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Er,Cr:YSGG and Diode Lasers in the Treatment of Peri-implantitis

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Traditional non surgical mechanical therapy
Diode laser assisted non-surgical mechancal therapy
Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-implant disease, laser therapy, Er,Cr:YSGG, Diode, MMP-9, TIMP-1

Eligibility Criteria

35 Years - 62 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Nazli Zeynep Alpaslan Yayli

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Traditional non-surgical mechanical therapy

Diode laser-assisted non-surgical mechanical therapy

Er, Cr: YSGG laser-assisted non-surgical mechanical therapy

Arm Description

Mechanical instrumentation in all groups continued with titanium Gracey curettes (8mm in diameter, Langer ½, item code: 7103, Kohler Medizintechnik, GmbH & Co, Ltd, Stockach, Germany) until the clinician gently felt that the surface was sufficiently debrided.There is no laser application. The laser tip is placed in the peri-implant sulcus but not activated.

1 week after mechanical debridment, 940 nm diode laser (Ezlase®, Biolase Technology, Inc., San Clemente, CA) has been applied with the aid of a 300 µm diameter optical fiber tip (E3-9 mm) placed approximately 1 mm above the most apical part of the peri implant pocket, parallel to the implant surface. Pocket irrigation was performed with 3% hydrogen peroxide solution for 10 seconds before and after diode laser application.The fiber was moved in apico-coronal and mesial-distal directions for a total of 30 seconds during laser light emission.The laser tip was checked every 7-8 seconds and wiped with sterile saline in order to prevent a possible coagulation or temperature increase.The laser was used in continuous pulse mode, at a power of 0.8 Watt (W), an energy density of 3J / cm2 and a spot diameter of 1 mm. Pulse width and pulse interval were applied as 20 milliseconds.

1 week after mechanical debridment, 2780 nm Er, Cr: YSGG laser (Waterlase®, Biolase Technology, Inc., San Clemente, CA), with 500 µm diameter fiberoptic periodontal tip (RFPT5-14 mm) was applied in short pulse '' H '' mode, water cooled with a non-contact sweeping motion for 30 seconds parallel to the implant surface.The settings used are: 1.5 W power, 30 Hz frequency, 50% water, 40% air, 140 s pulse duration and 1 cm spot size.

Outcomes

Primary Outcome Measures

Plaque index score (0-3)
Plaque index was measured from the 4 surfaces of each implant. The plaque index score of each implant was calculated with Silness-Loe plaque index by dividing the total value by 4. 0:absence of microbial plaque Thin film of microbial plaque along the free peri-implant margin moderate accumulation with plaque in the sulcus large amount of plaque in sulcus or pocket along the free peri-implant margin
Gingival index score (0-3)
The gingival index was measured from the 4 surfaces of each implant. The gingival index score of each implant was calculated with Silness-Loe gingival indeks by dividing the total value by 4. 0:Normal gingiva Mild inflammation: slight change in color, slight oedema, no bleeding on probing Moderate inflammation: redness,oedema and glazing, bleeding on probing Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding
Bleeding on probing (percentage)
Bleeding on probing was measured by Ainamo and Bay's gingival bleeding index from 4 surfaces of each implant. If there is bleeding after probing, it is recorded as +, if there is no bleeding it is recorded as _. Gingival bleeding index is calculated as a percentage of affected sites.
Probing depth (mm)
Probing depth (PD) (distance from peri-implant margin to peri-implant pocket base) was measured with a plastic probe (UNC 12 Colorvue probe, Hu-Friedy, Chicago, USA) in 4 regions (mesial, buccal, distal, lingual / palatinal) of each implant and recorded as mm.
Matrix Metalloproteinase-9 (MMP-9) level (ng/mL)
Samples were collected using specially prepared paper strips (PerioPaper, Oraflow, NY, USA). The strips were stored in 1.5 mL sterile eppendorf tubes with 500μl phosphate-based saline (PBS) at pH 7.4. and -40 ° C. PICF samples were collected again from the same site of the same implant at 6 months following the treatments. When the targeted number is reached, in the investigation of MMP-9 levels in PICF, enzyme-linked immunosorbent assay (ELISA) is carried out in line with the recommendations of the manufacturer (Human Matrix Metalloproteinase-9 ELISA Kit, Bioassay Technology Laboratory, Shanghai, China). Absorbance values were read with a 450 nm wavelength ELISA reader (µQuantTM ELISA Microplate Reader, BioTek® Instruments, Inc., Vermont, USA).
Tissue Inhibitors of Metalloproteinase-1 (TIMP-1) level (pg/mL)
Samples were collected using specially prepared paper strips (PerioPaper, Oraflow, NY, USA). The strips were stored in 1.5 mL sterile eppendorf tubes with 500μl phosphate-based saline (PBS) at pH 7.4. and -40 ° C. PICF samples were collected again from the same site of the same implant at 6 months following the treatments. When the targeted number is reached, in the investigation of TIMP-1 levels in PICF, enzyme-linked immunosorbent assay (ELISA) is carried out in line with the recommendations of the manufacturer (Human Tissue Inhibitors of Metalloproteinase-1 ELISA Kit, Bioassay Technology Laboratory, Shanghai, China). Absorbance values were read with a 450 nm wavelength ELISA reader (µQuantTM ELISA Microplate Reader, BioTek® Instruments, Inc., Vermont, USA).

