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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% chlorhexidine | Active Comparator | Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline and 1 minute of local application of a 2 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds. |
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| 0.12% chlorhexidine | Sham Comparator | Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline and 1 minute of local application of a 0.12 % chlorhexidine solution. After 1 minute of saline rinsing the gingival flap will be returned slightly apical (in order to reduce pockets) and will be firmly sutured. The surgery is followed by 2 weeks of rinsing with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% chlorhexidine | Procedure |
| ||
| 0.12% chlorhexidine |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in modified bleeding index. | baseline, 3, 6 and 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbial composition of the biofilm covering the dental implant surface | during treatment: 'after granulation tissue removal' and 'after mechanical and chemical decontamination procedure' | |
| Microbiological composition of the peri-implant sulcus |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713 AV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23211012 | Background | 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. | |
| 24861411 | Derived |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| before treatment and 3, 6 and 12 months after treatment |
| Change from baseline in probing pocket depth | baseline and 3, 6 and 12 months after treatment |
| Change from baseline in suppuration on probing | baseline and 3, 6 and 12 months after treatment |
| Change from baseline in radiographic marginal bone level on standardized intraoral radiographs | baseline and 3, 6 and 12 months after treatment |
| Change from baseline in modified plaque index | 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 | 3, 6 and 12 months after treatment |
| 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. |