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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2023-06-23

Brief Summary

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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).

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Detailed Description

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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.).

Conditions

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Non-carious Cervical Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Two blinded, experienced, and calibrated dentists (who specialized in esthetic dentistry with more than 15 years of clinical practice), will perform the clinical evaluation. Patients will be also blinded to group assignment. An inter-examiner and inter-examiner agreement of at least 85% will be necessary before beginning the evaluation

Study Groups

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Experimental group 1

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Group Type EXPERIMENTAL

Evaporation time for 25 seconds

Intervention Type PROCEDURE

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

alcohol/water-based universal adhesive

Intervention Type DEVICE

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

Experimental group 2

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Group Type EXPERIMENTAL

Evaporation time for 25 seconds

Intervention Type PROCEDURE

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

acetone-based universal adhesive

Intervention Type DEVICE

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

Control group 1

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Group Type ACTIVE_COMPARATOR

Evaporation time for 5 seconds

Intervention Type PROCEDURE

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

alcohol/water-based universal adhesive

Intervention Type DEVICE

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

Control group 2

35 non-carious cervical lesions (NCCL) will receive composite resin restorations in the selective enamel etching strategy.

Group Type ACTIVE_COMPARATOR

Evaporation time for 5 seconds

Intervention Type PROCEDURE

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

acetone-based universal adhesive

Intervention Type DEVICE

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

Interventions

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Evaporation time for 5 seconds

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

Intervention Type PROCEDURE

Evaporation time for 25 seconds

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

Intervention Type PROCEDURE

alcohol/water-based universal adhesive

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

Intervention Type DEVICE

acetone-based universal adhesive

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

Intervention Type DEVICE

Other Intervention Names

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Evaporation time of solvent for 5 seconds Evaporation time of solvent for 25 seconds alcohol/water-based adhesive acetone universal adhesive

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes