Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations (NCT04306549) | Clinical Trial Compass
CompletedNot Applicable
Twenty-Four-Month Clinical Comparison of Two Bulk-Fill and Microhybrid Composite Restorations
25 participantsStarted 2016-08-03
Plain-language summary
ABSTRACT Objective The aim of this study was to evaluate the clinical performance of one microhybrid and two bulk-fill resin composites in Class II cavities for up to two years.
Materials and methods In total, 75 Class II restorations were made in 25 patients, using three restorative materials: two nanohybrid bulk-fill resin composites, Sonic Fill (SF) and x-tra fil (XF), and a microhybrid composite, Filtek Z-250 (FZ). The restorations were blindly evaluated by two examiners at baseline and at 6, 12, and 24 months, using U.S. Public Health Service (USPHS) criteria. The restoration groups for each category were compared using the Pearson chi-square test, and the Cochran Q-test was used to compare the changes across different time points within each restorative material (p \<0.05).
Who can participate
Age range
18 Years – 22 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:
* Patient in need of restoration of caries lesion (diagnosed with bitewing radiograph and clinical examination);
* teeth in need of restoration to be first or second molars or permanent premolars;
* at least three Class II restorations required in each patient and the number of restorations of each material to be equal in each patient;
* the antagonist and adjacent tooth in contact;
* pulp vitalized and free of painful symptoms; teeth involved not to have undergone direct pulp capping;
* no history of hypersensitivity in the teeth to be restored;
* permanent dentition;
* good oral health and absence of periodontal disease;
* patients not to have suffered from systemic diseases or allergies;
* absence of deleterious habits, xerostomia, and bruxism.
Exclusion Criteria:
* Fewer than 20 teeth;
* history of existing tooth sensitivity;
* known allergy to resin-based materials or any of the other materials used in this study;
* pregnancy or breastfeeding;
* chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs;
* non-vital teeth;
* abutment teeth for fixed or removable prostheses.
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.