primary objective of the current study is to collect data on the expression and progression of tooth structure loss in dental students under stressful conditions and different dietary habits using intraoral scanners (IOS). Stress levels will be evaluated using Percived Stress Scale (PSS-10). Eating habits will be queried using reflux and dietary questionnaires. The data obtained will later be used in the case-control design of a multicenter study on the same topic. Conducting the pilot study will allow for a critical evaluation of the study's design, participant retention rate, and recruitment process.

NCT ID: NCT05686824 Completed - Clinical trials for Retention/Attrition of Midwives

Midwifery Retention Project

Start date: April 1, 2023
Phase:
Study type: Observational

The NHS is experiencing a significant workforce crisis across the service; with currently >130, 000 vacancies, therefore, national efforts to improve recruitment and retention are a priority. In maternity services, there are currently 2,500 WTE midwife vacancies and over three-quarters of Heads of Midwifery cite it is 'increasingly difficult' to fill these vacancies . A vital component of a sustainable workforce and safe maternity care is retaining newly qualified midwives (where attrition is currently high) and experienced midwives already working within the service. However, data repeatedly demonstrate dissatisfaction and intentions to leave the midwifery profession. Recognising the importance of retention, NSHEI allocated a one-off lump sum of £50,000 to each hospital Trust to specifically employ midwives to support retention efforts. However, to date, research has not captured contemporary midwifery attrition and retention insights with this role in place. Therefore, the purpose of this study is to capture, analyse and disseminate localised data from one NHS Trust to inform future local, regional and national retention projects. Specifically, this study aims to explore the views of midwives and student midwives at Torbay and South Devon NHS Foundation Trust regarding intentions to stay or leave either their current workplace and/or the profession. These subtle but salient differences are important as some may prefer to work elsewhere but remain in midwifery, conversely, others may be satisfied with their workplace but intend to leave the profession. We will also gather insights regarding the retention midwife role, their work to date and potential impact. We will gather the data via documentary review, a survey aimed at midwives and student midwives and 10-15 individual interviews. Using these insights, we will identify recommendations for the local, regional and national workstreams to inform future retention work.

NCT ID: NCT05637619 Recruiting - Wear, Occlusal Clinical Trials

Natural Dentition, Prosthesis and Antagonist Wear 3D Analysis

Start date: January 1, 2022
Phase:
Study type: Observational

Wear resistance is one of the most important physical properties of teeth, and wear resistance of zirconia against artificial acrylic, enamel and composite resin denture teeth has not been clearly established. Implant-supported dental restorations present a higher threshold for occlusion perception when compared to natural teeth, which can occlusal overload mechanisms or lead to wear of rehabilitation materials or the antagonist arch. In clinical conditions, however, many other factors influence the complex interaction between dental enamel and opposing substrates: patient-related factors such as dietary habits, dysfunctional occlusion, masticatory forces, and bruxism contribute to accelerated enamel loss of antagonist teeth.

NCT ID: NCT05604729 Recruiting - Bruxism Clinical Trials

The Effect on Envelope of Motion in Asymptomatic Bruxers

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.

NCT ID: NCT05431465 Recruiting - Dental Wear Clinical Trials

Wear of Vita Ambria Only Restoration Compared With IPS Emax Onlay Restoration

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The 1ry objective will be to evaluate the amount of wear of onlays restorations made from VITA AMBRIA & IPS e.max Press and their opposing natural teeth. 2. The 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the VITA AMBRIA onlays compared with IPS e.max press onlays as defined by FDI criteria.