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Non-carious Cervical LesionsNCT05945173

Evaluation of the Solvent Evaporation Time of Universal Adhesives in the Quality of Cervical Lesions Restorations

A study testing Evaporation time for 5 seconds, Evaporation time for 25 seconds and alcohol/water-based universal adhesive in people with Non-carious Cervical Lesions, run by Universidad de los Andes, Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study will be to evaluate the effect of prolonging solvent evaporation time on the 6- and 12-months clinical performance of two universal adhesive systems used as selective enamel etch (SEE). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Non-carious Cervical Lesions
What is being tested?
Evaporation time for 5 seconds, Evaporation time for 25 seconds and alcohol/water-based universal adhesive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChile
Study dates
30 Mar 2023to 23 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients older than 18 years.
  • Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.
  • Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.
  • At least 20 teeth in function.
  • Non-Carious Cervical Lesions with a maximum of 50% of enamel margin.

Who cannot join

  • Driving difficulties that prevent adequate oral hygiene.
  • Periodontal disease.
  • Active caries lesions on the teeth included in the research.
  • Parafunctional habits.
  • Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Mario Felipe Gutiérrez Reyes

    Santiago, Santiago Metropolitan, 7620086

Other trials in Chile

About this study

Official title: Clinical Evaluation of the Effect of the Prolonged Evaporation Time of the Solvent of Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double-blind Randomized Clinical Trial

The aim of this study will be to evaluate the effect of prolonging solvent evaporation time on the 6- and 12-months clinical performance of two universal adhesive systems used as selective enamel etch (SEE).

Methods: 140 restorations will be randomly placed in 35 subjects according to the following groups: SUP5 (Scotchbond Universal Plus evaporated for 5 s); SUP25 (Scotchbond Universal Plus evaporated for 25 s); GBU5 (Gluma Bond Universal evaporated for 5 s); GBU25 (Gluma Bond Universal evaporated for 25 s). Resin composite will be placed incrementally and light-cured. The restorations will be evaluated at baseline, after a week, 6 and 12 months using the FDI and USPHS criteria. Statistical analyses will be performed using appropriate tests (α = 0.05).

Read the detailed description

This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an alcohol- and water-based solvent universal adhesive (Scotchbond Universal Plus; 3M) in the selective enamel etching strategy with evaporation of solvent for 25 seconds. Experimental group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer) in the selective enamel etching strategy with solvent evaporation for 25 seconds. Control group 1: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an alcohol- and water-based universal solvent adhesive (Scotchbond Universal Plus; 3M), in the selective enamel etching strategy, with evaporation of solvent for 5 seconds. Control group 2: 35 non-carious cervical lesions (NCCL) will receive composite resin restorations, using an acetone-based universal solvent adhesive (Gluma Universal Bond; Kulzer), in the strategy of selective enamel etching, with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and flash-off time. All groups will be light-cured with a light-curing device (SmartLite Focus, Dentsply) with a light intensity of 855 mW/cm² for 20 seconds. Operators will restore the cervical area by applying three increments of resin (Opallis, FGM Prod. Odont.Ltda, Joinville, SC, Brazil). Each increment will light cure for 10 s at 1200 mW/cm2 (Radii Cal, SDI, Victoria, Australia). Restorations will be finished immediately with fine diamond burs (#3195F and #3195FF, KG Sorensen, Barueri, SP, Brazil) and polished with discs and polishing gums (Soflex, 3 M ESPE, St. Paul, MN, EE. UU.).

Being tested
Evaporation time for 5 seconds, Evaporation time for 25 seconds, alcohol/water-based universal adhesive, acetone-based universal adhesive
Keywords
Dental bonding, Tooth erosion, Tooth wear, Adhesive systems, Solvent
Medical subject headings
Tooth Erosion, Tooth Wear

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaporation time for 5 secondsProcedure or surgery

    Also called Evaporation time of solvent for 5 seconds

    Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 5 seconds.

  • Evaporation time for 25 secondsProcedure or surgery

    Also called Evaporation time of solvent for 25 seconds

    Composite resin restorations of non-carious cervical lesions will be performed with an adhesive with solvent evaporation for 25 seconds.

  • alcohol/water-based universal adhesiveDevice

    Also called alcohol/water-based adhesive

    Composite resin restorations of non-carious cervical lesions will be performed with an alcohol/water-based universal adhesive (Scotchbond Universal Plus; 3M).

  • acetone-based universal adhesiveDevice

    Also called acetone universal adhesive

    Composite resin restorations of non-carious cervical lesions will be performed with an acetone-based universal adhesive (Gluma Universal Bond; Kulzer).

Study groups in NCT05945173
Study groupRoleWhat they receive
Experimental group 1Experimental35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Receives: Procedure: Evaporation time for 25 seconds; Device: alcohol/water-based universal adhesive
Experimental group 2Experimental35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Receives: Procedure: Evaporation time for 25 seconds; Device: acetone-based universal adhesive
Control group 1Active comparator35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Receives: Procedure: Evaporation time for 5 seconds; Device: alcohol/water-based universal adhesive
Control group 2Active comparator35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.
Receives: Procedure: Evaporation time for 5 seconds; Device: acetone-based universal adhesive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention of restorations

    Retention measured by World Dental Federation (FDI) criteria as following:

    • VG: Clinically very good - Restoration retained, no fractures / cracks;
    • G: Clinically good - Small hairline crack;
    • SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity);
    • US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration);
    • PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).

    Measured: From date of randomization until twenty four months

Secondary outcomes (2)

  1. Marginal Adaptation of restorations

    Marginal Adaptation measured by World Dental Federation (FDI) criteria as following:

    • VG: Clinically very good - Harmonious outline, no gaps, no discoloration;
    • G: Clinically good - Small marginal fracture removable by polishing;
    • SS: Clinically sufficient/satisfactory - Several small enamel or dentin fractures;
    • US: Clinically unsatisfactory - Notable enamel or dentine wall fracture;
    • PO: Clinically poor - Filling is loose but in situ.

    Measured: From date of randomization until twenty four months

  2. Marginal Staining of restorations

    Marginal Staining measured by World Dental Federation (FDI) criteria as following:

    • VG: Clinically very good - No marginal staining;
    • G: Clinically good - Minor marginal staining, easily removable by polishing;
    • SS: Clinically sufficient/satisfactory - Moderate marginal staining, not esthetically unacceptable;
    • US: Clinically unsatisfactory - Pronounced marginal staining; major intervention necessary for improvement;
    • PO: Clinically poor - Deep marginal staining not accessible for intervention

    Measured: From date of randomization until twenty four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start30 Mar 2023
  3. Primary completion23 Jun 2023
  4. Study completion23 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a four-arm, double-blind, randomized controlled clinical trial. Experimental group 1: 35 non-carious cervical lesions (NCCL) using an alcohol- and water-based solvent universal adhesive with evaporation of solvent for 25 seconds. Experimental group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 25 seconds. Control group 1: 35 NCCL using an alcohol- and water-based universal solvent adhesive with evaporation of solvent for 5 seconds. Control group 2: 35 NCCL using an acetone-based universal solvent adhesive with solvent evaporation for 5 seconds. LCNCs will be randomized to universal adhesive usage and evaporation time.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05945173
Sponsor's protocol ID
CEC2022129
Status last verified
Jul 2023
First submitted
12 Jun 2023
Last updated
14 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Evaporation time for 5 seconds, Evaporation time for 25 seconds and alcohol/water-based universal adhesive in people with Non-carious Cervical Lesions, run by Universidad de los Andes, Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention of restorations (time frame: From date of randomization until twenty four months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05945173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.

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