An interventional study of Device: SHOFU beautifil II LS in Non-carious Cervical Lesions, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment
To evaluated the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence cytokines in gingival fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study clinical performance of restorations and periodontal response were evaluate.
Release of components of a resin composite system containing pre-reagent vitreal particles: laboratory and patient studies. The objectives of this study was to evaluate physical and chemical properties of a methacrylate-based restorative system regarding to the release of resin components to the storage medium, to evaluate the clinical performance of composite resin restorations, considering also the evaluation of release of resin components into saliva and the presence of cytokines in gingival crevicular fluid. Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were use. For in vitro assays, adhesive and resin specimens are being preparing for assessing the monomers degree of conversion (by FTIR), sorption and solubility and release of resinous components in ethanol and Ringer solutions (through a gas chromatography and mass spectroscopy - GC-MS). In the longitudinal clinical study, patients who present a NCCL with restorative need were selecting. Prior to treatment, there will be periodontal evaluation, saliva and gingival crevicular fluid collection (controls). The lesions were restoring with the restorative system. After 10 min,7 days, 1 and 6 months, clinical performance of restorations and periodontal response were evaluate according to the criterion FDI. Additionally, in all of these evaluation periods samples of saliva and crevicular fluid are being collecting. Saliva samples will be analyze by GC-MS to identify the eventual presence of organic components derived from the restoration. The crevicular fluid samples were analyzing using ELISA for identification and quantification of interleukins.
53 studies on the registry are indexed under Uterine Cervical Diseases; 11 are open to participants now.
This study's enrollment of 10 is below the median of 48 across 40 interventional studies indexed under Uterine Cervical Diseases.
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Exclusion Criteria:
Experimental: SHOFU Beautifil II LS Restorative system FL-Bond II (self-etching adhesive system)/ Beautifil II (composite restorative)
Other: Device: SHOFU beautifil II LS
Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were used following manufacturer's instructions
FDI criteria
The evaluation of the quality of the restoration will be evaluated using the FDI criteria and will be performed by two trained examiners at baseline and follow-up visits.The criteria has score given for each property with range from 1 to 5. Clinical assessments (Esthetic properties:surface brightness, surface and marginal color, color and translucency and anatomical form, Functional properties: marginal adaptation, fracture of material and retention, and Biological Properties: postoperative hypersensitivity, recurrence of caries, tooth integrity and adjacent mucosa)
Time frame: Up to 6 months
Clinical parameters: visible plaque index (IPV)
registered presence (score 1) or absence (score 0) of bacterial plaque without the use of probe, after drying the dental surface with compressed air.
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Clinical parameters: probing depth (PS)
distance from the gingival margin to the fundus of the gingival sulcus or periodontal pocket, which will be measured by means of manual circumferential probing and measured on all the faces of the restored teeth and control;
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months;
Clinical parameters: probing bleeding (SS)
Bleeding to the Survey (SS): evaluated at the moment of PS measurement or until 30 to 60 seconds after the introduction of the probe with dichotomic values by presence (score 1) or absence (score 0)
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Clinical parameters: gingival index (GI)
evaluates the existence and severity of gingival lesions on a scale ranging from 0 to 3, where: 0: normal; 1. mild inflammation with color change, mild edema, no bleeding at probing; 2. moderate inflammation with red, shiny, swollen gingival tissue and presence of bleeding on probing; 3. severe inflammation, with great increase of color and edema, ulceration and tendency to spontaneous bleeding.
Time frame: T1:One week before of starting treatment;T2: After 10 minutes of starting treatment;T3: After 1 week of starting treatment;T4: After 30 days of starting treatment;T5:After 6 months
Plan to share: No
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Federal University of Minas Gerais