Status:
UNKNOWN
Surgical Protocol for Peri-implantitis Treatment
Lead Sponsor:
Università Vita-Salute San Raffaele
Conditions:
Peri-implantitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Peri-implant diseases are common post-restorative complications in implant rehabilitations and they occur with an incidence of 12-43%. Based on the available data in literature, the surgical therapy ...
Detailed Description
Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around implant surface characterized by bleeding on probing, probing depth and eventually bone loss; if not successful...
Eligibility Criteria
Inclusion
- presence of at least one screw-type titanium implant exhibiting bleeding and/or suppuration on probing combined with:
- PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of placement of the reconstruction)
- PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of placement of the reconstruction)
- single tooth and bridgework restorations without overhangs
- no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate adjustment),
- treated chronic periodontitis and proper periodontal maintenance care
- FMPS \< 20%
- non-smoker or light smoking status in smokers (\<10 cigarettes per day)
- implant function time ≥ 1 year.
Exclusion
- Patients with uncontrolled diabetes
- patients with osteoporosis or under bisphosphonate medication,
- pregnant or lactating women
- patients with a history of radiotherapy to the head and neck region
- hollow implants
- implant mobility
- implants at which no position could be identified where proper probing measurements could be performed;
- previous surgical treatment of the peri-implantitis lesions
Key Trial Info
Start Date :
July 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03801187
Start Date
July 2 2018
End Date
December 31 2021
Last Update
November 3 2020
Active Locations (1)
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1
Università Vita-Salute San Raffaele
Milan, Italy, 20100