The aim of this randomized controlled clinical trial is to evaluate and compare the clinical performance of a Ni-Ti shape-memory sectional matrix system versus a conventional sectional matrix system in Class II direct composite restorations.
The study will specifically assess the following clinical parameters:
1. Proximal contact tightness 2. Proximal contour quality 3. Fracture and retention of the restoration 4. Marginal adaptation These clinical parameters will be evaluated immediately after restoration placement and after a 1-year follow-up using standardized clinical assessment methods, including the FDI criteria, dental floss evaluation, and radiographic assessment, where applicable.
Fracture and retention, and marginal adaptation will be assessed according to predefined scoring criteria.
Adult patients (≥18 years) requiring Class II composite restorations in posterior teeth.
Good oral hygiene and periodontal health.
No systemic conditions affecting oral health.
Patients with bruxism or parafunctional habits.
Severe malocclusion interfering with proximal contacts.
Allergy to dental materials used in the study.
Parallel
Ni-Ti Shape-Memory Sectional Matrix System
DeviceIntervention 1 - Ni-Ti Shape-Memory Sectional Matrix System Quickmat-Flex ultra-thin titanium sectional matrix band combined with a Ni-Ti shape-memory separation ring for restoration of Class II posterior composite cavities. Intervention 2 - Conventional Sectional Matrix System TOR VM stainless-steel sectional matrix system combined with a conventional separation ring for restoration of Class II posterior composite cavities.
Proximal Contact Tightness
Proximal contact tightness will be evaluated according to the FDI criteria (item 8: approximal anatomical form). Clinical assessment will be performed using a dental floss test and calibrated metal blades (25-100 μm) to assess resistance at the proximal contact area. The outcome will be recorded according to the FDI grading scale (8.1-8.5), as described by Heintze et al. (2010).
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