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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT03229005
Eligibility Criteria:
General inclusion criteria were:
* age\>18 years;
* good general health;
* non smokers;
* absence of systemic diseases affecting bone metabolism and wound healing; - no regular medication consumption for at least 3 months prior to treatment; - patient willing and fully capable to comply with the study protocol;
* written informed consent given.
Local inclusion criteria were:
* presence of keratinized mucosa with a minimum bucco-lingual width of 3 mm; - bone crest with at least 6 mm of width and 9 mm of height above the mandibular canal, without concomitant or previous bone augmentation procedures;
* presence of the opposing dentition.
Exclusion criteria were:
* history of head or neck radiation therapy;
* uncontrolled diabetes (HBA1c \>7.5%);
* active infections;
* immunocompromised patients (HIV infection or chemotherapy within the past 5 years);
* present or past treatment with intravenous bisphosphonates;
* patient pregnancy or lactating at any time during the study;
* poor oral hygiene and motivation;
* untreated periodontal disease;
* psychological or psychiatric problems;
* alcohol or drugs abuse;
* participating in other studies, if the present protocol could not be properly followed;
* lack of implant primary stability.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03229005
Study Brief:
Protocol Section:
NCT03229005