CClinicalTrials.gg
RecruitingNCT02891967Updated Dec 27, 2024

One-year Clinical Evaluation of Bulk-fill Versus Conventional Incremental Posterior Restoration by FDI Criteria

An interventional study of bulk fill composite and Nano resin composite (K Z350 xt) in Post Dental Restoration, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Cairo University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
All
01

Study summary

restoring posterior teeth by bulk fll and nanofill composite and clinical evaluation of performance and durability of both restorations during one year follow up

Read the detailed description

The treated cavities will be divided into 2 groups, cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²) and other group of cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.

Articulation will be checked carefully with an articulating paper and occlusal adjustments will be performed using flame shaped carbide and diamond finishing burs (DENTSPLY) using water spray, restorations will be finished occlusally with finishing burs and finally polished with aluminium oxide polishing paste and a rubber cup (DENTSPLY).

02

Conditions studied

  • Post Dental Restoration
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Good oral hygiene.Patients must show no signs of orofacial pain. The presence of molar teeth requiring composite restorations for the treatment of primary carious lesions

Exclusion criteria

Exclusion Criteria:

  • Teeth with abnormal periapical anatomy or caries that will be likely to result in very deep restorations. Teeth with old restorations or severely destructed dental crowns.Tempro-mandibular joint problems involving symptomatic pain.Pregnancy or breast feeding, acute and chronic systemic diseases, immune-compromised patients
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
69 participants (estimated)

Study arms

  • Other
    Bulk full composite (3M)

    bulk fill composite in posterior class one cavities

    Other: bulk fill composite · Other: Nano resin composite (K Z350 xt)

  • Other
    Incremental packing composite resin

    Nano resin composite (K Z350 xt) restoration in class one cavities

    Other: bulk fill composite · Other: Nano resin composite (K Z350 xt)

Interventions

  • Otherbulk fill composite

    cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²)

  • OtherNano resin composite (K Z350 xt)

    cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.

06

What researchers measure

Primary outcomes

  1. clinical performance and durability of restoration

    Outcome measure is Clinical performance and durability of composite resin restoration, Device for measurement is FDI criteria , Unit of measurement is Ranking system has 5 scores for each different criterion. Either restoration is clinically excellent, or good, or sufficient, or unsatisfactory, or clinically poor.

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Mary
    Cairo, Egypt
    • Mary · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02891967
Lead sponsor
Cairo University
Responsible party
Mary Sabry Tawfik Tadros (researcher, Cairo University) — Principal investigator
First posted
Sep 8, 2016
Start date
Jan 1, 2025 (estimated)
Primary completion
Dec 3, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Dec 27, 2024

Study contacts

Mary ST Tadros, Phd
Contact
mora.dentist@hotmail.com
01223729423 ext. Maadi
Mina GA Awad, Phd
Contact
mora.doc04@gmail.com
01211958836 ext. Helwan
Mary ST Tadros, Phd
study chair · Cairo University

Oversight

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

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