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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT07005167
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥21 years
2. Good general health (ASA I or II)
3. Willing and able to provide informed consent
4. Committed to follow-up appointments for 18 months
5. Root canal treated molars requiring restoration
6. Adequate remaining tooth structure:
* Minimum 2mm ferrule height
* Sufficient wall thickness (≥1.5mm)
* At least 2 remaining walls
7. Opposing natural dentition or fixed prosthesis
8. Adequate periodontal health:
* Probing depth ≤4mm
* No bleeding on probing
9. Good oral hygiene with plaque score ≤20%
10. Sufficient mouth opening for clinical procedures
11. Normal occlusion and acceptable interocclusal space
Exclusion Criteria:
1. Pregnant or lactating women
2. Severe bruxism or parafunctional habits
3. Active periodontal disease
4. Active caries or inadequate oral hygiene
5. Less than 2mm ferrule height after preparation
6. Apical pathology or inadequate root canal treatment
7. Tooth mobility grade II or III
8. Known allergy to materials used
9. Uncontrolled diabetes (HbA1c \>7.0%)
10. Radiation therapy in head and neck region
11. Temporomandibular joint disorders
12. History of poor compliance with dental appointments
13. Heavy smokers (\>10 cigarettes/day)
14. Chronic use of medications affecting salivary flow
15. Unable to understand study requirements
16. Evidence of pulpal or periapical pathology
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07005167
Study Brief:
Protocol Section:
NCT07005167