Surgical Treatment of Peri-implantitis Using a Bone Substitute With or Without a Resorbable Collagen Membrane
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Andrea Ravida, DDS MS PhD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Successful Treatment of Peri-Implantitis1 year
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 12 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
- Successful Treatment of Peri-Implantitis2 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 24 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
- Successful Treatment of Peri-Implantitis3 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 36 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
- Successful Treatment of Peri-Implantitis4 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 48 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.
- Successful Treatment of Peri-Implantitis5 years
Composite definition of successful treatment outcome: A composite therapeutic endpoint composed of no evidence of BOP or evidence of BOP grade 1 and with no suppuration at any of four assessed sites per implant PPD ≤5 mm, and with ≥1.0 mm defect fill will be used to define a successful treatment outcome. Thickness of soft tissues will be measured with a 1.0 mm marked periodontal probe (UNC, Hu-Friedy, Chicago, IL, USA) on the top of bone crest in the center of the implant. This will ensure direct visibility of mucosal thickness during measurement. Definition of unsuccessful treatment will mean that the implant does not meet successful treatment outcome criteria or if an implant failure occurs. Implant failure will be defined as implant mobility (assessed from force applied with two hand instrument), pain, or neuropathy. These criteria will be assessed at 60 months post surgery. All subjects will be followed for 5 years and the same outcome will be assessed yearly.