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CompletedNCT03415516Updated Sep 14, 2021

Clinical Comparison of Universal Adhesives in Terms of Different Application Modes on the Restoration of NCCLs

An interventional study of Gluma Universal and All Bond Universal in Tooth Wear, sponsored by Hacettepe University. Completed. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-14.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jul 2015, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this randomized, controlled, prospective clinical trial is to evaluate the performances of two different universal adhesives and an etch\&rinse adhesive in restoration of non-caries cervical lesions. Twenty patients will receive restorations. Lesions will be divided into 7 groups according to adhesive systems and application modes: GSE: Gluma Universal- self etch, GSL: Gluma Universal-selective etching, GER: Gluma Universal-etch\&rinse, ASE: All Bond Universal- self etch, ASL: All Bond Universal- selective etching, AER: All Bond Universal- etch\&rinse, SB (Control): Single Bond2+etch\&rinse. Restorations (nano-hybrid composite) will be scored with regard to retention, marginal discoloration, marginal adaptation, recurrent caries and post operative sensitivity using modified USPHS criteria after 48 months. Two examiners who is not involved in the placement of restorations will conduct the evaluations. Descriptive statistics will be performed using Chi-square tests.

02

Conditions studied

  • Tooth Wear

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03

In context

Tooth Wear

62 studies on the registry are indexed under Tooth Wear; 12 are open to participants now.

This study's enrollment of 20 is below the median of 49 across 41 interventional studies indexed under Tooth Wear.

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Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

Inclusion criteria will be as follows:

  1. being 18 years or older,
  2. having no medical or behavioral problems preventing then from attending review visits,
  3. having at least 7 tooth with NCCLs (d) having antagonist teeth.

Exclusion Criteria:

Exlusion criteria will be:

  1. poor gingival health,
  2. uncontrolled, rampant caries,
  3. bruxism,
  4. removable partial dentures,
  5. xerostomia.
05

Study design

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

Study arms

  • Experimental
    Gluma Universal, self-etch mode (GSE)

    Device: Gluma Universal

  • Experimental
    Gluma Universal, selective etching (GSL)

    Device: Gluma Universal

  • Experimental
    Gluma Universal, etch&rinse (GER)

    Device: Gluma Universal

  • Experimental
    All Bond Universal, self-etch (ASE)

    Device: All Bond Universal

  • Experimental
    All Bond Universal, selective etching (ASL)

    Device: All Bond Universal

  • Experimental
    All Bond Universal, etch&rinse (AER)

    Device: All Bond Universal

  • Experimental
    Single Bond2, etch&rinse (SBU)

    Drug: Single Bond2

Interventions

  • DeviceGluma Universal

    Adhesive systems

  • DeviceAll Bond Universal

    Adhesive systems

  • DrugSingle Bond2

    Adhesive systems

06

What researchers measure

Primary outcomes

  1. Clinical performances of different adhesives

    Two year examinations according to USPHS criteria

    Time frame: Two years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03415516
Responsible party
Dr. Fatma Dilşad Öz (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Jan 30, 2018
Start date
Jul 1, 2015
Primary completion
Nov 1, 2015
Completion
Nov 1, 2018
Last update
Sep 14, 2021

Oversight

Data monitoring committee
No
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 Sep 2021. You cannot join it, but the record below documents what was studied.

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