Active — Not RecruitingNot Applicable

Different Application Strategies When Using Futurabond Universal in Class V Cavities

Brazil50 participantsStarted 2016-09-03

Plain-language summary

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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory drugs in the last 30 days.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Restoration Loss

Timeframe: Four years

Trial details

NCT IDNCT03244124

SponsorUniversidade Federal Fluminense

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-05-31

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