Status:
RECRUITING
The Adjunctive Effect of Soft Tissue Augmentation Procedures of Moderate-severe Peri-implantitis
Lead Sponsor:
Nadja Naenni
Conditions:
Peri-Implantitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 addit...
Detailed Description
The global burden of periimplantitis is expected to rise with the increasing popularity of dental implants as a replacement option. While many therapeutic interventions have been proposed, none have b...
Eligibility Criteria
Inclusion
- Age \> 18 years old (UZH, FRA) or \> 21 years old (SIN), male and female.
- 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.
- Periodontal health (including previously treated periodontitis patients with reduced but healthy periodontium)
- Good oral hygiene (full mouth plaque score \<25%)
- Adequate control of inflammation (full mouth BOP \<25%)
- Signed informed consent form
Exclusion
- Pregnant or lactating female patient at inclusion
- Allergy or objection to porcine and bovine implantable biomaterials
- Allergy to Penicillin or NSAIDs
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language/ comprehension problems, psychological disorders, dementia, etc. of the participant
- Smoking \> 15 cigarettes a day
- Active periodontal disease
Key Trial Info
Start Date :
October 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05415111
Start Date
October 31 2022
End Date
December 1 2029
Last Update
May 14 2024
Active Locations (3)
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1
Department of Oral Surgery and Implantology, Centre for Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University Frankfurt
Frankfurt, Germany
2
National Dental Centre Singapore
Singapore, Singapore
3
Clinic of Reconstructive Dentistry, Center of Dental Medicine University of Zurich
Zurich, Switzerland