Clinical Evaluation of a New Giomer Restorative System in Class V Restorations
Completed · Not applicable
Conditions studied: Non-carious Cervical Lesions
In brief
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.
Key facts
- Study ID
- NCT03153969
- Run by
- Tufts University
- People needed
- 49
- Starts
- 2017-08-28
- Expected to finish
- 2022-11-15
- Last updated by the study team
- 2022-11-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tufts University School of Dental Medicine — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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