Comparison of Bulk-Fill Composite Resins in Class II Restorations
- Conditions
- Class II Dental Caries
- Interventions
- Device: VisCalor Bulk,VOCO,GermanyDevice: Filtek One Bulk,3M,GermanyDevice: Admira Fusion x-tra,VOCO,Germany
- Registration Number
- NCT06212141
- Lead Sponsor
- Hacettepe University
- Brief Summary
The goal of this clinical trial is to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins .
Class II restorations will be performed in patients using three different restorative materials.And restorations will be evaluated using modified US Public Health Service criteria Resorations will be photograped and restorations will be evaluated for 6,12 months.
- Detailed Description
The aim of this clinical study was to evaluate the clinical performance of Class II restorations of a thermoviscous nanohybrid materials , of a bulk-fill composite resin, and of conventional nanohyribrid bulk-fill composite resins.
Methods and Materials: Class II restorations will be performed in patients using three different restorative materials: VisCalor Thermoviscous Bulk-Fill (VCB; a thermoviscous nanohybrid bulk-fill composite resin) , Admira Fusion x-tra ( AFT: a conventional nanohybrid bulk-fill composite resin) and 3M Filtek One Bulk-Fill Restprative (FOB: a conventional bulk-fill nanocomposite ) Futura Bond U adhesive will be used for both conventional bulk-fill composite resin restorations and thermoviscous bulk-fill composite resin restorations.
Criteria for inclusion of patients in the study : Healthy individuals without any systemic disease, patients who is between 18 and 60 years old, patiens who brush their teeth 2 times a day,voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.
Criteria for not inclusion of volunteers in research:Women who are pregnant or breastfeeding ,patienrs with advanced periodontial disease,patiens using a moving segmental prosthesis,patiens who have maloclusions,patiens who have bruxism,patients with known allergies to resin-based restorative materials and binding agents
The restorations will be evaluated using modified US Public Health Service criteria in terms of retention, color match, marginal discoloration, anatomic form, marginal adaptation, secondary caries, postoperative sensitivity, and surface texture. Resorations will be photograped and restorations will be evaluated for 6,12 months
.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 54
- Healthy individuals without any systemic disease
- Patients who is between 18 and 60 years old,
- Patiens who brush their teeth 2 times a day
- Voluntary individuals who have agreed to participate in the study and signed the illuminated consent form, who have been given initial periodontal treatment.
- Women who are pregnant or breastfeeding
- Patients with advanced periodontial disease
- Patiens using a moving segmental prosthesis
- Patiens who have maloclusions,
- Patiens who have bruxism,
- Patients with known allergies to resin-based restorative materials and binding agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description VisCalor Bulk VisCalor Bulk,VOCO,Germany Thermoviscous Bulkfill composite resin Warming of the material makes it flowable for the application and then sculptable immediately afterwards (thermoviscous technology) Optimal flowing to margins and undercut regions One universal and three aesthetic shades Cannula form Filtek One Bulk Filtek One Bulk,3M,Germany Conventional bulkfill compositeFocused options powered by 3M technology help you complete posterior restorations in a single bulk placement. 5 shades avaible : A1, A2, A3, B1, and C2. Excellent adaptation and sculptability for fast, easy placement. One-step placement : Tackle deep cavities with up to 5 mm depth of cure Admira Fusion x-tra Admira Fusion x-tra,VOCO,Germany Ormocer based bulkfill composite Purely ceramic-based, bulk fill restorative material Reliable curing of 4 mm layersby far the lowest polymerisation shrinkage (1.25 % by volume) and particularly low level of shrinkage stress, providing optimal marginal integrity. inert, so excellent biocompatible and extremely resistant to discolouration Easy handling, simple high-lustre polishing procedure coupled with high surface hardness guarantee first-class long-term results Universal shade with chameleon effect
- Primary Outcome Measures
Name Time Method Postoperative sensitivity From baseline to 18 month Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. . Charlie:constant sensitivity, not diminishing in intensity
Marginal Staining From baseline to 18 month Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction
Retention From baseline to 18 month Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material
Marginal Adaptation From baseline to 18 month Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by an independent clinician. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
Seconder caries From baseline to 18 month Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by an independent clinician. Scores: Alfa: No caries present. Charlie: Caries present
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hacettepe University
🇹🇷Ankara, Turkey