Eligibility Module

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: 2025-12-26 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 11:46 AM
NCT ID: NCT05070416
Eligibility Criteria: Inclusion Criteria: * Patients will be at least 18 years of age, of either gender, and of any ethnic background. * Each patient should have at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth. * Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration. * The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact. * All teeth will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient. Exclusion Criteria: * Devital or sensitive teeth * Teeth with prior endodontic treatment of any kind * Teeth with a history of direct or indirect pulp capping procedures * Patients with significant untreated dental disease to include periodontitis and/or rampant caries * Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times * Patients with a self-reported past history of allergies to the materials to be used in the study including composite resin cements or ceramic restorative materials * Patients unable to return for the recall appointments
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT05070416
Study Brief:
Protocol Section: NCT05070416