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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT03383120
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* At least one solid screw-type titanium implant diagnosed with peri-implantitis; which is defined as at least one site with probing depth ≥5mm, bleeding on probing and/or suppuration, and radiographic evidence of crater-form bone loss ≥2 threads after insertion of the final prosthetic supra-structure.
* Sound prosthetic supra-structure.
Exclusion Criteria:
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to Amoxicillin and/or Metronidazole,
* Systemic diseases that could compromise wound healing (i.e. uncontrolled diabetes mellitus, cancer, HIV or bone metabolic disorders), radiation or immunosuppressive therapy,
* Women who are pregnant or breast feeding,
* Known or suspected non-compliance, drug or alcohol abuse,
* Heavy smokers consuming \>10 cigarettes/day,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participants not willing to attend regular dental maintenance visits and follow-up evaluations,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Active periodontal disease.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03383120
Study Brief:
Protocol Section:
NCT03383120