NCT05415111 The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis
| NCT ID | NCT05415111 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nadja Naenni |
| Condition | Peri-Implantitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2022-10-31 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The key objective of the study is to compare the effects of soft tissue augmentation using a volume stable collagen matrix or autogenous connective tissue graft or no soft tissue augmentation in addition to bone grafting/implantoplasty in patients who undergo surgical therapy of peri-implantitis with respect to clinical resolution of the infection.
Eligibility Criteria
Inclusion Criteria: 1. Age \> 18 years old (UZH, FRA) or \> 21 years old (SIN), male and female. 2. Diagnosed with periimplantitis of at least 1 implant in function for at least 1 year Diagnostic criteria * Presence of bleeding and/or suppuration on gentle probing. * Probing depths of ≥6 mm. * Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant. 3. Periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium) 4. Good oral hygiene (full mouth plaque score \<25%) 5. Adequate control of inflammation (full mouth BOP \<25%) 6. Signed informed consent form Exclusion Criteria: 1. Pregnant or lactating female patient at inclusion 2. Allergy or objection to porcine and bovine implantable biomaterials 3. Allergy to Penicillin or NSAIDs 4. Known or suspected non-compliance, drug or alcohol abuse 5. Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant 6. Smoking \> 15 cigarettes a day 7. Active periodontal disease
Contact & Investigator
Nadja Naenni, Dr.
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT05415111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peri-Implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05415111 currently recruiting?
Yes, NCT05415111 is actively recruiting participants. Contact the research team at jolanta.boruta@zzm.uzh.ch for enrollment information.
Where is the NCT05415111 trial being conducted?
This trial is being conducted at Frankfurt, Germany, Singapore, Singapore, Zurich, Switzerland.
Who is sponsoring the NCT05415111 clinical trial?
NCT05415111 is sponsored by Nadja Naenni. The principal investigator is Nadja Naenni, Dr. at University of Zurich. The trial plans to enroll 120 participants.