Clinical trial NCT01852253: Implant Surface Decontamination With 2 % Chlorhexidine in Peri-implantitis Treatment
Official title: Clinical and Microbiological Evaluation Implant Surface Decontamination With 2% Chlorhexidine in the Surgical Treatment of Peri-implantitis; a Double Blind Controlled Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Peri-implantitis
Keywords: Dental implants
Periodontal diseases
Peri-implantitis
Chlorhexidine
Microbiology
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The patient is at least 18 years of age;
* The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone more than or equal to 2 mm as compared to a fixed reference point on the dental implant, in combination with bleeding and/or suppuration on probing and a peri-implant probing depth more than or equal to 5 mm;
* The implants have been exposed to the oral environment for at least two years;
* The patient is capable of understanding and giving informed consent.

Exclusion Criteria:

* Medical and general contraindications for the surgical procedures;
* A history of local radiotherapy to the head and neck region;
* Pregnancy and lactation;
* Insulin dependent diabetes;
* Systemic use of antibiotics during the last 2 months;
* Long-term use of anti-inflammatory drugs;
* Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
* Active, uncontrolled periodontal pathology of the remaining dentition;
* Local use of antibiotics or use of other anti-septic / antimicrobial therapies in the oral cavity during the last 2 months;
* Bruxism;
* Implants placed in skin grafted areas;
* Implants with bone loss due to other reasons than bacterial infection (e.g. loose screw, inadequate positioning of the implant);
* Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
* Implant mobility;
* Implants at which no position can be identified where proper probing measurements can be performed;
* Previous surgical treatment of the peri-implantitis lesions;
* Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curettage).

Primary outcomes:
measure: Change from baseline in modified bleeding index.
timeFrame: baseline, 3, 6 and 12 months after treatment
Secondary outcomes:
measure: Change in microbial composition of the biofilm covering the dental implant surface
timeFrame: during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure'
measure: Microbiological composition of the peri-implant sulcus
timeFrame: before treatment and 3, 6 and 12 months after treatment
measure: Change from baseline in probing pocket depth
timeFrame: baseline and 3, 6 and 12 months after treatment
measure: Change from baseline in suppuration on probing
timeFrame: baseline and 3, 6 and 12 months after treatment
measure: Change from baseline in radiographic marginal bone level on standardized intraoral radiographs
timeFrame: baseline and 3, 6 and 12 months after treatment
measure: Change from baseline in modified plaque index
timeFrame: baseline and 3, 6 and 12 months after treatment
measure: 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
timeFrame: 3, 6 and 12 months after treatment
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References:
citation: de Waal YC, Raghoebar GM, Huddleston Slater JJ, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination during surgical peri-implantitis treatment: a randomized, double-blind, placebo-controlled trial. J Clin Periodontol. 2013 Feb;40(2):186-95. doi: 10.1111/jcpe.12034. Epub 2012 Dec 4.
citation: de Waal YC, Raghoebar GM, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. Clin Oral Implants Res. 2015 Sep;26(9):1015-23. doi: 10.1111/clr.12419. Epub 2014 May 26.