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CompletedNCT06120868Updated Nov 7, 2023

Comparative Clinical Evaluation Between a Novel Self Adhesive and Conventional Bulk-fill Composites

An interventional study of Surefil one® and Filtek One in Class II Dental Caries, sponsored by Nourhan M.Aly. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-11-07.

Sponsored by Nourhan M.Aly · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jul 2022, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Class II Dental Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Nourhan M.Aly is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Surefil one Self-adhesive bulk fill restorative (SABF)

    Other: Surefil one®

  • Active comparator
    Filtek One Bulk Fill (FOBF)

    Other: Filtek One

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.

06

What researchers measure

Primary outcomes

  1. Clinical success of the restoration

    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.

    Time frame: up to 12 months

07

Study locations

1 site
  • Faculty of Dentistry, Alexandria University
    Alexandria, 21512, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06120868
Lead sponsor
Nourhan M.Aly
Responsible party
Nourhan M.Aly (Assistant Lecturer of Dental Public Health, University of Alexandria) — Sponsor-investigator
First posted
Nov 7, 2023
Start date
Jul 10, 2022
Primary completion
Sep 1, 2023
Completion
Sep 1, 2023
Last update
Nov 7, 2023

Study contacts

Mohamed S Ellithy, BDS
principal investigator · Alexandria University
Rania R Afifi, PhD
study director · Alexandria University
Mohamed H Hussein, PhD
study chair · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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