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  • Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.

    Epidural analgesia is widely used in different types of surgeries and procedures. Pregnant women in labour compromise the single largest group benefiting from epidural analgesia. During first stage of labour (dilatation of the cervix), an epidural should cover the sensory dermatomes from T10 to L1 to achieve a good pain relief. In the second stage of labour (descent of the baby through the cervical canal), pain is mediated via S2-S4 nerve roots. Accordingly, labour epidurals are commonly placed at the lower lumbar (L3-L4) interspace.1 A study was conducted by Moore et al., comparing high vs low lumbar epidural, showed that lower epidurals provide superior perineal analgesia, when used with a patient-controlled epidural analgesia (PCEA) infusion with continuous epidural infusion (CEI), but provided less pain relief early in labour. Another study, a metanalysis showed that another mode of delivery of the local anaesthetics is more effective; which is the Programmed Intermittent Epidural Boluses (PIEB) with PCEA. The incidence of breakthrough pain, the rates of local anaesthetic usage were significantly reduced, the labour duration was statistically shorter, and the maternal satisfaction score was significantly improved in the PIEB + PCEA group compared with that in the CEI + PCEA group. This is a prospective randomised study where women will be randomised to a high or low epidural catheter to determine which is superior for maternal analgesia efficacy and satisfaction. Randomised to intervention 'high epidural' or 'low epidural' groups. Within these groups there are two subgroups based on the specific lumbar vertebral level; high epidural (L 1,2 or L 2,3 levels) and low epidural (L 3,4 or L 4,5 levels).

    Phase

    N/A

    Span

    31 weeks

    Sponsor

    The Rotunda Hospital

    Dublin

    Recruiting

    Healthy Volunteers

  • Measurement and Impact of Physical Impairment in Amyotrophic Lateral Sclerosis: Use of Digital Technologies - a Precision ALS Project

