Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posteri… (NCT04708223) | Clinical Trial Compass
CompletedNot Applicable
Prospective, Split-mouth, Comparative Study to Compare Clinical Outcomes of Two Different Posterior Composite
United States51 participantsStarted 2018-09-01
Plain-language summary
The objective of this 2-year split mouth comparative study, a randomized controlled study, is to determine whether the simplified placement procedure of the ultra-rapid polymerizing Tetric PowerFlow/ Tetric PowerFill with a reduced light polymerization time (3 s), yields the same clin-ical results as widely used commercially available dental composites (Tetric EvoCeram Bulk Fill, Tetric EvoFlow Bulk Fill) requiring up to 40 seconds of light polymerization time.
Who can participate
Age range
18 Years – 80 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:
* Each subject must need at least 2 restorations in a vital posterior tooth (in different quadrants)
* Restorations may be indicated for caries removal and restoration, replacement of defec-tive restorations (i.e. fractured, stained, unaesthetic), or requested replacement of un-aesthetic restorations.
* Must have given written consent to participate in the trial
* Must be available for the required follow-up visits over 2 years
* Restored teeth must have occlusal contact with opposing teeth or restored teeth
* Restoration width should be equal to or greater than 1/3 the distance from buccal to lin-gual cusp tips
* 75% of the restorations Class II (minimum) and 25% Class I
* One, two or three surfaces per restoration
* Each Class II will have at least one proximal contact
* 75% in molars (minimum) and 25% in premolars
* All restored teeth must have at least one occlusal contact in habitual closure
* Must have 20 or more teeth with evidence of bilateral posterior tooth contacts
* Teeth that require one or no cuspal build-ups
* Vital tooth
* Preoperative sensibility on the teeth to be treated at maximum 3 on visual analog scale (10 = maximum)
* Patient wishes to be treated in this clinical trial after oral information by the operator and after signing the informed patient form
Exclusion Criteria:
* Allergies to ingredients of the materials under investigation (monomers)
* Do not meet all inclusion criteria above
* Have medical complications (organ transpla…
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
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
Timeframe: Baseline
2
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
Timeframe: 6 Month
3
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
Timeframe: 12 Month
4
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity
Timeframe: 24 Month
5
Number of Teeth Analyzed According to FDI 11 - Postoperative Hypersensitivity