Secondary Outcome Measures

Full Information

First Posted
January 19, 2021
Last Updated
April 13, 2021
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT04730687
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 15, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
Peri-implant disease, laser therapy, Er,Cr:YSGG, Diode, MMP-9, TIMP-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional non-surgical mechanical therapy
Arm Type
Placebo Comparator
Arm Description
Mechanical instrumentation in all groups continued with titanium Gracey curettes (8mm in diameter, Langer ½, item code: 7103, Kohler Medizintechnik, GmbH & Co, Ltd, Stockach, Germany) until the clinician gently felt that the surface was sufficiently debrided.There is no laser application. The laser tip is placed in the peri-implant sulcus but not activated.
Arm Title
Diode laser-assisted non-surgical mechanical therapy
Arm Type
Active Comparator
Arm Description
1 week after mechanical debridment, 940 nm diode laser (Ezlase®, Biolase Technology, Inc., San Clemente, CA) has been applied with the aid of a 300 µm diameter optical fiber tip (E3-9 mm) placed approximately 1 mm above the most apical part of the peri implant pocket, parallel to the implant surface. Pocket irrigation was performed with 3% hydrogen peroxide solution for 10 seconds before and after diode laser application.The fiber was moved in apico-coronal and mesial-distal directions for a total of 30 seconds during laser light emission.The laser tip was checked every 7-8 seconds and wiped with sterile saline in order to prevent a possible coagulation or temperature increase.The laser was used in continuous pulse mode, at a power of 0.8 Watt (W), an energy density of 3J / cm2 and a spot diameter of 1 mm. Pulse width and pulse interval were applied as 20 milliseconds.
Arm Title
Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
Arm Type
Active Comparator
Arm Description
1 week after mechanical debridment, 2780 nm Er, Cr: YSGG laser (Waterlase®, Biolase Technology, Inc., San Clemente, CA), with 500 µm diameter fiberoptic periodontal tip (RFPT5-14 mm) was applied in short pulse '' H '' mode, water cooled with a non-contact sweeping motion for 30 seconds parallel to the implant surface.The settings used are: 1.5 W power, 30 Hz frequency, 50% water, 40% air, 140 s pulse duration and 1 cm spot size.
Intervention Type
Device
Intervention Name(s)
Traditional non surgical mechanical therapy
Intervention Description
Mechanical instrumentation in all groups was made with titanium Gracey curettes (8mm in diameter, Langer ½, item code: 7103, Kohler Medizintechnik, GmbH & Co, Ltd, Stockach, Germany).
Intervention Type
Device
Intervention Name(s)
Diode laser assisted non-surgical mechancal therapy
Intervention Description
One week after mechanical treatment, a 940 nm diode laser (Ezlase®, Biolase Technology, Inc., San Clemente, CA) with a 300 µm diameter optical fiber tip applied approximately 1 mm above the most apical part of the peri-implant pocket, parallel to the implant surface (E3-9 mm).
Intervention Type
Device
Intervention Name(s)
Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
Intervention Description
1 week after mechanical treatment, 2780 nm Er, Cr: YSGG laser (Waterlase®, Biolase Technology, Inc., San Clemente, CA), short pulse '' H '' with 500 µm diameter fiberoptic periodontal tip (RFPT5-14 mm) mode has been applied.
Primary Outcome Measure Information:
Title
Plaque index score (0-3)
Description
Plaque index was measured from the 4 surfaces of each implant. The plaque index score of each implant was calculated with Silness-Loe plaque index by dividing the total value by 4. 0:absence of microbial plaque Thin film of microbial plaque along the free peri-implant margin moderate accumulation with plaque in the sulcus large amount of plaque in sulcus or pocket along the free peri-implant margin
Time Frame
6 months
Title
Gingival index score (0-3)
Description
The gingival index was measured from the 4 surfaces of each implant. The gingival index score of each implant was calculated with Silness-Loe gingival indeks by dividing the total value by 4. 0:Normal gingiva Mild inflammation: slight change in color, slight oedema, no bleeding on probing Moderate inflammation: redness,oedema and glazing, bleeding on probing Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding
