Università Vita-Salute San Raffaele
Milan, Milano, 20100, Italy
NCT Number: NCT03451981
Peri-implantitis is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy.
Non-surgical therapy of peri-implant disease, especially when bone loss is not high, appears to be partially effective in resolving the disease. In several cases, however, only limited improvements have been reported in the main clinical parameters (bleeding at the survey and presence of the pocket) and there is a clear tendency to relapse of the disease.
In these cases it is therefore recommended to consider adjunctive therapies. Numerous approaches have been used for implant surface decontamination including mechanical, chemical and treatments by means of air-powder or laser.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of peri-implantitis.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Milan, Milano, 20100, Italy
Peri-implantitis, defined as an inflammatory lesion in the surrounding peri-implant tissues with loss of supporting bone, is an important disease entity as a result of its high prevalence and the lack of a standard mode of therapy. Although the current epidemiological data are limited, peri-implantitis affects 28-56% of the subjects and 12-43% of the implants.
Numerous approaches have been used for implant surface decontamination during peri-implant surgery, including mechanical, chemical and laser treatments. Using conventional mechanical means, eradication of pathogens on implant surfaces with threads and often with rough surface structures is difficult. Treatment models, such as debridment, effectively used to treat teeth with periodontitis, cannot be used in the same way on rough threaded implant surfaces. The implant rough surface structure also provides the bacteria with ''protected areas'', inaccessible to conventional mechanical removal.
A treatment protocol that may offer an advantage over traditional mechanical treatment includes the use of laser therapy. Data have shown that treatments with Er:YAG lasers have a bactericidal effect. Er:YAG laser treatment can debride the implant surface effectively and safely. Slightly better clinical results in terms of bleeding on probing and clinical attachment level have been reported by Er:YAG laser treatment as compared with traditional non-surgical mechanical debridement with curette and chlorhexidine.
The air abrasive method for the removal of bacterial plaque on tooth surfaces has also been used in the treatment of peri-implantitis, demonstrating no relevant adverse effects. Until recently, air-polishing devices have used a slurry of water and sodium bicarbonate (NaHCO3) and pressurized air/water. A less abrasive method using an amino acid glycine has been proven to be effective in removing bacterial biofilm structures in deep periodontal pockets and safe by not causing emphysema. Moreover the use of a glycine-based powder does not seem to cause titanium implant surface changes.
The aim of the present randomized controlled clinical trial will be to assess the efficacy in improving clinical parameters of two further methods of implant surface decontamination (Er:YAG laser or air-abrasive device) after mechanical cleaning during non surgical treatment of peri-implantitis.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments (titanium curettes) and the implant surface will be cleaned
Other names: titanium curettes
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments (titanium curettes) and the implant surface will be cleaned. Furthermore, Er:YAG laser treatment will be provided on the implant surface.
mechanical debridement: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments (titanium curettes) and the implant surface will be cleaned. Furthermore, an Air-Powder treatment will be provided on the implant surface.
Time frame: baseline, 1, 3, 6 months
changes in probing pocket depth, measured from the mucosal margin to the bottom of the pocket
Time frame: baseline,1, 3, 6 months
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: 1,3,6 months
residual PPD ≤5 mm with BoP present at no more than one site and no SoP (Tonetti et al., 2023), assessed at the implant level.
Università Vita-Salute San Raffaele
Other
Evaluation of the Adjunctive Use of Er:YAG Laser or Erythritol Air-polishing in the Non-surgical Treatment of Peri-implantitis: a RCT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT06083246
Mouth Diseases, Peri-Implantitis
Pavia, Lombardy, Italy
View Trial DetailsNCT05024760
Dental Implant Failed, Implant Infection
Tacoma, Washington, United States
View Trial DetailsNCT07700628
Mouth Diseases, Peri-Implantitis
Caserta, CE, Italy
View Trial DetailsNCT07678892
Mouth Diseases, Peri-Implantitis
Kristianstad, Sweden
View Trial Details