CompletedNot Applicable

Clinical Performance of Posterior Composite Tooth Fillings in Adults

United States55 participantsStarted 2017-05-10

Plain-language summary

The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.

Who can participate

Age range

18 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: * be older than 18 years of age * have 2 back teeth with similar size tooth decay or failed fillings, that are in need of new moderate-size fillings * both study teeth must be vital (tested with cold) * both study fillings must be visible on the cheek-side of the tooth. Exclusion Criteria: * do not meet all inclusion criteria * are under active orthodontic treatment * have severe medical complications * have dry mouth * have chronic gum disease or poor oral hygiene * are unavailable for long term recall (minimum of 2 years required) * cannot tolerate the rubber dam * have an unstable tooth contacts * have severe bruxing or clenching, or are in need of jaw joint therapy * are pregnant or breastfeeding.

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

Number of participants with restoration failure of either material

Timeframe: 2 years

Trial details

NCT IDNCT03175627

SponsorLouisiana State University Health Sciences Center in New Orleans

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-31

View on ClinicalTrials.gov More Dental Caries trials

Who can participate

Age range

18 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.