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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05156294
Eligibility Criteria:
Inclusion Criteria:
* Systemically healthy
* Periodontally healthy or with stable treated periodontitis and good oral hygiene (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) ≤ 15%, measured at six sites per tooth)
* Need for one or two implants in the posterior mandible (maximum of three missing teeth).
* Enough bone availability to place an implant with a minimum diameter of 3.8 mm and at least 7 mm length.
* Non-smoker or smokers \< 10 cig/day (self-reported).
* Ability to understand the study procedures and to comply with them to the entire length of the study.
Exclusion Criteria:
* Subjects with uncontrolled systemic diseases (ASA type III).
* Subjects taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
* Pregnant or lactating women.
* Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs.
* History of cancer requiring radiotherapy or chemotherapy during the last 5 years.
* Local inflammation (including untreated periodontitis)
* Severe bruxism or clenching habits.
* Any kind of bone augmentation performed on the implant site, with a healing period \<6 months
* Less than 4 mm of keratinized mucosa
* Post-extraction sites with \<12 weeks of healing
* Lack of primary implant stability assessed intrasurgically.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05156294
Study Brief:
Protocol Section:
NCT05156294