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Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. The goals of peri-implantitis treatment is the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). For this decontamination of the implant surface is mandatory. In order to increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the peri-implant pocket probing depth at 12 months.
Peri-implantitis is a pathological condition occurring in tissues around dental implants, characterized by inflammation in the peri-implant connective tissue and progressive loss of supporting bone. Peri-implantitis is a disease with increasing incidence that, if left untreated, leads to implant loss. The etiological factors of peri-implant infections are similar to those involved in periodontal diseases. Consequently, the goals of peri-implantitis treatment must be the resolution of peri-implant soft tissue inflammation and stabilization of the bony attachment (e.g., the level of osseointegration). This can only be achieved under the condition that the majority of bacterial biofilms and hard deposits are eliminated on the implant surface to create a biologically acceptable surface conducive to wound healing. Decontamination of the implant surface is mandatory to resolve the inflammatory process and to establish healthy peri-implant tissues. To increase implant surface decontamination, several adjunctive tools have been proposed and investigated both in pre-clinical and clinical studies such as the use of photodynamic therapy and lasers. So far, no data are available to clearly demonstrate the efficacy of the adjunctive use of a diode laser in the non-surgical treatment of peri-implantitis. Therefore, the aim of the present randomized controlled trial (RCT) is to investigate the adjunctive effect of the application of a diode laser to treat peri-implantitis lesions by means of a non-surgical approach. A total of 30 patients is randomly allocated to two groups. The test group receives 3 x nonsurgical mechanical treatment with diode laser application whereas the control group receives the same treatment with sham laser application. The primary outcome is the mean peri-implant pocket probing depth (PPD) at 12 months. The secondary endpoints are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Sham Comparator | Non-surgical mechanical instrumentation 3x. Each time the laser will be held in place but will not be activated. |
|
| laser | Experimental | Non-surgical mechanical instrumentation 3x with adjunctive diode laser application according to the protocol of the Department of Periodontology, University of Bern |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diode laser application | Device | After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Adjunctive diode laser (settings: 810 nm, 2.5 W, 50 Hz, 10 ms) will be applied 3x for 30 s (i.e., 90 s per appointment) using a 400-lm thick fiber (WhiteStar, Orcos Medical AG, Küsnacht, Switzerland) in the test group. In the control group, non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way. The laser tip will be checked after 4-5 s for coagulation to prevent hotspots in the soft tissues. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peri-implant pocket probing depth (PPD) | the difference between baseline PPD and PPD after 12 months | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change at deepest PPD (mm) | Difference of baseline and final PPD of the deepest measurment | at 12 months |
| Change in probing attachment level (PAL) (mm) | Difference of attachment level from baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, University of Bern | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Randomised placebo controlled monocentric trial
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| Sham Diode laser | Device | After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way. |
|
| at 12 months |
| Change in the % of implants with BoP / SUP | Difference between baseline and final BoP | at 12 months |
| Mean radiographic bone fill (mm) at mesial and distal sites | the distance from the implant shoulder to the bone crest | at 12 months |
| Change in width of keratinized mucosa (KM) (mm) | the difference between the baseline and final amount of KM | at 12 months |
| Change in microbial samples composition | at 6 and 12 months |
| Changes in patients' related outcomes measures (PROMs) by means of a Visual Analogue Scale (VAS) (range: 0-10) | at 12 months |
| Change in peri-implant crevicular fluid (PICF) composition | at 12 months |