Status:
UNKNOWN
Resective Surgical Treatment of Peri-implantitis.
Lead Sponsor:
University of Belgrade
Collaborating Sponsors:
George Eastman Dental Hospital, Italy
Conditions:
Peri-Implantitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Surgical treatment of peri-implantitis can be regenerative or resective, depending on defect configuration. The aim of resective therapy of peri-implantitis is to reduce the severity of soft tissue in...
Detailed Description
The aim of the present multicenter randomized controlled trial is to compare a resective approach in the surgical treatment of peri-implantitis (decontamination performed with titanium brushes and ste...
Eligibility Criteria
Inclusion
- · Patients \>18 years old, able to provide consent and willing to undergo study procedures.
- Implants in function for at least 1 year.
- Patients with implant-supported partial/full jaw restorations having at least one implant diagnosed with peri-implantitis (probing pocket depth \[PPD\] ≥6mm, bleeding/suppuration on probing \[BoP/SoP+\] and marginal bone loss \>2 mm compared to a previous radiographic examination or marginal bone level \>3 mm (Berglundh et al. 2018)
- Patients with suprabony defects and intrabony defects up to 3mm in depth
- Retrievability of prosthetic reconstructions prior the surgical treatment (i.e. screw-retained restorations or cement-retained restorations which can easily be removed prior to all study visits)
- According to classification by Monje (Monje, 2019), implants presenting Class II, eventually Class IIIa and Class IIIb
- No implant mobility
- No evidence of occlusal overload
- Satisfactory oral hygiene level (FMPS\<25%) and periodontal health or localized periodontal inflammation (FMBS\<30%)
- Treated periodontal disease with adequate periodontal supportive therapy
Exclusion
- · Patients unable or unwilling to comply with study procedures and study visits.
- Pregnant or nursing women
- Local conditions that may interfere with surgical treatment (non-treated periodontal disease, acute infections, carious lesions, etc.)
- Compromised systemic health preventing the patient from attending study visits or representing a contraindication for surgical treatment
- Patients with uncontrolled systemic conditions which may affect healing (i.e. diabetes mellitus). Diabetic patients will have to document their level of metabolic control by means of HbA1c and will only be included when HbA1c\<7%.
- Patients smoking more than 5 cigarettes per day (self-reported)
- Patients taking medications known to interfere with gingival or bone metabolism (e.g. calcium channel blockers, bisphosphonates).
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04337645
Start Date
September 15 2020
End Date
December 15 2023
Last Update
June 11 2020
Active Locations (1)
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1
Iva Milinkovic
Belgrade, Serbia, 11000