Clinical Evaluation of a New Giomer Restorative System in Class V Restorations (NCT03153969) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of a New Giomer Restorative System in Class V Restorations
United States49 participantsStarted 2017-08-28
Plain-language summary
The objective of this study is to evaluate the clinical effectiveness of a new composite resin (SHOFU Beautifil II LS) vs a control (3M/ESPE Filtek Supreme) for use in restoring non carious cervical lesions Class V lesions.
3M ESPE FiltekTM Supreme is one of the composite resin materials that will be used in this study (Group 1). This is a light-activated, flowable restorative composite.
Shofu Beautifil II LS (SI R21204) is a new type of filling material called a Giomer. This is the second composite that will be used in this study (Group 2) Giomer is a collective term for dental materials that will release ions, such as fluoride. Results from previous studies show that the released ions may have beneficial effects on the tooth, including strengthening the tooth.
In each participant, one tooth with a class V lesion will be randomized to group 1, and a second tooth with a class V lesion will be randomized to group 2. The restorations will be observed over 18 months to determine clinical acceptability.
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:
* 18 years or older, in general health
* Must have a minimum of 2 cervical lesions in need of restoration
* Cervical lesions must provide for a minimum of 1mm thickness of restorative material while maintaining natural tooth contour
* At least 50% of lesion must be in dentin
* Coronal margin of lesion must be in enamel
Exclusion Criteria:
* Rampant uncontrolled caries
* Systemic or local disorders that contra-indicate the dental procedures included in this study
* Evidence of xerostomia
* Evidence of severe bruxing or clenching or in need of TMJ related therapy
* Women who are pregnant or breast feeding (self-reported).
* Known allergy to resin composites or local anesthetics
* Abnormal oral soft tissue findings (e.g., open sores, lesions)
* Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome)
* Teeth with periapical pathology or exhibiting symptoms of pulpal pathology
* Teeth that are non-vital or have had root canal therapy
* Teeth that have been pulp capped
* Teeth with near exposures on pre-operative radiographs
* Hypersensitive teeth
* Teeth with a periodontal pocket of more than 4mm with bleeding on probing
* Teeth that are used as abutments for removable partial dentures
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.