Class II Dental Caries
Conditions
Brief summary
This study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class II cavities.
Interventions
OTHERSurefil one®
For Surefil one® restorations, the capsule will be activated by pressing it against a stable surface, then mixed in a capsule mixer for 10 s. The capsule tip will be inserted into the proximal box, and the material is extruded as the tip is gradually moved in a coronal direction, ensuring that the material adapts to the cavity bottom and walls.
OTHERFiltek One
Scotchbond™ Universal (SBU) will be used as an adhesive system in self-etch mode for FiltekTM One restoration. SBU will be applied actively for 20 seconds with a disposable brush tip, air-dried gently for 5 seconds to create a consistent bond thickness, then light-cured for 10 seconds. The FiltekTM One will be packed in increments up to 4 mm thick. A second layer of FiltekTM One will be applied on top of the first 4-mm layer if 4 mm is not adequate to properly restore the tooth. Each increment will be light cured for 20 seconds.
Sponsors
Nourhan M.Aly
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
a randomized controlled split-mouth study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients in need of restorative treatment on at least two class II Cavities in premolars or molars. * Presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic International Caries Detection and Assessment System (ICDAS I). * Presence of proximal caries in initial or moderate stage according to the International Caries Classification and Management System (ICCMS™). * Only posterior teeth with class II cavities that have antagonistic contact and at least one proximal contact. * Absence of parafunctional habits. * Good general health
Exclusion criteria
* Serious medical disorders * Clinical signs of bruxism, traumatic malocclusion * Pregnant or breast feeding at the time of restoration placement * Intolerance or allergy toward the applied restorative materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success of the restoration | up to 12 months | Clinical success of the restoration will be ranked according to the FDI Clinical Criteria which consider aesthetic, functional, and biological characteristics. The clinical assessment of the investigation criteria will be done by means of a five-score scale. FDI criteria scores 1, 2, and 3 are considered clinically excellent, good, and satisfactory. Score 4 indicates that the restoration is clinically unsatisfactory but repairable, however score 5 indicates that the restoration is clinically poor/failure and should be replaced. |
Countries
Egypt
Outcome results
None listed