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 @ 1:57 PM
Ignite Modification Date:
2025-12-24 @ 1:57 PM
NCT ID:
NCT02119195
Eligibility Criteria:
Inclusion Criteria:
* Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria.
* Patients with more than 20 teeth.
* Restorations in functional occlusions with an opposing natural tooth.
* Asymptomatic restored tooth.
* At least one proximal contact area with a neighbouring tooth.
* Patients are older than 18 years.
* Patients who agreed and signed a consent form for participating in the study.
* Area out of the restoration´s failure is in good condition.
Inclusion Criteria for Positive Control group :
* Composite resins with alpha value in adaptation marginal criterial
Exclusion Criteria:
* Patients with contra-indications for regular dental treatment based on their medical history.
* Patients with xerostomia or taking medication that significantly decreased salivary flow.
* Patients with a high risk of caries.
* Patients with psychiatric or physical diseases, which interfered with oral hygiene.
* Patients with localized marginal deficiencies \> 1 mm. and/or secondary caries adjacent to composite restorations , or major defects
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02119195
Study Brief:
Protocol Section:
NCT02119195