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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT03160950
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult patients with age range 25 - 60 years
* Only the patients who would be requiring Single crown restoration in the permanent anterior / posterior teeth will be selected for the purpose of study. Single crowns are usually indicated in either of the following conditions
* Extensive coronal / structural broken tooth due to caries or trauma
* Teeth undergone successful endodontic therapy (no signs of failure- asymptomatic, no tenderness on percussion, healthy associated soft tissue)
* Microdonts
Teeth that require endodontic treatment shall be included in the study only after successful endodontic therapy has been completed by an experienced endodontist. The success of the endodontic therapy shall be evaluated using the standardized clinical and radiographic criteria by the endodontist.
* Broken teeth with \> ½ crown structure remaining will be selected.
* Broken teeth with \< ½ crown structure remaining will also be selected provided they can be restored with a crown after a conventional Post and core.
* Patients with good Occlusal Contact will be selected.
* Patients who would be giving the Signed Informed Consent shall only be enrolled for the study.
* Only the teeth showing mobility grade 0 and 1 as per Miller's Criteria shall be selected for the purpose of study.
Exclusion Criteria:
* Patients showing signs of bruxism shall not be selected. History of bruxism and wear facets will be checked for ruling out the bruxism habit.
* Patients with severe periodontal disease, that involves all teeth or tooth indicated for crown fabrication shall not be included in the study.
* Any clinical or radiographic sig or symptom indicative of periapical or furcation involvement.
* If the tooth indicated for crown fabrication depicts a mobility grade 2 or 3 as per Miller's criteria, it shall be excluded from the study.
* History of any systemic illness, pregnancy or history of allergy to dental fillings/materials shall also be excluded.
* Teeth with fracture of crown en-masse (Ellis Class VIII) fracture or which are badly mutilated such that a very minimal or No coronal structure is remaining will be excluded.
* Hypoplastic / malformed teeth will not be selected for the purpose of study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
60 Years
Study:
NCT03160950
Study Brief:
Protocol Section:
NCT03160950