    The primary aim of this study is to investigate the validity and usability of novel digital technologies in the measurement of physical impairments (speech, swallow, strength, dexterity, mobility, and respiration) in ALS and the adherence to their use over time. The technologies that will be used in the study are as follows: 1. Speech Intelligibility Test (SIT) - software that measures speech intelligibility 2. ModalityAi- an online system that collects and analyses speech samples 3. Iowa Oral Performance Instrument (IOPI) - a device that measures tongue strength and endurance 4. Grip dynamometer - a device that measures grip strength 5. Index-eTap - a novel device and an app that measure dexterity 6. GaitKeeper - an app that measures walking 7. ActiGraph - a device that measures physical activity 8. MIR Spirometer - a device and app that measure breathing 9. Telehealth in Motor Neurone Disease (TiM) - an app that measures symptoms reported by the participant (patient reported outcome measures) Usability will be measured by means of a questionnaire called the System Usability Scale (SUS) and a semi-structured interview with a researcher. The objectives of the study are to: 1. Quantify the adherence to, usability and validity of novel digital technologies in measurement of physical parameters in ALS. 2. To compare the adherence to, usability and validity of actigraphy with devices worn on the wrist and hip concurrently for remote activity measurement. 3. To compare the adherence to, usability and validity of remote spirometry conducted independently or with clinician support via video consultation. 4. To examine the ability of Index-eTap to detect meaningful change over time in people with ALS/MND. 5. To examine the impact of impairments in cognition and behaviour on the use of digital technologies. 6. To examine the utility of audio-visual recordings for multimodal analysis of speaker samples using Modality software to analyse speech, cognitive-linguistic and facial muscle movement metrics. 7. To investigate the validity of combining data from validated technologies to form a unified scale sensitive to changes in physical impairments in ALS. 8. To develop optimal methods of summarising and visualising data relating to ALS physical impairments, for researchers working in the field of ALS Participants will complete regular assessments of physical function remotely ('at-home') using novel digital technologies and will in parallel complete three researcher-led ('in-person') assessments of comparable constructs. The in-person assessments will take place either in the clinical research centre, Beaumont Hospital or during an outreach home visit by a member of the research team, based on participant preference. On recruitment to the study, baseline demographic and clinical information will be collected from the participant and their Beaumont Hospital medical record. Participants will be followed up for one year. Participants will be recruited over 18 months. The anticipated total study duration is approximately 3 years, including data analysis. In-person assessments: The researcher will administer traditional assessments (as gold standard comparison for remote measurements) and will complete assessments using novel technologies where appropriate. In-person assessments will take place at baseline, 3 months and 12 months (or at withdrawal from the study). This assessment battery will include: - Speech intelligibility/rate: assessed using Speech Intelligibility Test (SIT) software and Zoom H1 dictaphone (traditional assessment) - Tongue strength and endurance: assessed using Iowa Oral Performance Instrument (IOPI) Pro device (traditional assessment) - Hand grip strength: Analogue Jamar Hydraulic Handgrip Dynamometer (traditional assessment) - Finger dexterity: Index-eTap device (this is a prototype device which is currently only suitable for use with a researcher and will be completed in person) - Mobility: GaitKeeper (this is a research-use novel gait analysis system, which requires testing in ALS for both in-person and for remote use) - Slow Vital Capacity (SVC): assessed using Micro Medical or equivalent desktop Spirometer device (traditional assessment) - Sniff Nasal Inspiratory Pressure (SNIP): assessed using MicroRPM device (traditional assessment) - Peak Cough Flow (PCF): Analogue peak flow meter device and facemask (traditional assessment) Additionally traditional validated questionnaires and rating scales will be completed: - Bulbar function: Centre for Neurological Studies Bulbar Function Scale (CNS-BFS) - Food texture description: Functional Oral Intake Scale (FOIS) - Upper limb function: Disability of Arm, Shoulder and Hand (DASH) - Overall function: ALS Functional Rating Scale - revised (ALSFRS-r) Following the baseline assessments, participants will be provided with the technologies appropriate for their use at home and will be trained in their use. Thereafter, participants will complete 'at-home' assessments, using technologies either independently or with support via video or phone call following a defined schedule. Participants will be asked to use a minimum of 2 suitable technologies, which will be selected by the researchers based on their clinical presentation. Participants will be provided with the option to opt-out of using a technology that they feel it would be overly burdensome for them. Researchers will maintain regular contact with participants, via phone call or video call and will 'check-in' regularly regarding how they are managing with the at-home assessments. These will include: - Multimodal assessment of speech and facial movement: using the Modality online system - Tongue strength: using Iowa Oral Performance Instrument (IOPI) Trainer device - Hand grip strength: Prototype strength ergometer device (5 participants will use this novel prototype device designed in Trinity College Dublin) - Mobility: using GaitKeeper app - Activity: using ActiGraph GT9X Link device to monitor activity - Slow Vital Capacity (SVC): using Medical International Research (MIR) Spirobank Smart spirometer device. This is used with an app and will be completed every second month via video call and every second month independently by the participant guided by the app. - Peak Cough Flow (PCF): using an analogue peak flow meter device (completed independently with score entered on TiM). - Telehealth in MND (TiM) on MyPathway: a remote monitoring system where patient-reported outcome measures are completed online. This is currently in clinical use in the Beaumont Hospital clinical service. It will collect usual questionnaires and study specific questionnaires - Communication Effectiveness Index - modified (CETI-m) - Eating Assessment Tool (EAT-10) - ALSFRS-r (self-reported) Validity of the remote measures and the novel technologies will be assessed by comparing traditional assessment methods to novel methods. After using a technology at least twice, a subset of participants will be invited to complete the System Usability Scale (SUS) questionnaire and a semi-structured interview regarding their experience using the technology. Percentage adherence to the remote monitoring schedule will also be quantified. The study will operate in accordance with data protection legislation (GDPR), the declaration of Helsinki, and with Irish and EU legal and ethical requirement for cyber-protection of sensitive patient data. A data protection impact assessment (DPIA) has been completed and approved by the Beaumont Hospital and Trinity College Dublin ethics boards. Data sharing agreements are also in place for any of the relevant technologies included in the study. This study is part of a larger research program entitled Precision ALS [www.precisionals.ie]. Precision ALS is a European project which aims to collect large amounts of data about people with MND all over Europe, to make research in ALS/MND more powerful.

