Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT03764059
Eligibility Criteria:
Inclusion Criteria:
1. Male or female,18 to 70 years old (including 18 and 70 years)
2. Good health, no significant systemic disease;
3. Normal opening degree;
4. Molar (preferred) or premolar teeth
5. Cavity type with belongs to any of the following： 1) Class I, including the failed class I restoration which require to be repaired.; 2) Class II, including premolar and molar except the second molar (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally; 3) Class II cavity on the second molar when the third molar exists, and the gingival wall of cavity is above the free gingival margin coronally; 4) Class II, MO or MOD cavity on the second molar when the third molar does not exist (the failed class II restoration which require to be repaired is also included), and the gingival wall of cavity is above the free gingival margin coronally;
6. Cavity size: the buccolingual diameter of cavity is no less than the 1/3 and of the buccolingual cusp distance;
7. Occlusion with natural teeth;
8. Cavity depth: no less than 1/2 of dentin with a normal pulp status;
9. Be able to understand informed consent and to provide written inform consent ;
10. Be in good compliance with the protocol and willing to return to the site for follow up visits .
Exclusion Criteria:
1. Allergy to multiple medicines; allergy to resin or other polymer material;
2. Acute caries, severe periodontitis, salivary glands malfunction, dysfunction/disorder of TMJ (temporomandibular joint);
3. Poor oral hygiene, DMTF:18-34y \>4, 35-70y \>5;
4. Teeth with abnormal staining ;
5. Pathological abrasion (e.g. bruxism, clenching), acid corrosion, cracked-teeth and other non-caries diseases.
6. Abnormal occlusion;
7. Severe systemic or mental disorders;
8. Pregnant or intended to be pregnant (pregnant test is positive ) or breast feeding women;
9. Cavity do not meet the criteria based on the investigator's judgement;
10. Resin Composite is not an appropriate restoration for the subject
11. Pulp exposure or bottom of cavity is nearly close to the pulp;
12. Subjects who is not able to return for the one year follow-up visit because of going abroad or other reasons;
13. Subject is enrolled in other studies on investigational drug or device
14. Cannot tolerate rubber dam isolation. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03764059
Study Brief:
Protocol Section:
NCT03764059