TerminatedNot Applicable

Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Stopped: product no longer on market

United States77 participantsStarted 2010-11

Plain-language summary

Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.

Who can participate

Age range

19 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: * Over 18 years of age. * Have at least one decayed back tooth in need of a crown * Study tooth to be an upper or lower premolar or molar tooth/ teeth * Study tooth to be vital and asymptomatic at start of study Exclusion Criteria: * Teeth which are non vital, have had root canal treatment * Teeth which are pulp capped * Sensitive teeth * Significant untreated dental disease including periodontitis and rampant decay * Pregnant or lactating women * Patients with allergies to any of the materials to be used in the study * Unable to attend the recall appointments

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 of Crowns Via Modified United States Public Health Service (USPHS) Criteria

Timeframe: 1 year

Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.

Timeframe: 1 year

Trial details

NCT IDNCT01278862

SponsorSolventum US LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-03

Results submitted2017-11-08

View on ClinicalTrials.gov More Decay trials

Who can participate

Age range

19 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.