Clinical trial NCT04730687: Er,Cr:YSGG and Diode Lasers in the Treatment of Peri-implantitis
Official title: Er,Cr:YSGG and Diode Lasers in the Treatment of Peri-implantitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Peri-implant disease
laser therapy
Er,Cr:YSGG
Diode
MMP-9
TIMP-1
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study, 940 nm diode laser and 2780 nm erbium, chromium doped: yttrium, scandium, gallium, garnet (Er, Cr: YSGG) laser were used in the non-surgical treatment of peri-implant diseases in addition to mechanical treatment. And the effects of dental lasers on clinical parameters and matrix metalloproteinase 9 (MMP-9) and tissue inhibitors of matrix metalloproteinases-1 (TIMP-1) levels in peri-implant crevicular fluid were evaluated.

Detailed description: With the widespread use of dental implants, there is an increase in technical and biological complications. These complications are called peri-implant diseases in general terms. When peri-implant diseases are not treated, a process that progresses to the loss of the affected implant may develop, but there is still no accepted consensus on their treatment.When performing treatment procedures, it is recommended not only to remove inflamed tissues but also to decontaminate infected implant surfaces.Recently, with the development of laser technologies, the use of dental lasers in implant surface detoxification has come to the fore. Dental lasers attract increasing attention due to their anti-infective properties, easy handling and haemostatic effects against periodontal pathogens.Diode lasers attract attention with their safety when used directly on the implant surface, soft tissue penetration, antibacterial and biostimulating properties. They detoxify implant surfaces by killing pathogenic bacteria through photothermal effects and neutralizing bacterial endotoxins. Erbium lasers also show promising results in implant treatment due to their advantageous properties such as soft and hard tissue ablation and decontamination. Er, Cr: YSGG lasers have the ability to debride microstructured surfaces of dental implants without causing mechanical damage, thanks to their ability to work with water.Today, many researchers investigate the effectiveness of dental lasers in the treatment of peri-implant diseases, but it has not yet been proven whether they have an additional contribution. It is observed that studies mostly focus on clinical parameters. However, it is stated that periodontal probing and radiographs, which are used as common diagnostic methods, may give erroneous results. These methods refer only to pre-existing destruction rather than current disease activity. A model predicting the course of peri-implant disease has not yet been defined, but biomarkers may offer considerable potential for disease activity.Biomarkers are widely used in medicine to objectively determine disease state or responses to a therapeutic intervention. Gingival fluid (GCF) biomarkers have moderate diagnostic validity in periodontitis. It is stated that biomarkers in peri-implant groove fluid (PICF) also give promising results in terms of diagnosis and prognostic values. MMP-8 and MMP-9, the two main collagen degrading enzymes in GCF, are secreted from neutrophils during disease activation and are responsible for extracellular matrix degradation. TIMP-1, a major inhibitor of MMPs, has been reported to be released at high levels in inflamed gums.

In the literature review, it has been observed that there are quite a limited number of human clinical studies investigating the effect of dental lasers of different wavelengths on treatment results in the treatment of peri-implant disease at the clinical and molecular level. The aim of this study is to investigate the effects of 940 nm diode laser and 2780 nm Er, Cr: YSGG laser-assisted non-surgical mechanical treatment on clinical parameters and MMP-9 and TIMP-1 levels in PICF in individuals with peri-implant disease.

Eligibility criteria: Inclusion Criteria:

1. Inflammation in the peri-implant area,

   1. Probing depth ≥ 3 mm in one or more areas,
   2. Bleeding with probing with or without suppuration under light forces (0.25 N)
   3. Patients with bone loss \[Patients with bone loss ≥ 2mm identified as peri-implantitis\],
2. There is no evidence of occlusal overload,
3. Implant-supported fixed prosthesis that has been in use for at least 6 months in the mouth and does not interfere with the evaluation of clinical parameters.

Exclusion Criteria:

1. Smoking
2. Having a systemic disease that may affect the treatment results such as uncontrolled diabetes, metabolic bone diseases, hematological disorders, radiotherapy in the head and neck region, kidney disease,
3. Being in pregnancy or breastfeeding period,
4. Using antibiotics and / or non-steroidal anti-inflammatory drugs in the last 3 months,
5. Steroid and bisphosphonate use,
6. To have any dental treatment in the last 3 months,
7. Requiring surgical techniques in the treatment of peri-implant disease.

Primary outcomes:
measure: Plaque index score (0-3)
timeFrame: 6 months
measure: Gingival index score (0-3)
timeFrame: 6 months
measure: Bleeding on probing (percentage)
timeFrame: 6 months
measure: Probing depth (mm)
timeFrame: 6 months
measure: Matrix Metalloproteinase-9 (MMP-9) level (ng/mL)
timeFrame: 6 months
measure: Tissue Inhibitors of Metalloproteinase-1 (TIMP-1) level (pg/mL)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Nazli Zeynep Alpaslan Yayli
Study officials:
affiliation: Yuzuncu Yıl University
name: Nazli Zeynep Alpaslan Yayli, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuzuncu Yıl University
name: Ahmet Cemil Talmac, PhD
role: STUDY_CHAIR
affiliation: Yuzuncu Yıl University
name: Serap Keskin Tunc, PhD
role: STUDY_CHAIR
affiliation: Yuzuncu Yıl University
name: Damla Akbal, PhD
role: STUDY_CHAIR
affiliation: Yuzuncu Yıl University
name: Dicle Altindal, PhD
role: STUDY_CHAIR
affiliation: Izmir Katip Celebi University
name: Abdullah Seckin Ertugrul, Professor
role: STUDY_CHAIR
References:
citation: Sinjab K, Garaicoa-Pazmino C, Wang HL. Decision Making for Management of Periimplant Diseases. Implant Dent. 2018 Jun;27(3):276-281. doi: 10.1097/ID.0000000000000775.
citation: Alpaslan Yayli NZ, Talmac AC, Keskin Tunc S, Akbal D, Altindal D, Ertugrul AS. Erbium, chromium-doped: yttrium, scandium, gallium, garnet and diode lasers in the treatment of peri-implantitis: clinical and biochemical outcomes in a randomized-controlled clinical trial. Lasers Med Sci. 2022 Feb;37(1):665-674. doi: 10.1007/s10103-021-03436-5. Epub 2021 Oct 12.