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 @ 1:35 PM
Ignite Modification Date:
2025-12-24 @ 1:35 PM
NCT ID:
NCT04166695
Eligibility Criteria:
Inclusion Criteria:
* The patient is at least 18 years old.
* The patient has unrestricted legal capacity.
* The patient has two posterior teeth (premolars and / or molars) that are to be replaced next to each other.
* The patient is reliable and willing to take part in follow-up examinations regularly and over the entire study period (three years).
* The information about the study has been understood by the patient and the signed declaration of consent has been received.
Exclusion Criteria:
* Pregnancy and lactation
* Local and / or systemic acute and / or chronic (also in the past) general medical diseases and conditions that contradict participation in the study and / or expose the patient to a higher risk in the case of participation in the study.
* Severe bruxism diagnosed by a portable electrocardiomyography device (BruxOff) (\> 4 bruxism episodes / night)
* Reduced clinical crown height (\< 5 mm before tooth preparation)
* Limited periodontal health:
* probing depths \> 4 mm or = 4 mm and bleeding on probing,
* Furcation involvement \> I (first band of the periodontometer after Naber disappears completely)
* Degree of loosening of the abutment teeth \> Grade I (\> 1 mm horizontal mobility)
* Untreated endodontic problems of abutment teeth
* Lack of antagonistic support from fixed dentures or natural teeth
* Known allergies or intolerances to the materials used in the study
* Lack of oral hygiene
* Lack of compliance
* Planned change of residence
* Rejection of randomisation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04166695
Study Brief:
Protocol Section:
NCT04166695