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

NCT04730687 | Completed

• 1 other identifier: 21.11.2018/02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Keywords

Peri-implant disease; laser therapy; Er,Cr:YSGG; Diode; MMP-9; TIMP-1

Outcome Measures

Primary Outcomes (6)

• 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 1. Thin film of microbial plaque along the free peri-implant margin 2. moderate accumulation with plaque in the sulcus 3. large amount of plaque in sulcus or pocket along the free peri-implant margin

  6 months

• 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 1. Mild inflammation: slight change in color, slight oedema, no bleeding on probing 2. Moderate inflammation: redness,oedema and glazing, bleeding on probing 3. Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding

  6 months

• 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.

  6 months

• 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.

  6 months

• 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).

  6 months

• 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).

  6 months

Study Arms (3)

Traditional non-surgical mechanical therapy

PLACEBO COMPARATOR

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.

Device: Traditional non surgical mechanical therapy

Diode laser-assisted non-surgical mechanical therapy

ACTIVE COMPARATOR

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.

Device: Diode laser assisted non-surgical mechancal therapy

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

ACTIVE COMPARATOR

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.

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

Interventions

Traditional non surgical mechanical therapy DEVICE

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).

Traditional non-surgical mechanical therapy

Diode laser assisted non-surgical mechancal therapy DEVICE

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).

Diode laser-assisted non-surgical mechanical therapy

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

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.

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

Eligibility Criteria

• Age: 35 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Nazli Zeynep Alpaslan Yayli

Van, 65100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 29762186 RESULT

• 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.

  PMID: 34637055 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Nazli Zeynep Alpaslan Yayli, PhD

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

• Ahmet Cemil Talmac, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Serap Keskin Tunc, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Damla Akbal, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Dicle Altindal, PhD

  Yuzuncu Yil University

  STUDY CHAIR

• Abdullah Seckin Ertugrul, Professor

  Izmir Katip Celebi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, DDA, Assistant professor

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 29, 2021
• Study Start: January 15, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)