3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars (NCT07091331) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
3D-printed Ceromer Crowns Versus Stainless Steel in Posterior Primary Molars
Mexico40 participantsStarted 2025-07-30
Plain-language summary
The aim of the study is to compare preformed metal crowns and 3D-printed ceromer crowns in primary molars of 4-9 years old children. The main questions it aims to answer are:
* How does 3D-printed ceromer crowns compare clincally to stainless steel crowns when restoring posterior molars?
* What is the level of satisfaction of the patient with both materials?
* What is the level of parental satisfaction with both materials?
Study methodology:
This study is a split-mouth clinical trial where participants will receive at least one of each materials in different quadrants of the mouth.
Who can participate
Age range
4 Years – 9 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:
* Children aged 4 to 9 years with at least 2 primary molars affected by deep occlusoproximal caries.
* Teeth may require pulp therapy (pulpotomy or pulpectomy) and be suitable for full-coverage restoration.
* Teeth must have an antagonist and be located in opposing hemiarches.
* The affected primary molars must be expected to remain in the mouth for at least 12 months.
* The child must be in general good health.
* Parents or legal guardians must sign informed consent, and the child must provide assent.
* Patient does not come to control appointment or does not want to continue research.
Exclusion Criteria:
* Children with systemic diseases or medical conditions affecting oral health.
* Uncooperative behavior (Frankl scale 3 or 4).
* Temporomandibular joint disorders or parafunctional habits (e.g., bruxism).
* Absence of antagonist or adjacent teeth in the selected quadrants.
* Children on long-term medication.
* Patient with allergy to local anesthetic, nickel or chromium.
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
Plaque index (PI) (Silness and Loe, 1964)
Timeframe: 12 months
2
Gingival Index (GI) (Loe & Silness, 1963)
Timeframe: 12 months
3
International Dental Federation (FDI) criteria used for clinical evaluation of indirect restorations