Time Frame
6 months
Title
Bleeding on probing (percentage)
Description
Bleeding on probing was measured by Ainamo and Bay's gingival bleeding index from 4 surfaces of each implant. If there is bleeding after probing, it is recorded as +, if there is no bleeding it is recorded as _. Gingival bleeding index is calculated as a percentage of affected sites.
Time Frame
6 months
Title
Probing depth (mm)
Description
Probing depth (PD) (distance from peri-implant margin to peri-implant pocket base) was measured with a plastic probe (UNC 12 Colorvue probe, Hu-Friedy, Chicago, USA) in 4 regions (mesial, buccal, distal, lingual / palatinal) of each implant and recorded as mm.
Time Frame
6 months
Title
Matrix Metalloproteinase-9 (MMP-9) level (ng/mL)
Description
Samples were collected using specially prepared paper strips (PerioPaper, Oraflow, NY, USA). The strips were stored in 1.5 mL sterile eppendorf tubes with 500μl phosphate-based saline (PBS) at pH 7.4. and -40 ° C. PICF samples were collected again from the same site of the same implant at 6 months following the treatments. When the targeted number is reached, in the investigation of MMP-9 levels in PICF, enzyme-linked immunosorbent assay (ELISA) is carried out in line with the recommendations of the manufacturer (Human Matrix Metalloproteinase-9 ELISA Kit, Bioassay Technology Laboratory, Shanghai, China). Absorbance values were read with a 450 nm wavelength ELISA reader (µQuantTM ELISA Microplate Reader, BioTek® Instruments, Inc., Vermont, USA).
Time Frame
6 months
Title
Tissue Inhibitors of Metalloproteinase-1 (TIMP-1) level (pg/mL)
Description
Samples were collected using specially prepared paper strips (PerioPaper, Oraflow, NY, USA). The strips were stored in 1.5 mL sterile eppendorf tubes with 500μl phosphate-based saline (PBS) at pH 7.4. and -40 ° C. PICF samples were collected again from the same site of the same implant at 6 months following the treatments. When the targeted number is reached, in the investigation of TIMP-1 levels in PICF, enzyme-linked immunosorbent assay (ELISA) is carried out in line with the recommendations of the manufacturer (Human Tissue Inhibitors of Metalloproteinase-1 ELISA Kit, Bioassay Technology Laboratory, Shanghai, China). Absorbance values were read with a 450 nm wavelength ELISA reader (µQuantTM ELISA Microplate Reader, BioTek® Instruments, Inc., Vermont, USA).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inflammation in the peri-implant area, Probing depth ≥ 3 mm in one or more areas, Bleeding with probing with or without suppuration under light forces (0.25 N) Patients with bone loss [Patients with bone loss ≥ 2mm identified as peri-implantitis], There is no evidence of occlusal overload, 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: Smoking 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, Being in pregnancy or breastfeeding period, Using antibiotics and / or non-steroidal anti-inflammatory drugs in the last 3 months, Steroid and bisphosphonate use, To have any dental treatment in the last 3 months, Requiring surgical techniques in the treatment of peri-implant disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazli Zeynep Alpaslan Yayli, PhD
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmet Cemil Talmac, PhD
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Serap Keskin Tunc, PhD
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Damla Akbal, PhD
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dicle Altindal, PhD
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abdullah Seckin Ertugrul, Professor
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Study Chair
Facility Information:
Facility Name
Nazli Zeynep Alpaslan Yayli
City
Van
ZIP/Postal Code
65100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29762186
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.
Results Reference
result
PubMed Identifier
34637055
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.
Results Reference
derived

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Er,Cr:YSGG and Diode Lasers in the Treatment of Peri-implantitis

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