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:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT06695559
Eligibility Criteria:
Inclusion Criteria:
* Peri-implantitis defined as periimplant bone loss ≥ 3 mm on periapical x-rays distally, mesially or both and with Probing Pocket Depth (PPD) ≥6 mm.
* Peri-implantitis as defined above on an implant that has been in function for more than 12 months prior to study start.
* Above 18 years of age.
* Eligible for treatment in an outpatient dental clinic (ie, American Society of Anesthesiologists classification I and II).
* Had full-mouth plaque scores \< 20% prior to final inclusion.
* Had at least one implant with a loading time of ≥ 12 months prior to baseline.
* Signed Informed Consent obtained prior to start.
* Psychological appropriateness
* Consent to complete all follow-up visits.
* Patients diagnosed with periodontal disease must have undergone causative treatment and be re-evaluated
Exclusion Criteria:
* Peri-implant bone loss \> 6 mm on periapical x-rays
* Cemented supraconstructions and/or screw retained supraconstructions that for technical reasons makes it impossible to access implant for clinical measurements.
* Technical complications which according to the examiners judgement has contributed to the disease state and not possible to resolve prior to final inclusion.
* Mobile implant.
* Implants previously treated for peri-implantitis with grafting materials.
* Receiving medications known to induce mucosal hyperplasia.
* Uncontrolled diabetes (HbA1c \> 7).
* Receiving systemic antibiotics \< 3 months prior to inclusion.
* Pregnant or lactating.
* Any condition or current treatment for any condition, which in the opinion of the investigator and/or consulting physician, may constitute an unwarranted risk.
* Presence of psychological characteristics, such as inappropriate attitude or motivation, which will influence treatment execution and treatment outcome.
* Unwillingness to undergo treatment.
* If, in the medical opinion of the therapist, conditions are such that dental implants are deemed failing.
* Ongoing or previous radiotherapy to the head-neck region.
* Ongoing or previous chemotherapy.
* Systemic long-term corticosteroid treatment.
* Patients medicating with warfarin products or similar
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06695559
Study Brief:
Protocol Section:
NCT06695559