Università Vita-Salute San Raffaele
Milan, Milano, 20100, Italy
NCT Number: NCT03977298
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 for peri-implantitis is effective in disease resolution. Surgical access to peri-implant lesions facilitates the removal of all granulation tissue from the defect area as well as debridement and decontamination of the exposed implant surface defect area.
Different techniques have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Milan, Milano, 20100, Italy
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 successfully treated they may lead to implant loss. Based on the available parameters that have been reported in literature non surgical therapy doesn't seem to be effective on peri-implantitis.
Therefore it is recommended to consider advanced therapies such as surgical interventions when non surgical peri-implant therapy fails to achieve significant improvements in clinical parameters. Numerous approaches have been used for implant surface decontamination during per-implant surgery, including mechanical, chemical and laser treatments. Conventional mechanical means don't seem to be effective on peri-implant diseases. In addition, the rough implant surface is a retentive factor for bacterial colonization and therefore makes implant surface difficult to debride. Another problem in maintaining implant health concerns the presence or absence of keratinised tissue around implant: if present, it seams to help the patient to maintain an optimal level of oral hygiene around implant and therefore the implant survival itself.
The aim of the present randomized controlled clinical trial is to assess the influence of keratinised tissue around implant in improving clinical parameters. In particular, implant surface will be decontaminated mechanically with titanium curettes and chemically using chlorhexidine; after this the bone defect will be filled with bio-materlal and a CTG around tissue implant will be randomized.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine
CTG will be positioned in the buccal aspect of the peri-implant tissue
Time frame: baseline, 3, 6 and 12 months after treatment
changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing
Time frame: baseline, 3, 6 and 12 months after treatment
changes in clinical attachment level, measured from CEJ to the tip of the probe
Time frame: baseline, 3, 6 and 12 months after treatment
changes in probing depth probing, measured from gingival margin to te tip of the probe
Time frame: baseline, 3, 6 and 12 months after treatment
changes in mucosal recession, measured from CEJ to gingival margin
Time frame: baseline, 3, 6 and 12 months after treatment
changes in bone level at mesial and distal aspect, measured on periapical X-ray
Looking for future studies?
Notify MeUniversità Vita-Salute San Raffaele
Other
Surgical Protocol for Peri-implantitis in Vertical Defect in Absence of Keratinised Tissue Using Chemical Decontamination With Chlorexidine and a CTG: a Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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