An interventional study of Self-Etching Application Strategy and Enamel Etching Application Strategy in Dental Restoration Failure of Marginal Integrity, sponsored by Universidade Federal Fluminense. Active, not recruiting at 2 sites in Brazil. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Universidade Federal Fluminense · Not applicable, Interventional, and Treatment
Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups, that aims to evaluate the best application strategy when using a new Universal Adhesive system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. 50 enrolled patients will receive 200 Class V dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, which is the tested material in this study. Non-carious cervical lesions will receive the applied adhesive system in 4 different protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with Light Emission Diode (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERDry (Etch\& Rinse Dry): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin dry, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERWet (Etch\& Rinse Wet): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET. After applying the adhesive, the restorations will be made with composite resin, and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.
This is a Treatment clinical trial, randomized, controlled, parallel, double-blinded, with four groups, that aims to evaluate the best application strategy when using a new Universal Adhesive system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and recruited,following inclusion criteria and pre-established exclusion. All volunteers will be informed and sign a term of clarification and consent. All 50 enrolled patients will receive Class V dental restorations, made in four different ways, one from each experimental group, using the same universal self-etching adhesive system, which is the tested material in this study. All patients must have at only 20 teeth in function, must have at only 2 non carious cervical lesions (NCCL), in different teeth, that need restoration. Those lesions must be non carious, must be more than 1 mm deep, should have exposed dentin, and must have at only 50% of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with pumice powder and water. All cavities will be washed and dried after these procedures for optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth to be restored will be held. Non-carious cervical lesions will receive the applied adhesive system in 4 different protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with Light Emission Diode (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERDry (Etch\& Rinse Dry): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin dry, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET; Group ERWet (Etch\& Rinse Wet): 37% phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then, the adhesive will be applied according to the manufacturer's instructions, as described in group SET. After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores. To determine in which group each tooth will be enrolled, the authors will randomize the teeth.
283 studies on the registry are indexed under Dentin Sensitivity; 45 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 274 interventional studies indexed under Dentin Sensitivity.
Browse Dentin Sensitivity studies →Universidade Federal Fluminense is the lead sponsor of 72 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 teeth will receive restorations using Self-Etching Application Strategy
Other: Self-Etching Application Strategy
50 teeth will receive restorations using Enamel Etching Application Strategy
Other: Enamel Etching Application Strategy
50 teeth will receive restorations using Etch\&Rinse Dry Application Strategy, leaving dentin dry (but not overdry)
Other: Etch&Rinse Dry Application Strategy
50 teeth will receive restorations using Etch\&Rinse Wet Application Strategy, leaving dentin wet
Other: Etch&Rinse Wet Application Strategy
In Group SET, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
In Group SEE, 37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
In Group ERDry, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin dry (but not overdry) and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
In Group ERWet, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin wet and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
Restoration Loss
It will be evaluated the increase in the number of losses of dental restorations in the period of four years, verified by periodic visual clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of remaining restorations in the different groups.
Time frame: Four years
Marginal Pigmentation
It will be evaluated the increase in the number of dental restorations with marginal pigmentation in the period of four years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
Time frame: Four years
Post-Operative Hypersensitivity
It will be evaluated the increase in the number of dental restorations with dentin hypersensitivity in the period of four years, verified by periodic clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with dentin hypersensitivity in the different groups.
Time frame: Four years
Secondary Caries
It will be evaluated the increase in the number of dental restorations with secondary caries in the period of four years, verified by periodic radiographic examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with secondary caries in the different groups.
Time frame: Four years
Plan to share: No
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Universidade Federal Fluminense