Comparison of Two Gingival Displacement Procedures (NCT02716727) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Two Gingival Displacement Procedures
United States16 participantsStarted 2016-10
Plain-language summary
Purpose: To compare the quality of impressions made with a cordless gingival displacement procedure versus impressions made with a corded technique. The devices and materials used in both procedures are FDA-approved, marketed, and will be used according to label.
Participants: Approximately sixty (60) adult patients who are treatment planned for indirect restorations (crowns) at the UNC School of Dentistry. Procedures (methods): Participants will be randomized to receive either the cordless gingival displacement procedure (Aquasil Ultra Cordless, Dentsply), or the corded technique (Ultrapak, Intradent) followed by impression with Aquasil Ultra, Dentsply. Participants will complete the Faces pain scale. Impressions will be photographed, digitally scanned, and evaluated.
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:
* Patients must be adult males or females over the age of 18.
* Patients must be able and willing to follow study procedures and instructions.
* Patients must have read, understood and signed an informed consent form.
* Patients must be in good general health.
* Patient must require one or more indirect restorations.
* Probing pocket depths around the treatment tooth/teeth must be 4mm or less.
* There must be no bleeding on probing around the treatment tooth/teeth.
* The prepared finish line must be between 0 to 1mm sub-gingival (inclusive).
Exclusion Criteria:
* Individuals who have a chronic disease with oral manifestations.
* Individuals who exhibit gross oral pathology.
* Smokers, Diabetics
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
1
Percentage of Errors in Impressions Made for Indirect Restorations
Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set
2
Mean Time Required to Make the Impression
Timeframe: Through impression completion, an average of 10-20 minutes or when impression material is completely set
3
Mean Patient Discomfort Scores
Timeframe: From start of visit until the end of the visit, approximately 3 hours