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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01521260
Eligibility Criteria:
Inclusion Criteria:
* The patient is ≥ 18 years of age
* The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to a fixed reference point on the dental implant, in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;
* The implants have been exposed to the oral environment for at least two years;
* The patient is capable of understanding and giving informed consent.
Exclusion Criteria:
* Medical and general contraindications for the surgical procedures;
* A history of local radiotherapy to the head and neck region;
* Pregnancy and lactation;
* Diabetes;
* Systemic use of antibiotics during the last 3 months;
* Long-term use of anti-inflammatory drugs;
* Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
* Active, uncontrolled periodontal pathology of the remaining dentition;
* Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 3 months;
* Use of mouthrinses;
* Bruxism;
* Implants placed in skin grafted areas;
* Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);
* Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
* Implant mobility;
* Implants at which no position can be identified where proper probing measurements can be performed;
* Previous surgical treatment of the peri-implantitis lesions;
* Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curretage).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01521260
Study Brief:
Protocol Section:
NCT01521260