Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique in Class I Lesions
- Conditions
- Class I Composite Restorations
- Interventions
- Procedure: Conventional resin composite Incremental Placement TechniqueProcedure: Modeling Resin Insertion Technique
- Registration Number
- NCT05801458
- Lead Sponsor
- Cairo University
- Brief Summary
Evaluation of Resin Composite Posterior Restorations Using Modeling Resin Insertion Technique versus Conventional Composite Placement Technique in Class I Lesions: Randomized Clinical Trial
- Detailed Description
Statement of the problem In a restorative procedure, an important objective is to obtain restorations with smooth surfaces. Surface roughness has a major influence on plaque accumulation, secondary caries, and gingival irritation. Further, it may directly influence wear behavior and the marginal integrity of composite restorations. A roughened surface of a resin composite restoration is also likely to be stained by exogenous sources, such as coffee, tea, or red wine, leading to the discoloration of the material.
One of the main drawbacks of sculpting composite restorations is that some materials are sticky, reducing the ease of handling and insertion of the material into the tooth cavity. Some materials readily adhere to the composite instruments; thus, limiting reestablishment of the shape and anatomical contour of the tooth. As a result, the application of lubricants on the composite instrument such as modeling liquids/resins between the layers of composite have been proposed.
Rationale Modeling resins can be directly applied between the layers using a brush or can be used as a lubricant on manual instruments. In both the aforementioned techniques, the ease of instrumentation during the placement of esthetic restorations is superior, compared to the traditional restorative techniques. Moreover, any pores or gaps on the surface of the composite placed by means of the layering technique can be easily resolved. Hence, the modeling resin facilitates the reduction of defects in the body of the restoration and aids in improving the mechanical properties.
Although these methods are widely used, a potential shortcoming is that these techniques may adversely affect the physical and surface properties of the resin composite. However, it is unknown whether different compositions of adhesives or modeling agents may affect the surface microhardness, surface roughness, and color stability of composites over time.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Participants:
- Adult Patients (25-45).
- Good oral hygiene (plaque index score 0 or 1).
- Absence of damaging habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
Teeth:
- Vital teeth with a normal appearance and morphology.
- Primary carious lesions in molar teeth.
Participants:
- Patients with bad oral hygiene.
- Patients with known allergic or adverse reaction to the tested materials.
- Any uncontrolled systemic disease, pregnant or lactating women and any patient incapable to be present at recall follow up visits.
Teeth:
- Non-vital, fractured, or cracked teeth.
- Teeth with secondary caries or in need of replacement of existing restorations.
- Defective restorations adjacent to or opposite the tooth restored in the study.
- Rampant caries, atypical extrinsic staining of teeth.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Resin Composite Incremental Placement Technique Conventional resin composite Incremental Placement Technique Conventional resin composite incremental placement technique (Tetric® N-Ceram Nano-hybrid incremental composite) Modeling Resin Insertion Technique Modeling Resin Insertion Technique Resin Composite (Tetric® N-Ceram Nano-hybrid incremental composite) / Wetting Agent (Modeling Resin, Bisco)
- Primary Outcome Measures
Name Time Method Change from baseline in Marginal Discoloration at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
- Secondary Outcome Measures
Name Time Method Change from baseline in Color Match at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (outside the acceptable range).
Change from baseline in Retention of Restoration at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to charlie (complete loss of restoration).
Change from baseline in Postoperative Sensitivity at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Marginal Integrity at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Surface Roughness at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Anatomic form (wear) at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to delta (Immediate replacement necessary).
Change from baseline in Secondary Caries at 3,6,12 & 18 months T1: 3 months • T2: 6 months • T3: 12 months • T4: 18 months Modified US Public Health Service criteria. Possible scores range from alpha (Excellent) to bravo (Caries contiguous with the restoration margin).