    Phase

    N/A

    Span

    158 weeks

    Sponsor

    University of Dublin, Trinity College

    Dublin

    Recruiting

  • A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

    Phase

    3

    Span

    193 weeks

    Sponsor

    argenx

    Dublin

    Recruiting

  • Cervical Spine Focused Treatment for Patients with Persistent Concussion Symptoms and Neck Pain

    This is a a single site pilot randomized controlled trial consisting of a total of 40 participants with concussion and neck pain, randomized to one of two groups (n=20 per group): 1. early cervical spine focused treatment combined with standard concussion care. 2. standard concussion care alone for 4 weeks, followed by delayed introduction (after 4 weeks) of cervical spine focused treatment (which is the usual care workflow at our clinical partner site.) Both groups will receive the combination of cervical spine focused treatment and standard concussion care; the only variation being the timing of the introduction of the cervical spine care. The primary endpoint will be 4 weeks from start of cervical rehabilitation intervention. The secondary would be the point of discharge. The duration of active participation in the study will be 8 weeks for the participants.

    Phase

    N/A

    Span

    14 weeks

    Sponsor

    University of Pittsburgh

    Dublin

    Recruiting

  • Supporting University Students Transition Towards Sustainable and Healthy Dietary Behaviours: A Living Lab Approach.

