YY/T 0990-2015Clinical trial guideline for polymer-based dental restorative materials (English PDF)

2.1 General

Medical ethics and subject rights and test personnel requirements should be consistent with the relevant national laws and regulations.

2.2 Test subjects

2.2.1 Inclusion criteria

2.2.1.1 Subjects

Healthy, 18 years old to 70 years old, sex is not limited, the opening degree is normal.

2.2.1.2 Test teeth

Lesion depth to the dentin in the middle of the dental caries, pulp vitality normal, and need to meet the following conditions.

a) tooth position. molar (priority) or premolars;

b) Type. Class I or Class II;

c) hole size. occlusal surface minimum buccal tongue diameter is not less than the cheek tongue cusp spacing of 1/3; adjacent to the hole after the gingival step in the edge of the gingival crown;

d) bite. all the filling body in the repair immediately have bite contact; for the natural teeth; bite the relationship between the normal;

e) Adjacent contact. All Class II holes are in contact with adjacent teeth and are restored to contact. In the absence of the third molar, the second mill (MO) and near-far (MOD) fillings are acceptable, but far-in (DO) fillers are not incorporated;

f) No special staining of teeth.

2.2.2 Exclusion criteria

2.2.2.1 Subjects

Subjects meet the following criteria.

a) allergies or a variety of drug allergy; dental resin and other polymer-based material history of allergies;

b) patients with severe caries; severe periodontitis; poor oral hygiene; salivary gland dysfunction; temporomandibular disorders patient;

c) Severe systemic disease; Pregnancy and Intention to Pregnant women of childbearing age and lactating women, patients with mental illness, and test subjects Person who thinks that is not suitable for inclusion.