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Clinical Trials in Egypt / NCT07862894
Starting soon Not applicable

Ni-Ti Shape-Memory Versus Conventional Sectional Matrices Systems in Class II Composite Restorations: A Randomized Clinical Trial

NCT07862894 · tracked via the Priya Life Science Egypt tracker
Sponsor
Cairo University
Phase
Not applicable
Started
2026-11-01
Last updated
2026-10-07

Condition(s) studied

Class II Composite Restorations

Investigational drug(s) / intervention(s)

Ni-Ti Shape-Memory Sectional Matrix System

Ni-Ti Shape-Memory Sectional Matrix System: Intervention 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion 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. Exclusion Criteria: * Patients with bruxism or parafunctional habits. * Severe malocclusion interfering with proximal contacts. * Allergy to dental materials used in the study.

Primary outcome measure(s)

  • Proximal Contact Tightness — Immediately After Restoration Placement (baseline)
    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).

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry Cairo university Cairo Cairo Governorate

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07862894 on ClinicalTrials.gov ↗ ← All trials in Egypt