Clinical Study Class II on Ceram.x Universal and Prime&Bond

Launched by SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST · Dec 12, 2016

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Inclusion criteria for patient selection:
• • Patients of either gender and at least 18 years old at the start of the study (enrollment), who are seeking treatment at the dental clinic involved, will be invited to participate in the study if they are in need of at least one eligible Class II posterior restoration in a permanent molar.
• Tooth inclusion criteria:
• • Per patient, a maximum of three Class II restorations will be included. If three restorations are indicated and eligible, one of each material will be included.
• * Vital, non-symptomatic permanent teeth with Class II lesions are suitable for inclusion into the study if the following criteria are met:
• • - location: first or second molars (ADA guidelines\[1\]);
• • - restoration size: moderate: no cusp replacements;
• • - cavity size: occlusal width ≥ 1/3 of intercuspal distance (ADA guidelines\[1\]);
• • - cavity outline: preparation to include a proximal box with or without an occlusal step;
• • - box: cervical outline in enamel;
• • - occlusion: at least one opposing contact point in enamel.
• • Enrollment of patients will continue until the specified minimum number of restorations per group (N=25) and/or the minimum number of patients (N=50) have been reached.
• Exclusion Criteria:
• Exclusion criteria for patient selection:
• * The exclusion criteria (i.e. contraindications) as described in the Instructions for Use of the test, control and restorative materials apply:
• • Use with patients who have a history of severe allergic reaction methacrylate resins or any of the components; direct application to dental pulp (direct pulp capping).
• • Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155\[4\] will not be enrolled.
• Tooth exclusion criteria:
• • As a rule, the materials are not to be used in situations as specified in the Instructions for Use - Section Contraindications.
• • direct or indirect pulp-capping Furthermore, teeth with class II lesions are excluded when involved with
• • inflammation or pulpitis (pain),
• • periodontitis with probing depth \> 6 mm,
• • extraction of tooth to be expected within the next 12 months,
• • signs of strong parafunctions or erosion (exposed dentin on occlusal surface and/or wear facets \> 6 mm2)

Trial Officials