Comparing soft tissue augmentation methods for treating peri-implantitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
  Zurich, Switzerland Recruiting
• 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

Study contacts

• Principal investigator: Nadja Naenni, Dr. — University of Zurich
• Study coordinator: Jolanta Boruta
• Email: jolanta.boruta@zzm.uzh.ch
• Phone: +41446343260

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.