    The University College Dublin (UCD) Living Lab (LL) is a series of small studies designed to develop, implement, and evaluate strategies and interventions to support university students' transition towards a sustainable and healthy diet. The LL will use a participant-centred process involving established LL methodology, with stakeholders and students actively feeding into the study design. The baseline and endpoint data collection measures of the UCD PLAN'EAT LL are described in detail below, followed by an outline of a series of planned studies. The final design and outcome(s) of each will evolve as the LL progresses. Two groups will be recruited to the UCD PLAN'EAT LL: a) UCD student participants, and b) stakeholder participants, on or connected to UCD Belfield Campus. Student and Stakeholder involvement in the LL is detailed separately below. 1. Student participants The LL study will recruit up to n=500 healthy students (aged 18-30 years) attending UCD Belfield Campus, to join the UCD PLAN'EAT LL Citizen panel. Upon successful screening and completion of informed consent, participants will be invited to join the UCD PLAN'EAT LL Citizen Panel, and then complete an initial baseline data collection, as described below. Following completion of baseline data collection measures, participants within the UCD PLAN'EAT LL Citizen Panel will subsequently be invited to participate in a series of studies (Study 1-3 detailed below), which will each form a separate registration. Students will also be invited to attend sustainable and healthy diet-related events/ activities. Following baseline data collection, subsequent participation in the LL series of studies (Study 1-3) and events/ activities is optional for all participants recruited to the UCD PLAN'EAT LL Citizen Panel. PLAN'EAT LL Citizen Panel Data Collection: LL Baseline Following informed consent, all participants recruited to the UCD PLAN'EAT LL Citizen Panel will be asked to complete a demographic, health, and lifestyle questionnaire, a diet-related questionnaire, and dietary assessment. The diet-related questionnaire will examine dietary attitudes and behaviours, including barriers and enablers of sustainable and healthy food choices, nutrition knowledge, sustainable food literacy, self-efficacy, self-regulation, food neophobia, stage of change, and the self-report behavioural automaticity index. The dietary assessment will include: up to 3 online 24-hour dietary recalls (aim: 2 non-consecutive weekdays and 1 weekend day) via the web-based dietary recall tool, Foodbook24. All data will be collected using a secure online data collection platform. PLAN'EAT LL Citizen Panel Data Collection: LL Endpoint At the end of the overall LL study or when participants are completing their course of study at UCD, all participating students recruited to the PLAN'EAT LL Citizen Panel (detailed above) will be asked to complete a demographic, health, and lifestyle questionnaire, a diet-related questionnaire, and dietary assessment. The diet-related questionnaire will examine dietary attitudes and behaviours, including barriers and enablers of sustainable and healthy food choices, nutrition knowledge, sustainable food literacy, self-efficacy, self-regulation, food neophobia, stage of change, and the self-report behavioural automaticity index. The dietary assessment will include: up to 3 online 24-hour dietary recalls (aim: 2 non-consecutive weekdays and 1 weekend day) via the web-based dietary recall tool, Foodbook24. All data will be collected using a secure online data collection platform. UCD PLAN'EAT LL Citizen Panel Process Evaluation: At the end of the overarching LL study, UCD student participants will be invited to complete a study evaluation questionnaire. In addition, a subsample of UCD student participants will also be invited to participate in focus groups or one-to-one interviews at the end of the LL study to explore topics encompassing, for example, their study experience, study acceptability, factors affecting participation rates (e.g., barriers and enablers), study engagement, and suggestions for improvement. However, in line with the LL methodology, the evaluation details will be more fully articulated and confirmed as the LL study progresses. PLAN'EAT LL Citizen Panel Study 1: Behaviour-focused personalised nutrition intervention to promote sustainable and healthy diets in university students: a feasibility pilot study. The aim of Study 1 is to test the efficacy, feasibility, and acceptability of a novel, behaviour-focused personalised nutrition intervention compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy diets in university students. This study has formed a separate registration (ClinicalTrials.gov ID: NCT06631469). PLAN'EAT LL Citizen Panel Study 2: A personalised nutrition intervention with tailored behavioural support to promote sustainable and healthy diets in university students. The aim of Study 2 is to test the efficacy of a novel personalised nutrition intervention with tailored behavioural support compared to a control personalised nutrition intervention (without tailored behavioural support) for improving adherence to sustainable and healthy diets in university students. Study 2 will incorporate key insights and learnings from Study 1 (including the process evaluation from Study 1). This study will form a separate registration. PLAN'EAT LL Citizen Panel Study 3: Co-creating food environment interventions to promote sustainable and healthy diets in the university setting. The aim of Study 3 is to co-create interventions in UCD food environments with our stakeholders to promote sustainable and healthy diets on campus. This study will form a separate registration. 2. Stakeholder participants This UCD PLAN'EAT LL study will recruit n=20 stakeholders. Upon successful completion of informed consent, stakeholders will be regularly informally consulted at several time points throughout the duration of the LL study regarding their feedback and input on LL studies. Process Evaluation: At the end of the overarching LL study, stakeholders will be invited to participate in one-to-one semi-structured interviews to explore topics encompassing, for example, their study experience, study acceptability, factors affecting participation rates (e.g., barriers and enablers), study engagement, and suggestions for improvement. However, in line with the LL methodology, the evaluation details will be more fully articulated and confirmed as the LL study progresses.

