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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT02823769
Eligibility Criteria:
Inclusion Criteria:
* Primary caries removal
* Class I \& II restorations
* No obvious untreated caries, dental health problems (regularly checked by a dentist)
* Good or moderate oral hygiene (plaque score of less than 30% in anterior region before treatment)
* No untreated periodontal disease (only DPSI 1, 2)
* Subjects had to present no active carious lesions
* Subjects had to be over the age of 18, be classified according to the American Society of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hy-giene, and be free of periodontal disease (probing depth and attachment levels within normal limits, no furcation involvement, and no mobility)
* Subjects had to agree to keep the scheduled recall appointments for data collec-tion and maintenance and plan to stay in the area for at least 3 years.
Exclusion Criteria:
* Composite or amalgam removal
* Caries extends cemento-enamel junction in Class II.
* Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score 2 or 3
* Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)
* Endodontic treatment with extensive loss of tooth tissue
* Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago
* Excluding the teeth, with opposing natural dentition (either intact or restored with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth
* Subjects who presented with severe wear facets and/or reported parafunctional activities such as clenching or nocturnal bruxism
* Subjects who were restored with a removable partial dental prosthesis (RPDP), unless the RPDP replaced the tooth that was planned to be restored in the study
* Subjects who were pregnant pregnant during the duration of the study
* Subjects who are known to be allergic to the ingredients of resin materials
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02823769
Study Brief:
Protocol Section:
NCT02823769