CClinicalTrials.gg
WithdrawnNCT04261140Updated May 6, 2020

Clinical Evaluation of Four Aesthetic Restorations in Non-carious Cervical Lesions

An interventional study of EQUIA Forte Fil and Clearfil Majesty Esthetic in Noncarious Cervical Lesions, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Withdrawn at 1 site in Turkey. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-06.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
required license
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

To compare the clinical performance of high-viscosity glass ionomer, flowable composite, bulkfill composite and nanohybrid composite restorations in non-carious cervical lesions (NCCLs).

Read the detailed description

One hundred fourty NCCLs were randomised into four groups according to a split-mouth design. Clinical evaluations will be performed after 1 week, 3 months, 6 months, using FDI (World Dental Federation) criteria.

02

Conditions studied

  • Noncarious Cervical Lesions

Keywords

  • High-viscosity glass ionomer
  • bulkfill composite
  • flowable composite
  • nanohybrid composite
  • cervical lesion
03

In context

Uterine Cervical Diseases

53 studies on the registry are indexed under Uterine Cervical Diseases; 11 are open to participants now.

Browse Uterine Cervical Diseases studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 85 studies on the registry; 19 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • had at least four non-carious symmetrical cervical lesions,
  • had permanent dentition and were older than 20 years old,
  • had cervical margins in dentin

Exclusion criteria

Exclusion Criteria:

  • periodontal disease
  • pregnant or breastfeeding
  • being under orthodontic therapy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    High-viscosity glass ionomer

    Other: EQUIA Forte Fil

  • Experimental
    flowable composite

    Other: NexComp Flow

  • Experimental
    bulkfill composite

    Other: 3M Espe Bulk-fill

  • Experimental
    nanohybrid composite

    Other: Clearfil Majesty Esthetic

Interventions

  • OtherEQUIA Forte Fil

    Apply cavity conditioner (20% polyacrylic acid) 10 s on enamel and dentine, rinse Mix 10 s and apply bulk-fill Apply EQUIA coat and light cure for 20 s unit

  • OtherClearfil Majesty Esthetic

    Apply in 2-mm increment, light cure for 20 s

  • OtherNexComp Flow

    Apply in 2-mm increment light cure for 20 s

  • Other3M Espe Bulk-fill

    Apply in single increment up to 4 mm; light curing for 20 s

06

What researchers measure

Primary outcomes

  1. evaluation of restoration on cervical lesions

    According to FDI criteria (aesthetic, biological and fuctional) score 1, clinically very good; score 2, clinically good; score 3, clinically sufficient; score 4, clinically unsatisfactory; score 5, clinically poor. Scores 1-3 show clinically acceptable restoration, while scores 4 and 5 indicate failure

    Time frame: 6 months

07

Study locations

1 site
  • Recep Tayyip Erdogan University Dentistry Faculty
    Rize, 53000, Turkey
08

References and documents

Individual participant data

Plan to share: No — Data will be available within 1 years of study completion

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 May 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04261140
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Gul Yildiz Telatar (Principal Investigator, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Feb 7, 2020
Start date
Jul 2019 (estimated)
Primary completion
Jul 2020 (estimated)
Completion
May 2021 (estimated)
Last update
May 6, 2020

Study contacts

Gül Yıldız Telatar, Dr
principal investigator · Recep Tayyip Erdogan University Dentistry Faculty

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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