NCT04261140

Brief 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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

February 4, 2020

Last Update Submit

May 4, 2020

Conditions

Keywords

High-viscosity glass ionomerbulkfill compositeflowable compositenanohybrid compositecervical lesion

Outcome Measures

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

    6 months

Study Arms (4)

High-viscosity glass ionomer

EXPERIMENTAL
Other: EQUIA Forte Fil

flowable composite

EXPERIMENTAL
Other: NexComp Flow

bulkfill composite

EXPERIMENTAL
Other: 3M Espe Bulk-fill

nanohybrid composite

EXPERIMENTAL
Other: Clearfil Majesty Esthetic

Interventions

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

High-viscosity glass ionomer

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

nanohybrid composite

Apply in 2-mm increment light cure for 20 s

flowable composite

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

bulkfill composite

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Dentistry Faculty

Rize, 53000, Turkey (Türkiye)

Location

Study Officials

  • Gül Yıldız Telatar, Dr

    Recep Tayyip Erdogan University Dentistry Faculty

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 7, 2020

Study Start

July 1, 2019

Primary Completion

July 1, 2020

Study Completion

May 1, 2021

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Data will be available within 1 years of study completion

Locations