    Phase

    N/A

    Span

    149 weeks

    Sponsor

    University College Dublin

    Dublin

    Recruiting

    Healthy Volunteers

  • Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification

    Investigational strategy: Calcium modification algorithm to guide coronary intervention with an High Definition Intra Vascular Ultrasound (HD IVUS) imaging guided pathway that provides a systematic approach to coronary modification. Objectives: The aim of this study is to validate a comprehensive and intravascular imaging-based calcium modification algorithm for the treatment of moderate to severely calcified coronary lesions. Study Population: Patients with coronary artery disease with evidence of moderate to severely calcified coronary arterial lesions that are planned for percutaneous intervention requiring calcium modification. Design: CYCLOPES is a prospective, multicenter, open-label, single arm trial assessing the feasibility and efficacy of an intracoronary ultrasound guided algorithm for calcium modification in patients undergoing percutaneous coronary intervention (PCI) for chronic calcific coronary artery disease. The study will enrol 500 patients who will undergo PCI with calcium modification. Participants will be enrolled prospectively in 25 sites in Ireland, Switzerland, the United Kingdom, Spain, France, Italy and Germany (7 countries). All patients will have coronary angiography (QCA) and intravascular ultrasound (IVUS) imaging with 60MHz HD IVUS of the calcified lesion at baseline. The lesion will be characterized based on calcium distribution and morphology as assessed by HD IVUS. Depending on the specific lesion characteristics, the appropriate method for calcium modification will be chosen and performed in line with the CYCLOPES calcium modification algorithm included in the study protocol. The calcific lesion will be imaged for a second time by 60MHz HD IVUS following calcium modification. The operator will then proceed, if no further lesion preparation is required, to deploy a bioabsorbable polymer Everolimus eluting stent using standard stenting techniques, post dilatation will be performed at the operator's discretion. The treated lesion will be assessed again using intravascular ultrasound following stent deployment and optimization. The primary end points will be the post stenting minimal stent area (MSA) at the site of maximum calcification relative to reference lumen area assessed with 60MHz HD IVUS and target lesion failure (TLF) at 1-year post-procedure. All HD IVUS determined endpoints will be assessed at an independent imaging core laboratory. Participants will be assessed with clinic or phone visits at hospital discharge, 1 month and 12-month time points post procedure.

    Phase

    N/A

    Span

    130 weeks

    Sponsor

    Royal College of Surgeons, Ireland

    Dublin

    Recruiting

  • Precision Diagnosis and Care for Families With Pulmonary Fibrosis in Ireland

    Phase

    N/A

    Span

    340 weeks

    Sponsor

    Royal College of Surgeons, Ireland

    Dublin

    Recruiting

  • A Study of a Potential Disease Modifying Treatment in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

    Alzheimer's disease (AD) is an age-related neurodegenerative disorder characterized by progressive decline in cognitive function and the ability to perform activities of daily living. The amyloid hypothesis of AD postulates that the accumulation of amyloid beta (Aβ) is an early and necessary event in the pathogenesis of AD. This hypothesis suggests that interventions that slow the accumulation of Aβ plaque in the brain or increase clearance of Aβ may be able to slow the progression of the AD clinical syndrome. AD occurs on a continuum from asymptomatic (preclinical) to mild cognitive impairment (MCI), and then to dementia in mild, moderate, and severe stages. Evidence from both genetic at-risk and age at-risk cohorts, such as in dominantly inherited AD (DIAD) suggests that the pathophysiological process of AD begins well more than a decade before the clinical stage now recognized as AD dementia, and that neurodegeneration is already apparent on MRI by the stage of mild cognitive impairment. Recent clinical trial data suggest that treating AD during the earlier stages could have the greatest potential benefit on the disease by slowing progression The ability to identify individuals destined to develop Alzheimer's disease (AD) with a high degree of confidence provides a unique opportunity to assess the efficacy of therapies at asymptomatic and very early stages of dementia. Families with known disease-causing mutations are extremely rare and are geographically dispersed throughout the world. Participants in this study will not yet have developed any clinical symptoms of AD; they will be "asymptomatic" carriers of mutations that cause DIAD and would be expected to perform normally on standard cognitive and functional testing. Further, most mutation carriers will have levels of AD-associated amyloid beta (Aβ) and non-Aβ biomarkers that are the same as non-carriers. Amyloid beta is a protein that accumulates in the brain of people with AD. Although we do not understand exactly what causes AD, the abnormal accumulation of amyloid beta protein in the brain is thought to play an important role in the symptoms of AD. Recent research studies indicate that amyloid beta may start building up in the brain 15 years or more before the onset of memory loss. Imaging and fluid biomarkers will be used to demonstrate that the treatment compounds have engaged their therapeutic targets. A set of cognitive measures designed to assess the very earliest and most subtle cognitive changes will be collected. The overall objectives of this study are to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an AD-causing mutation. The primary objective of Stage 1 is to determine if treatment with the study drug prevents or slows the rate of Aβ pathological disease accumulation demonstrated by Aβ PiB positron emission tomography (PET) imaging. The primary objective of Stage 2 is to evaluate the effect of early anti-amyloid treatment on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, NfL, MRI volume) compared to a control group from the DIAN Obs natural history study and the DIAN-TU-001 placebo-treated participants. Remternetug is a monoclonal antibody. The mechanism of action of remternetug is to target and remove aggregated amyloid plaque, a key pathological hallmark of AD, via microglial-mediated clearance. Remternetug has demonstrated the ability to reduce brain amyloid plaque. The remternetug arm is part of Master Protocol DIAN-TU-002 (NCT05552157)

