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Dental Caries clinical trials

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NCT ID: NCT02730000 Completed - Dental Caries Clinical Trials

Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement

Start date: July 2016
Phase: N/A
Study type: Interventional

Given the clinical damage caused by errors commonly made during the dosage and handling of glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated ionomer has been recommended for final restorations. However, the initial cost of the encapsulated MIC is higher when compared to the material handled manually. The objective of this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV Riva Self Cure and Equia used as a restorative material in atraumatic restorations (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC, (3) assess whether the child's caries experience influences the longevity of atraumatic restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP municipality. Randomization will be performed in a stratified manner by the conditions: type of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV - Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and 18 months by two trained examiners blind to the groups (intra- and inter-rater agreement above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log-rank test. To evaluate the association between longevity and variable Cox regression test will be applied. For the cost analysis will be used analysis of variance.

NCT ID: NCT02727088 Recruiting - Clinical trials for Inflammatory Pulp Diseases Related to Carious Teeth

Pulpotomy vs Pulpectomy Outcome.

PULPSAVE
Start date: September 2016
Phase: N/A
Study type: Interventional

Epidemiological data show a significant rate of failure of endodontic treatment of 20 to 50% worldwide, probably directly related to the difficulty of the procedure. A successful pulpotomy allows the preservation of a vital radicular pulp into the root canal. The presence of a biological tissue into the root canal is definitely more efficient than a "complete" filling with an inert material. It has been shown on animal and human studies that this pulp stump in contact with the biomaterial is able to regenerate a dentinal plug, with the same architecture as physiologic dentin. Primary objective : To compare the success rates of root canal treatment (reference) and conservative treatment (pulpotomy) for treating inflamed dental pulp on permanent mature teeth. Secondary objectives : (1) To describe the clinical and biological prognostic factors of these two treatments; (2) to assess the additional value of biomarkers expression levels as a prognostic tool for clinical decision making (radical vs. conservative treatment); (3) to assess the impact of treatment on post-procedural pain. This trial aims to demonstrate the non-inferiority of conservative pulpal treatment over endodontic treatment. Patients consulting in one of the seven study centers, presenting one of the indications retained for the trial and giving written informed consent will receive the treatment (endodontic treatment or conservative treatment) allocated by randomization (stratified over the clinical diagnosis of the pulp status). The follow up of patients include, a phone call at D15, and visit at 1, 6, 12 and 14 post operative months. Clinical examination and Xrays at 6, 12 and 24 months) will be used to evaluate the success or failure of the treatment. During the treatment, a sample of pulp tissue will be withdrawn and transferred to a molecular biology laboratory for analysis of inflammation biomarkers. The aim of this part of the sudy is to assess a putative relationship (1) of regulation of biomarkers expression and clinical diagnosis, and (2) of regulation of these biomarkers and success rate of pulpotomy. Success/failure evaluation: The primary endpoint is the time to necessity of endodontic reintervention (analysed as a time to failure). This study will use an Intention To Treat analysis as its main assessment ; a secondary assessment accounting for peroperative conversions will assess the practical impact of these conversions. We will distinguish - Direct failure (means that the failure is directly correlated to the treatment) : the reintervention need is due to the evolution of the treated tooth. This includes delayed onset of desmodontitis, periodontal space enlargement and/or periapical/periradicular radiolucency (PAI>2) demonstrating an infection of the root canal system (filled by either pulpal stump or filling material). - Indirect failure (means that the cause of the failure is not directly related to the endodontic treatment choice) : any event leading to endodontic reintervention indication NOT caused by radicular infection or restoration failure attributable to inadequate restoration. For example : new need of post-placement for treatment of loss of another tooth, unexpected progression of periodontal disease. Both these failure modes are of interest for analysis : the direct failure time is an indication if the intrinsic value of a therapy, whereas the gross (direct+indirect) failure time is an indication of its clinical relevance (a good therapy applicable in rare cases may be less interesting than a mediocre but widely applicable one). Statistical analysis: The classical methods of descriptive analysis will be used to describe the raw results. In order to make inferences directly on possible clinical results, this study will be analyzed in a Bayesian framework. This study has been designed in reference with a frequentist demonstration of non-inferiority. A non-inferiority trial with first and second species error rates α and β has the same operational characteristics as a superiority (unilateral trial) of error rates alpha and beta, which in turn needs the same study size as a comparison (=bilateral) trial with error rates α and 2β. The final planned size of the trial is established as follows : - Ideal plan : a nonparametric comparison (logrank test) fulfilling these goals according to this plan needs 158 patients overall under "perfect information" assumptions (no loss to follow-up, single analysis) - Loss to follow-up : the expected loss to follow-up will cause about 22% of included patients to drop out of the study before final analysis this leads to include 194 patients overall. Sequential analysis : since we wish to be able to follow the progress of the study, and to interrupt it if the main goal is reached, we choose to use a sequential analysis. A Pocock scheme needs to increase the sample size by 16% , leading to plan to recruit 226 patients overall.

