CompletedNot Applicable

Clinical Performance of Two Bulk-Fill Composite of Posterior Restorations

Chile142 participantsStarted 2016-04-01

Plain-language summary

To minimize the effects of polymerization shrinkage in the restorative treatment, there are new composites called Bulk- Fill which the companies has developed this composites for example Tetric N Ceram(Ivoclar-Vivadent) and Filtek ( 3M ESPE). Its decreased polymerization shrinkage and properties allow the material to be inserted in one layer being quickly than traditional composite. This clinical study is designed to compare the clinical performance of the bulk fill composite resin in Class I (one-surface posterior), II (two-surface posterior) and V (cervical-surface posterior) fillings.

Who can participate

Age range

18 Years – 60 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: * must have given written informed consent to participate in the trial * need at least three posterior restorations * must be available for the required post-operative follow-up visits * have a buccal to lingual/palatal width no greater than 1/3 the distance from buccal to lingual/palatal cusp tips * At least one occlusal and proximal contact on a natural tooth * Cavities depth \> 2 mm in cervico-occlusal Exclusion Criteria: * have severe medical complications (organ transplants, long term antibiotic or steroid treatment, cancer or immunocompromised) and disabilities who may not be able to tolerate the time required to complete the restorations * have xerostomia either by taking medications known to produce xerostomia or those with radiation induced or Sjogren's syndrome patients * chronic periodontitis * present with any systemic or local disorders that contra-indicate the dental procedures included in this study * an unstable occlusion * severe bruxing * teeth with periapical pathology or expected pulp exposures * are pregnant. * Endodontically treated teeth

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

Clinical performance restoration

Timeframe: six month, one years, two, three, four and five years

Trial details

NCT IDNCT03230604

SponsorUniversidad Nacional Andres Bello

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-24

View on ClinicalTrials.gov More Post Dental Restoration trials