    Phase

    2/3

    Span

    510 weeks

    Sponsor

    Washington University School of Medicine

    Dublin

    Recruiting

    Healthy Volunteers

  • ENVELOP: Wound Care Following Pilonidal Sinus Surgery

    Pilonidal sinus disease (PSD) is a chronic inflammatory condition of the skin and subcutaneous tissues arising from hair follicles in the natal cleft. The definitive aetiology of the condition is unknown, however, it is theorised that it is the result of either the obstruction and subsequent inflammation of hair follicles or secondary to hair penetrating through the skin into the subcutaneous tissue. This results in infection, abscess formation, chronic discharge and pain. PSD is a common condition affecting 26 per 10,000 population, with the prevalence reaching 1.1% in young adult males. PSD causes a significant burden on healthcare services due to high rates of recurrence and readmission following surgery, together with negative impacts on patients' quality of life and self-image. An effective management strategy for the disease is necessary to ensure that post-operative outcomes are optimised and patient-reported outcomes are satisfactory in those whose PSD requires surgery. The objective of this multicentre, national RCT is to prospectively investigate the effect of negative pressure wound therapy compared to leaving open with standard wound care on time to wound healing following surgical excision of chronic PSD.

    Phase

    N/A

    Span

    134 weeks

    Sponsor

    Royal College of Surgeons, Ireland

    Dublin

    Recruiting

  • The Effect of an Adhesive System on the Retention and Caries Prevention for Fissure Sealants in Permanent Molars