NCT ID: NCT02724592 Completed - Dental Caries Clinical Trials

Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions

Start date: February 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions. Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.

NCT ID: NCT02708160 Withdrawn - Dental Caries Clinical Trials

Assessment of Prevident Sodium Fluoride 1.1% Toothpaste Using an Intra-oral Remineralization-demineralization Model

Start date: March 2016
Phase: Phase 2
Study type: Interventional

This is a double blind, cross-over, controlled clinical trial utilizing thirty (30) adults to evaluate remineralization of early caries lesions.

NCT ID: NCT02705729 Completed - Dental Caries Clinical Trials

Clinical Performance of Posterior Glass Ionomer Restorations in Adolescents (KETAC)

Start date: August 3, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether two tooth-colored glass ionomer materials are effective for load-bearing dental fillings.

NCT ID: NCT02705456 Completed - Dental Caries Clinical Trials

Enamel Caries in Orthodontic Patients

ECOP
Start date: October 2014
Phase: N/A
Study type: Interventional

This randomized double-blind two arm controlled clinical trials evaluates the hypothesis that the regular use of a tooth paste containing microcrystalline hydroxylapatite provides a caries preventive effect in caries-susceptible individuals undergoing orthodontic therapy with fixed appliances which is comparable to the caries preventive effect provided by the regular use of a fluoridated tooth paste.

NCT ID: NCT02692625 Recruiting - Dental Caries Clinical Trials

Consumption Effect of Probiotic Products on Salivary Cariogenic Bacterial Counts in Preschool Children.

Start date: January 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of probiotic products on caries-associated salivary bacterial counts (Streptococcus mutans and Lactobacillus) and its effect on dental plaque accumulation in a group of preschool children in Saudi Arabia.

NCT ID: NCT02669979 Completed - Dental Caries Clinical Trials

Domiciliary Professional Oral Care for Dependent Elderly

Start date: January 2016
Phase: N/A
Study type: Interventional

Today's increase of dentate elderly, many of them dependent, is a challenge, both according to the personal daily oral hygiene and dentistry. This is not only an oral problem, as research findings point to strong associations between oral and general health, even mortality. These findings are especially noticeable in elderly and frail individuals. Dental care is usually performed in stationary dental clinics where the patients are transported to receive treatment. Dependent elderly dental patients may present many obstacles to traditional dental care due to cognitive limitations or dementia, mobility or transport problems. An alternative is domiciliary dental care where the dental staff performs the treatment by a home visit, in the patients daily living environment. The ability to handle personal oral hygiene is often decreased in these patients and left to overburdened nursing staff that often also lack sufficient knowledge about oral health care, why prophylactic professional oral care is especially important. This type of care can with rather simple equipments be performed as domiciliary treatment of good quality, while more advanced dental care may present restrictions in the home environment. However, in the Swedish dental system with subsidized dental care for dependent and elderly patients, there are restrictions for the number of prophylactic oral care treatments. The levels vary in different counties and regions. The rationale for this is probably tradition and economy as scientific evidence is lacking. The aim with this project is to develop domiciliary professional oral care. The researchers will compare the effect of different regimens for domiciliary prophylactic professional oral care both according to content and frequency. The overall aim is to establish relevant recommendations for domiciliary prophylactic professional oral care.

NCT ID: NCT02668874 Completed - Clinical trials for Dental Caries on Pit and Fissure Surface

A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants

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

The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

NCT ID: NCT02668809 Completed - Dental Caries Clinical Trials

Oral Hygiene Intervention Pilot Study

Start date: June 2014
Phase: N/A
Study type: Interventional

The main goals of this pilot study are to develop a nursing home-customized oral hygiene protocol, intended to be delivered primarily by dental hygienists and primary care providers, and to identify potential obstacles and barriers to overcome in designing a subsequent definitive study on the same topic.