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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03127228
Eligibility Criteria:
Inclusion Criteria:
* Subjects, aged 18 - 85 years
* Physical status according to the American Society of Anesthesiologists (ASA) I or II, which includes patients who are systemically healthy or suffer under mild to moderate, but well controlled systemic diseases.
* Subjects having a minimum of 1 dental implant with peri-implantitis.
* Dental implants with peri-implantitis ≥ 2 threads exposed (infrabony defect) identified on the radiograph and pocket probing depth (PPD) ≥ 5mm, with bleeding on probing (BOP) and/or suppuration (pus)
* The implants are in function for at least 6 months
* Only rough surface implant will be included in this study
Exclusion Criteria:
* Long-term use of antibiotics \> 2 weeks in the past two months
* Obvious malpositioning of the dental implants
* Subjects taking medications known to modify bone metabolism (such as bisphosphonates, corticosteroids, Hormone replacement therapy for menopausal women, parathyroid hormone, Denosumab, strontium ranelate)
* Pregnant females or those planning to become pregnant
* Subjects with a history of major diseases, oral cancer, sepsis or those having adverse outcomes to oral procedures in the past, will be excluded
* Mobility of dental implants
* History of alcoholism or drug abuse
* Current smokers
* Diseases of the immune system or any medical condition that may influence the outcome (uncontrolled diabetes (HbA1c \>8)
* Uncontrolled systemic disease or condition known to alter bone metabolism, like Osteoporosis, Osteopenia, Hyperparathyroidism, Paget's disease
Premature Exclusion Criteria:
* The researcher believes that it is not the best interest of the subject to stay in the study
* If the subject becomes ineligible to participate based on the exclusion criteria
* If the subject's medical condition requires interventions which preclude involvement in the study (radiation therapy, chemotherapy, etc)
* If the subject does not follow study related instructions
* The study is suspended or canceled.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03127228
Study Brief:
Protocol Section:
NCT03127228