Peri-ImplantitisNCT04730687
Er,Cr:YSGG and Diode Lasers in the Treatment of Peri-implantitis
A study testing Traditional non surgical mechanical therapy, Diode laser assisted non-surgical mechancal therapy and Er, Cr: YSGG laser-assisted non-surgical mechanical therapy in people with Peri-Implantitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Traditional non surgical mechanical therapy, Diode laser assisted non-surgical mechancal therapy and Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2019to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Er,Cr:YSGG and Diode Lasers in the Treatment of Peri-implantitis: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Peri-Implantitis
- Being tested
- Traditional non surgical mechanical therapy, Diode laser assisted non-surgical mechancal therapy, Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
- Keywords
- Peri-implant disease, laser therapy, Er,Cr:YSGG, Diode, MMP-9, TIMP-1
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional non surgical mechanical therapyDevice
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).
Diode laser assisted non-surgical mechancal therapyDevice
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).
Er, Cr: YSGG laser-assisted non-surgical mechanical therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 Jan 2019
- Primary completion15 Aug 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Zeynep Alpaslan Yayli, Yuzuncu Yil University
- Investigators
- Nazli Zeynep Alpaslan Yayli, PhD, Principal investigator, Yuzuncu Yil UniversityAhmet Cemil Talmac, PhD, Study chair, Yuzuncu Yil UniversitySerap Keskin Tunc, PhD, Study chair, Yuzuncu Yil UniversityDamla Akbal, PhD, Study chair, Yuzuncu Yil UniversityDicle Altindal, PhD, Study chair, Yuzuncu Yil UniversityAbdullah Seckin Ertugrul, Professor, Study chair, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730687
- Sponsor's protocol ID
- 21.11.2018/02
- Status last verified
- Apr 2021
- First submitted
- 19 Jan 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29762186Alpaslan 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.
PubMed 34637055
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Er,Cr:YSGG and Diode Lasers in the Treatment of Peri-implantitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04730687
- Acronym / sponsor ID
- 21.11.2018/02
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implant disease, laser therapy, Er,Cr:YSGG, Diode, MMP-9, TIMP-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditional non-surgical mechanical therapy | Placebo comparator | Device: Traditional non surgical mechanical therapyMechanical 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. |
| Diode laser-assisted non-surgical mechanical therapy | Active comparator | Device: Diode laser assisted non-surgical mechancal therapy1 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. |
| Er, Cr: YSGG laser-assisted non-surgical mechanical therapy | Active comparator | Device: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy1 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. |
Who may qualify
- Ages
- 35 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Inflammation in the peri-implant area,
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional non surgical mechanical therapyMechanical 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). | Device | Traditional non-surgical mechanical therapy |
| Diode laser assisted non-surgical mechancal therapyOne 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). | Device | Diode laser-assisted non-surgical mechanical therapy |
| Er, Cr: YSGG laser-assisted non-surgical mechanical therapy1 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. | Device | Er, Cr: YSGG laser-assisted non-surgical mechanical therapy |
Primary outcome
Plaque index score (0-3)
Time frame: 6 months
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
Gingival index score (0-3)
Time frame: 6 months
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
Bleeding on probing (percentage)
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 6 months
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)
Time frame: 6 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Results publication: PubMed 29762186Sinjab 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.
- Derived from this study: PubMed 34637055Alpaslan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazli Zeynep Alpaslan Yayli, PhD principal investigator
Yuzuncu Yil University
Ahmet Cemil Talmac, PhD study chair
Yuzuncu Yil University
Serap Keskin Tunc, PhD study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional non surgical mechanical therapy, Diode laser assisted non-surgical mechancal therapy and Er, Cr: YSGG laser-assisted non-surgical mechanical therapy in people with Peri-Implantitis, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque index score (0-3) (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04730687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.