Hatay Mustafa Kemal University
Hatay, 31000, Turkey (Türkiye)
Location contact
Aysegul Sari, PhD
CONTACT
Mehmet Ali Gunenc, DDs
CONTACT
Mehmet Ali Günenç, DDs
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07128134
The main objective of this study is to evaluate the clinical efficacy of low-level laser therapy (LLLT) in addition to non-surgical periodontal treatment in patients with peri-implantitis. The study aims to investigate the anti-inflammatory and regenerative effects of low-level laser therapy on peri-implant soft and hard tissues and to reveal its contribution to treatment success.
In this context, the specific objectives of the study are as follows:
1. To evaluate the effects of LLLT added to non-surgical mechanical treatment on clinical parameters such as plaque index, probing depth, bleeding index, and clinical attachment level. 2. To examine the contributions of laser therapy to tissue healing by analyzing biochemical markers in peri-implant sulcular fluid over time.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Hatay, 31000, Turkey (Türkiye)
Aysegul Sari, PhD
CONTACT
Mehmet Ali Gunenc, DDs
CONTACT
Mehmet Ali Günenç, DDs
PRINCIPAL_INVESTIGATOR
This study will include volunteers who were diagnosed with peri-implantitis based on clinical and radiological examinations at the Department of Periodontology, Faculty of Dentistry, Hatay Mustafa Kemal University.
Seventy-two patients will be included in the study. In our study, patients will be divided into two groups. Thirty-six patients in the test group will receive low-level laser therapy in addition to non-surgical periodontal treatment. Thirty-six patients in the control group will receive only non-surgical periodontal treatment.
Periodontal indexes including plaque index, gingival index, bleeding on probing, probing pocket depth, and clinical attachment level will be recorded and peri-implant sulcus fluid will be collected from patients for routine diagnostic procedures. These measurements will be performed at baseline and at 1.5th and 3rd months by same researcher.
The following are required for a diagnosis of peri-implantitis:
Study Treatment Protocol:
In the test group diagnosed with peri-implantitis, low-level laser therapy (LLLT) will be administered three times (on the same day as the initial treatment, on the 3rd day, and on the 7th day) in addition to non-surgical periodontal treatment by using A 940 nm indium gallium arsenide phosphor diode laser (Epic Biolase, Irvine, CA, USA).
PIOS regenerative (periostin) and inflammatory (vascular endothelial growth factor (VEGF), and interleukin-1 beta (IL-1ß)) biomarkers will be analyzed biochemically using the ELISA method (Enzyme-Linked Immunosorbent Assay) at the Department of Biochemistry, Faculty of Medicine, Hatay Mustafa Kemal University.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Although low-level laser therapy has been applied in cases of periodontitis, there are only a limited number of studies investigating its additional benefits in implants with peri-implantitis. This study aims to contribute to the literature on this subject.
In addition to surgical periodontal treatment, low-level laser therapy (LLLT) was applied three times (on the same day as the initial treatment, on the third day, and on the seventh day) to the implants in the test group diagnosed with peri-implantitis. The 940 nm indium gallium arsenide phosphor diode laser (Epic Biolase, Irvine, CA, USA) will be applied perpendicular to the periodontal pocket for 20 seconds at a fixed distance of 15 mm and a continuous wavelength (3.41 J/cm2 application with a 1.76 cm2 spot and 0.3 W average output).
Peri-implantitis diagnosis will be made in the control group, and non-surgical periodontal treatment of implants will be performed using titanium curettes (Hu-Friedy, Chicago, IL, USA).
Time frame: 0-3 month
In peri-implantitis sites, Plaque Index (Silness-Löe), Gingival Index (Löe-Silness), bleeding on probing, probing pocket depth, and clinical attachment level scores will be recorded before and after non-surgical treatment with or without adjunctive low-level laser therapy
Time frame: 0-3 month
Periostin and vascular endothelial growth factor levels in peri-implant crevicular fluid will be measured before and after non-surgical treatment with or without adjunctive low-level laser therapy in peri-implantitis sites, using the ELISA immunoassay technique.
Time frame: 0-3 month
Interleukin-1 beta levels in peri-implant crevicular fluid will be measured before and after non-surgical treatment with or without adjunctive low-level laser therapy in peri-implantitis sites, using the ELISA immunoassay technique.
Contact information is provided by the study sponsor or research team.
Aysegul Sari, PhD
CONTACT
Mehmet A Gunenc, DDs
CONTACT
Mustafa Kemal University
Other
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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.
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