Peri-implantitis is a infectious disease that resides in the mucosa surrounding dental implants and also affects the supporting bone. Because the number of implants placed in everyday clinical practice is continuously increasing, is it reasonable to anticipate an increasing prevalence of peri-implantitis. This underlines the necessity for a predictable therapy. However, from the literature there is very little reliable evidence suggesting which could be the most effective interventions for treating periimplantitis. The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective is to assess the microbiological effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The primary study parameter is the change from baseline in modified bleeding index. Secondary study parameters are: change in microbial composition of the biofilm covering the dental implant surface; microbiological composition of the peri-implant sulcus; change in probing pocket depth;change in suppuration on probing; change in radiographic marginal bone level on standardized intraoral radiographs; change in modified plaque index; implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection; complications and adverse events. It is hypothesized that decontamination of the implant surface with 2% chlorhexidine leads to a greater decrease in modified bleeding index than decontamination with a 0.12% chlorhexidine solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
University Medical Center Groningen
Groningen, Netherlands
Change from baseline in modified bleeding index.
Time frame: baseline, 3, 6 and 12 months after treatment
Change in microbial composition of the biofilm covering the dental implant surface
Time frame: during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure'
Microbiological composition of the peri-implant sulcus
Time frame: before treatment and 3, 6 and 12 months after treatment
Change from baseline in probing pocket depth
Time frame: baseline and 3, 6 and 12 months after treatment
Change from baseline in suppuration on probing
Time frame: baseline and 3, 6 and 12 months after treatment
Change from baseline in radiographic marginal bone level on standardized intraoral radiographs
Time frame: baseline and 3, 6 and 12 months after treatment
Change from baseline in modified plaque index
Time frame: baseline and 3, 6 and 12 months after treatment
Implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection
Time frame: 3, 6 and 12 months after treatment
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