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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT05275894
Eligibility Criteria:
Inclusion Criteria:
* Male or female age \> 18 years.
* Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018)
* Peri-implant bone loss \< 2/3
* History of treated periodontal diseases (Caton 2018).
* Screw retained prosthesis that can be easily unscrewed.
* Prosthesis that allows access to biofilm control by the patient, or which can be modified accordingly.
* Absence of implant mobility
Exclusion Criteria:
Systemic exclusion criteria
* Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL
* Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation)
* Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism.
* History of leukocyte dysfunction and deficiencies.
* History of neoplastic disease requiring the use of radiation or chemotherapy.
* Patients with chronic renal failure requiring dialysis.
* Patients with metabolic bone disorders such as osteoporosis treated with antiresoptive medications.
* History of uncontrolled endocrine disorders: hypothyroidism or diabetes.
* Physical handicaps that would interfere with the ability to perform adequate oral hygiene or patients unable to use daily interproximal cleaning.
* Alcoholism or drug abuse.
* History of immunodeficiency syndromes.
* Tobacco consumption (smoking more than 10 cigarettes per day)
* Conditions or circumstances, which in the opinion of the investigator, would avoid the completion of study participation, or interfere with analysis of study results, such as history of non-compliance or unreliability, or do have any additional medical condition that contraindicates non-surgical treatment
Local exclusion criteria
* Mucosal diseases such as erosive lichen planus in the area to be treated.
* History of local irradiation therapy.
* Implants with peri-implant bone loss beyond 2/3 of the implant length
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05275894
Study Brief:
Protocol Section:
NCT05275894