Dental Caries
Conditions
Keywords
self-etch adhesive, selective enamel etching, Adper Easy Bond, Supreme Ultra, Molar and premolar teeth, Adult, Class I and II cavities
Brief summary
Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.
Detailed description
There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.
Interventions
DEVICEAdper Easy Bond Self-etch dental adhesive
Bonding composite to restore Class I or Class II cavities
Sponsors
3M
Solventum US LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * written informed consent * regular dental attender, can return to clinic for study recalls * good medical health * normal saliva flow * has one or two pairs of back teeth that require a Class I or II restoration of appropriate size * study teeth that are vital
Exclusion criteria
* currently in an evaluation of other dental materials * an irregular dental attender * has unacceptable oral hygiene standards * has chronic periodontitis or rampant caries * has teeth with signs of periapical pathology * has history of pulp problems, and/or needs pulp treatment * women who are pregnant or breast-feeding * has known allergy to resin composite or latex * has serious chronic disease requiring hospitalization * has oral soft tissue pathologies * takes medications which, in the opinion of the investigator, could interfere with the conduct of the study * has current or recent history of alcohol or other substance abuse * is an employee of the sponsor or the study site, or members of their immediate family * has had any restorative treatment of teeth involved in the study in the last twelve months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of the Restoration | one year | Bonded filling still in place |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical performance of the study restoration | one year | Restoration in satisfactory clinical function at one year |
Countries
United States
Outcome results
None listed