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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05248204
Eligibility Criteria:
Inclusion Criteria:
1. The Subject is between the ages of 18 and 70 years old at time of consent.
2. The Subject requires at least two direct composite restorations for posterior Class I or Class II carious lesions in vital teeth that are asymptomatic and with minimal mobility (\< 1 mm in the buccolingual direction).
3. Study teeth have a minimum buccolingual diameter of the occlusal surface that is at least 1/3 of the distance between the buccal and lingual cusps
4. Teeth selected for Class II restorations need to have an adjacent tooth in a position that will allow for a contact relationship to be established.
5. The Subject is able and willing to sign Informed Consent Form in English without assistance.
6. The Subject is able and willing to be available for all scheduled study visits.
7. The Subject is in good general health (ie, meets American Society of Anesthesiologists (ASA) Level I or ASA Level II classification criteria).
8. The selected teeth need to have occlusal contact with an antagonistic natural tooth.
9. The Subject has existing radiographic images of the study teeth of current and acceptable diagnostic quality obtained within the previous 12 months.
Exclusion Criteria:
1. The Subject has a history of adverse reaction to any materials used in this study.
2. The Subject is pregnant or breast feeding at the time of screening.
3. The Subject has fewer than 20 teeth.
4. The Subject is taking part in or planned to be enrolled in an evaluation of other restorative materials at any time during the study.
5. The Subject has advanced periodontal disease (ie, Grace \& Smales Mobility Index grade ≥ 2) that involve the study teeth.
6. The Subject had orthodontic appliance treatment within the previous 3 months.
7. The Subject has pronounced enamel wear facets, indicating severe, on-going bruxism.
8. The Subject has severe xerostomia.
9. The study tooth has a history of or existing, prolonged tooth hypersensitivity.
10. The study tooth is an abutment for fixed or removable prostheses.
11. The study tooth has a fracture or is visibly cracked such that it may impact the longevity of the tooth.
12. The carious lesion is stage RC5 or RC6 of the ICDAS radiographic scoring system.
13. The Subject is unable to understand study procedures or provide consent in English.
14. The Subject is an employee or student of the study investigator(s).
Intraoperative Exclusion Criteria:
1\) The Subject has pulp exposure of either study tooth during the restoration procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05248204
Study Brief:
Protocol Section:
NCT05248204