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Dental Caries clinical trials

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NCT ID: NCT02877888 Completed - Dental Caries Clinical Trials

Effectiveness of Fluoride Varnish in Prevention of Dental Caries in School Children

Start date: August 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Despite the availability of free health dental service in Sri Lanka, the prevalence and severity of dental caries among 6year old school children stand at a very high level according to the results of national oral health survey in 1983/84, 94/95 and 2002/2003. Professional fluoride varnish application has become popular as variety of studies has found that it is an efficient method in reducing dental caries. The simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services, especially in young children. Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium fluoride varnish in prevention of dental caries in permanent incisors and molars in children between 6 and 7 years in a suburban setting in Sri Lanka. This will be a double-blind, randomized controlled trial. A sample of school children (6-7 years) will be randomized into varnish and control groups. All the children will receive routine caries preventive measures of oral hygiene instructions, dietary advice and professional cleaning. Children in varnish group will receive fluoride varnish professionally applied after prophylaxis every 6 months. Clinical examinations of all children will be performed at the beginning of the study and 1 year and 2 years later. All the caries at the dentinal level of both groups will be stabilized with temporary restorations at the beginning. During this period, each school will be visited four times at 6-month interval for recruitment, dental examinations, and fluoride varnish applications. Recruited children will be randomly assigned to either a treatment (5% NaF varnish) or a control group. Caries examinations will be conducted using the International Caries Detection and Assessment System (ICDAS). The cost for the dental team's school visits; cost involved in the treatment of dental caries throughout the course of the study in both groups will be evaluated and compared at the end of the study. The sample size is calculated as 160 each arm to detect 5% caries change with 80% power. Analysis The effect of intervention will be measured by number of caries prevented. New caries in the usual care and intervention group will be calculated after the completion of the study. The costs for intervention will be estimated. The costs will be estimated for the dental material, time for human resources and indirect costs.

NCT ID: NCT02873585 Completed - Dental Caries Clinical Trials

Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study

Start date: April 19, 2018
Phase: N/A
Study type: Interventional

A comparison of caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. The secondary objective is to assess participants experience with the s-IOT device.

NCT ID: NCT02868918 Completed - Deep Caries Clinical Trials

Evaluation of Biodentine Versus Glass Ionomer Cement in Treatment of Very Deep Carious Lesions

Start date: February 1, 2018
Phase: Phase 3
Study type: Interventional

The aim of this study is to compare the effect of new bioactive dentine substitute (Biodentine) versus glass ionomer cement in very deep carious lesions clinically and radiographically using digital radiography in the terms of postoperative pain and biocompatibility to the pulp.

NCT ID: NCT02858947 Completed - Dental Caries Clinical Trials

Three-Year Clinical Evaluation of Class II Posterior Composite Restorations

Start date: March 2011
Phase: N/A
Study type: Interventional

The aim of this study was to investigate the clinical effectiveness of direct resin composite restorations placed with different placement techniques (incremental or bulk) and with different flowable linings (conventional or bulk-fill flowable) used in open-sandwich technique, in endodontically treated Class II cavities (mesio-occlusal or disto-occlusal), in a randomized controlled comparison.

NCT ID: NCT02849925 Completed - Dental Caries Clinical Trials

Sealing Microcavitated Carious Lesions

SealCaries
Start date: March 2015
Phase: N/A
Study type: Interventional

This study aimed to test whether sealing microcavitated ICDAS 3 carious lesions in permanent molars may be arrested by sealing using two different types of materials; a glass ionomer and a resin sealant. A Randomized controlled clinical trial was designed. Children between 6 and 12 years old were recruited and a total of 150 ICDAS 3 lesions in first permanent molars were allocated to one of the two arms of the study. Clinical and radiographic lesion progression were the main outcome. Integrity of the material and retention were secondary outcomes. A follow up period of 24 months with check-ups at 6 and 12 months was considered.

NCT ID: NCT02809014 Completed - Dental Caries Clinical Trials

In Vivo Evaluation of an Experimental Fluoride-containing Dentifrice With Hydrocolloid

FdentifriceT
Start date: February 2016
Phase: N/A
Study type: Interventional

The literature recognizes that fluoride is the most widely used and studied means for dental remineralization. The use of fluoride toothpaste in brushing is considered more rational method for the prevention of caries. However, the current challenge of toothpaste is the substantivity, so new compounds have been introduced into these formulations. This study aims to evaluate the in vivo effect of fluoride dentifrice containing a natural product - hydrocolloid tara gum - in fluoride retention in saliva and dental plaque. A study of the clinical and laboratory type, crossover, double-blind, randomized will be held. After sample calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and filled teeth index less than 6 and residents in brazilian northeast capital will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after brushing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 4 toothpastes: 1100ppm F- with hydrocolloid; F- 550ppm with hydrocolloid; 1100ppm F- without hydrocolloid; Without fluoride with hydrocolloid. Between weeks of use, brushing will be extended washout (without fluoride and no hydrocolloid) to avoid carryover effect. inferential data analysis will be carried out, considering the amount of alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids promoted by the hydrocolloid may have important impact on Des-Re process and in the control of dental caries.

NCT ID: NCT02803528 Completed - Clinical trials for Patients With Deep Carious Lesions

Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Direct Pulp Capping

Start date: January 2015
Phase: N/A
Study type: Interventional

Comparative study between Biodentine and MTA in direct pulp capping of deeply carious teeth.

NCT ID: NCT02795728 Completed - Dental Caries Clinical Trials

Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial

Start date: February 2010
Phase: Phase 4
Study type: Interventional

Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. They were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.

NCT ID: NCT02782390 Completed - Dental Caries Clinical Trials

Efficacy of Hall Technique in Atypical Lesions on Primary Teeth

SLM2078
Start date: June 2016
Phase: N/A
Study type: Interventional

Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the same tooth. Dental practitioners have shown difficulties related to material's maintenance in such type of cavities and therefore, several treatment options have been used. However, most of them have shown a great failure percentage. A randomized clinical trial will be developed with the objective of assessing the Hall technique in comparison with the composite resin incremental technique in 364 primary molars' atypical carious lesions of children between 4 and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis by means of visual assessment and intraoral examination. Selected teeth will be randomly allocated into two groups. Teeth in the first group will be submitted to prefabricated stainless steel crowns treatment (Hall technique); and the other, to composite resin incremental technique, which will be always placed under rubber dam isolation. Lesions' clinical and radiographic follow-up will be conducted after 6 and 12 months. Treatment's efficacy will be assessed by means of four main outcomes: 1. Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression; 2. Patient-focused criteria (satisfaction, discomfort and quality of life impact); 3. cost-efficacy; and 4. Treatment-related parents', children' and operators' perception. Other variables could be further analysed as secondary outcomes, such as techniques performing time among operators, impact of the socio-economic characteristics on restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank test. Cox Regression will be used to enable the assessment of other variables' influence in the results. Significance value of 5% will be adopted for all analysis.

NCT ID: NCT02780856 Completed - Dental Caries Clinical Trials

Safety and Performance Evaluation of the Calcivis System

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

This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either sound (inactive) or unsound (active caries lesion present) according to ICDAS staging (International Caries Detection and Assessment System). Images of the tooth surface will be taken with the Calcivis System immediately before and after application of a disclosing solution containing a bioluminescent protein. Presence or absence of elevated luminescence on the images will indicate activity / inactivity of the presence or absence of active demineralisation on the tooth surfaces. The study will be deemed a success if there is 70% agreement and above between: 1. elevated luminescence and the presence of active caries as determined by the dentists, and 2. absence of luminescence and the determination of a sound tooth surface by the dentists.