    Introduction Resin-based fissure sealants (FS) have been used as a physical barrier in pit-and-fissures with the aim to reduce biofilm accumulation and prevent the development of new caries lesions in first permanent molars. Several international guidelines recommend the use of FS for caries prevention in the paediatric population. The majority of the FS manufactures recommend the etching of the enamel surface prior to FS application in order to remove any remaining plaque debris and to increase the surface contact area by superficial demineralisation of tooth surface. Resin based-fissure sealants contain light-activated urethane dimethacrylate (UDMA) or bisphenol A-glycidyl methacrylate (Bis-GMA) resin in its composition which bonds to the etched enamel. Several clinical studies have investigated the use of an intermediate layer of adhesive system (primer and bond) in order to increase the bonding strength and increase retention of FS over time in caries free molars, however little is known on the effect on caries progression and the choice of FS protocol for treatment of enamel caries lesions. Another factor that can influence the performance of resin-based fissure sealant due to hydrophobic characteristics of the material is the presence of saliva contamination (poor moisture control) during application. Therefore, the stage of eruption, patient's behaviour and operator experience can play a major role when it comes to FS retention on tooth surfaces. The majority of clinical trials in the field had trained and experienced operators, including specialists in paediatric dentistry, which could impact the translational and external validity of their findings. More studies are needed with less experienced operators in order to evaluate the effectiveness of FS placement in different environments. Therefore, the aim of the present randomised clinical trial is to evaluate the effectiveness of resin-based fissure sealant placed by undergraduate dental students with or without an intermediate layer of adhesive system in terms of dentine caries prevention and retention over time. Methods Study Design The present study is a two-parallel arm, controlled, single-blind clinical trial. This study will be registered at Clinical Trials website and submitted to approval by the local Ethics Committee (SJH/AMNCH Joint Research Ethics Committee). Sample Size Calculation For the sample size calculation, we have considered the results of a previous study from McCafferty & O'Connell 2016 (difference of sealant retention between the groups of 13%; bonded 92% and non-bonded 79%). The sample size calculation was performed using https://www.sealedenvelope.com/ website using a significance level of 5% (alpha) and a power of 80% (1-beta). A minimum sample of 112 teeth per group was required. We increased the sample size by 40% to compensate the cluster effect (more than one tooth can be included per child) and possible loss to follow-up. The final sample required is 313 teeth. Randomisation process The randomisation unit is the tooth and more than one tooth can be included per child. The website https://www.sealedenvelope.com/simple-randomiser/v1/lists will be used for randomisation list generation, using blocks of different sizes (4, 6 and 8). Sealed, sequentially numbered, opaque envelopes will be used and opened at the time of sealant placement. Operators All sealants will be placed by undergraduate dental students during the undergraduate clinic in Paediatric Dentistry. The treatment will be supervised by an experienced dentist/clinical supervisor. Interventions Control group (FS) 1. Cotton roll isolation: cotton roll will be placed buccally and lingually/palatally to the first permanent molar to be treated. A saliva ejector will be used to remove any excess of saliva. If the cotton roll are saturared in saliva at any point of the treatment, they will need to be changed. 2. Etching of the enamel surface: 17% phosphoric acid will be applied for 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO) using the etch syringe applicator tip. 3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface. A high volume suction will be used. Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe. 4. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip. A probe will be used to ensure that the material is present in all fissures without any air bubbles. 5. Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light. 6. Check occlusion: After checking for premature contact points, if there is a need to remove a excess of material, a superfine diamond bur or a silicone finishing point can be used for adjustments. Test group (Adhesive + FS) 1. Cotton roll isolation: cotton roll will be placed buccally and lingually/palatally to the first permanent molar to be treated. A saliva ejector will be used to remove any excess of saliva. If the cotton roll are saturared in saliva at any point of the treatment, they will need to be changed. 2. Etching of the enamel surface: 17% phosphoric acid will be applied for 15 seconds over the surface to be sealed (Phosphoric etchant gel - Vococid, VOCO) using the etch syringe applicator tip. 3. Washing/drying: a 3-1 syringe will be used to rinse all etch material from the toothsurface. A high volume suction will be used. Cotton pellets will be changed to a dry ones at this stage and the surface will be dried for 5s using the air syringe. 4. Adhesive system application: the adhesive system (Futurabond, VOCO) single dose capsule will be applied over the surface to be sealed for 5 seconds using a microbrush (ative movements along the fissures to ensure bond penetration). The bond will be air thin dried for removal of solvent and excess material. The bond will be lightcured for 10s before sealant placement. 5. Sealant application: a light-curing nano-hybrid fissure sealant material (Grandio Seal; VOCO) will be applied using the applicator tip. A probe will be used to ensure that the material is present in all fissures without any air bubbles. 6. Lightcuring: The material will be lightcured for 20 seconds. The material colour will change to an opaque off white colour when exposed to light. 7. Check occlusion: After checking for premature contact points, if there is a need to remove a excess of material, a superfine diamond bur or a silicone finishing point can be used for adjustments. Clinical variables such as children's age and gender, tooth position (upper/lower), caries experience (DMFT/dmft), ICDAS score tooth surface (1/2/3), and children's behavior during the procedure (Frankl scale) will be collected. Evaluations All children will be evaluated after 12 and 24 months by independent calibrated and blind examiners for both primary (sealant retention) and secondary outcomes. The presence of dental caries lesion will evaluated according to ICDAS criteria and caries progression into dentine will be recorded. Sealant retention will be evaluated according to the scoring system proposed by Oba et al. 2009: 0 (fully retained sealant); 1 (partially retained sealant) or 2 (absent sealant).

    Phase

    N/A

    Span

    157 weeks

    Sponsor

    University of Dublin, Trinity College

    Dublin

    Recruiting

    Healthy Volunteers

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