Clinical Performance of Flowable Giomer Versus Nanofilled Composite in Conservative Occlusal Cavi… (NCT06097143) | Clinical Trial Compass
CompletedNot Applicable
Clinical Performance of Flowable Giomer Versus Nanofilled Composite in Conservative Occlusal Cavities
Egypt42 participantsStarted 2023-12-15
Plain-language summary
With limited evidence-based information in literature the goal of this clinical trial is to learn about Flowable Giomer and compare it to Nanofilled Flowable Composite in Conservative Occlusal Cavities. It is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new flowable giomer (Shofu™ Beautifil Injectable X, Shofu Dental Corp., Japan) and conventional resin-based nano-filled composite (Filtek™ Z350 XT 3M ESPE, USA) which will then be coated with (Shofu™ PRG Barrier Coat, Shofu Dental Corp., Japan) will have the same clinical performance as flowable resin composite as a preventative restorative restoration in permanent molars.
Who can participate
Age range
19 Years – 40 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:
* Unilateral or Bilateral small Class I carious lesions
* Patients with good oral health
* Small Class I carious lesion in occlusal pits and fissures
Exclusion Criteria:
* Existing systemic diseases
* Severe medical complications
* Allergy history concerning methacrylates
* Pregnancy
* Heavy smoking
* Evidence of severe bruxism, clenching or temporomandibular joint disorders
* Presence of existing occlusal restoration
* Periapical or pulpal pathology
* Tooth hypersensitivity
* Possible prosthodontic restoration of teeth
* Endodontically treated teeth
* Severe periodontal affection
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
Fracture and Retention of Material
Timeframe: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up