Comparing soft tissue augmentation methods for treating peri-implantitis
The Adjunctive Effect of Soft Tissue Augmentation Procedures on the Surgical Treatment of Moderate-severe Peri-implantitis: A Randomized Controlled Clinical Trial.
This study is testing whether using a special collagen matrix or a tissue graft can help people with moderate to severe peri-implantitis heal better when combined with other treatments compared to those who don’t receive any soft tissue help.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 3 sites (Frankfurt and 2 other locations) |
| Trial ID | NCT05415111 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of soft tissue augmentation procedures, specifically using a volume stable collagen matrix or autogenous connective tissue graft, in conjunction with bone grafting and implantoplasty for patients suffering from moderate to severe peri-implantitis. The research will compare these methods against a control group receiving no soft tissue augmentation to determine their impact on the clinical resolution of the infection. The study addresses a significant gap in existing literature, as no randomized controlled trials have previously investigated the effects of soft tissue augmentation in this context. By including diverse patient populations and assessing patient-reported outcomes, the study seeks to provide comprehensive insights into the benefits of these interventions.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old diagnosed with peri-implantitis affecting at least one implant that has been functional for at least one year.
Not a fit: Patients who are pregnant, have allergies to the materials used, or have significant non-compliance issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and aesthetic results for patients with peri-implantitis.
How similar studies have performed: While similar studies have not been conducted, the approach of using soft tissue augmentation in conjunction with surgical therapy for peri-implantitis is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Frankfurt and 2 other locations
- Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt — Frankfurt, Germany (Not_yet_recruiting)
- National Dental Centre Singapore — Singapore, Singapore (Not_yet_recruiting)
- Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Nadja Naenni, Dr. — University of Zurich
- Study coordinator: Jolanta Boruta
- Email: jolanta.boruta@zzm.uzh.ch
- Phone: +41446343260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.