xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06031467</url>
    </required_header>
    <id_info>
      <org_study_id>29.01.2020/11</org_study_id>
      <nct_id>NCT06031467</nct_id>
    </id_info>
    <brief_title>Er,Cr:YSGG Laser Application in Peri-implantitis</brief_title>
    <official_title>Evaluation of the Effect of Erbium, Chromium:Yttrium-scandium-gallium-garnet (Er,Cr:YSGG) Laser Application on Peri-Implant Crevicular Fluid RANKL and OPG Levels in the Treatment of Peri-implantitis: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yuzuncu Yıl University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yuzuncu Yıl University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In the present study, investigators, aimed to evaluate the effect of erbium,&#xD;
        chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser application combined with&#xD;
        mechanical debridement (MD) on clinical parameters and biochemical parameters such as&#xD;
        receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in&#xD;
        patients with peri-implant diseases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Peri-implantitis is a plaque-associated which involves the tissues around dental implants&#xD;
        characterized by inflammation and progressive loss of the supporting alveolar bone. According&#xD;
        to a meta-analysis and systematic review, the prevalence of peri-implantitis is about 22%.&#xD;
        Biofilm, poor plaque control, and poor dental care after dental implant are implicated in the&#xD;
        etiology of disease.&#xD;
  &#xD;
        Surface decontamination of the implant is the cornerstone of peri-implantitis treatment.&#xD;
        However, there is no sufficient evidence to demonstrate the superiority of a specific&#xD;
        decontamination protocol in the literature. Nevertheless, a review recommended the potential&#xD;
        use of laser-assisted procedures as an adjunct to mechanical instrumentation and implant&#xD;
        detoxification in both non-surgical and regenerative interventions for the treatment of&#xD;
        peri-implant diseases. Several studies have examined the role of a variety of laser types in&#xD;
        both periodontal and peri-implant treatments and laser application has been shown to play a&#xD;
        central role in wound healing and tissue regeneration.&#xD;
  &#xD;
        Erbium lasers such as erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) use&#xD;
        mid-infrared wavelengths which are highly absorbed by water and hydroxyapatite crystals and&#xD;
        minerals. In a recent in vitro study, Er,Cr:YSGG laser has been shown to be a safe method in&#xD;
        the treatment of peri-implantitis with the dual wavelength protocol. In the literature, there&#xD;
        is a limited number of studies using Er,Cr:YSGG laser in the treatment of peri-implantitis in&#xD;
        the in vivo setting. Although limited, favorable results have been described in a case report&#xD;
        with 18-month follow-up, case reports of including 11 patients, and randomized-controlled&#xD;
        clinical studies. Taken together, Er,Cr:YSGG laser seems to be an effective treatment&#xD;
        modality in reducing clinical symptoms of peri-implantitis.&#xD;
  &#xD;
        The detection of specific biomarkers in the peri-implant crevicular fluid (PICF) is promising&#xD;
        to objectively evaluate peri-implant inflammation at baseline and assess treatment efficacy.&#xD;
        Biomarkers are host response molecules which reflect a biological state and help to&#xD;
        distinguish healthy from diseased tissues or to evaluate disease and its severity.&#xD;
  &#xD;
        Recent discoveries regarding the receptor activator of nuclear factor-kappa B ligand (RANKL)&#xD;
        and osteoprotegerin (OPG) receptor activator that induce and inhibit osteoclast&#xD;
        differentiation have shown that both markers play a role in the molecular network of&#xD;
        peri-implant bone resorption. The RANKL is a member of tumor necrosis factor (TNF)&#xD;
        superfamily which interacts on osteoclastogenesis. It is secreted by osteoblasts,&#xD;
        fibroblasts, and activated T cells and is associated with RANK as a surface-bound molecule&#xD;
        which stimulates osteoclast activity. On the other hand, OPG is a soluble decoy receptor for&#xD;
        RANKL and expressed by osteoblasts. It also inhibits the osteoclast differentiation and&#xD;
        prevents the interaction between RANKL and RANK.&#xD;
  &#xD;
        Previous studies have shown high RANKL levels in the crevicular fluid of patients with&#xD;
        periodontitis and peri-implantitis compared to healthy dental sites. However, there are&#xD;
        controversial results regarding OPG. Several studies have reported significantly higher OPG&#xD;
        and RANK levels at peri-implant disease sites compared to healthy implant sites. In addition,&#xD;
        significantly higher RANKL protein levels and significantly lower OPG protein levels have&#xD;
        been reported in periodontitis tissue. In a study, the PICF level of soluble RANKL was not&#xD;
        significantly correlated with clinical parameters and OPG. However, the authors found a&#xD;
        positive correlation between the total OPG level and PICF volume, bleeding on probing (BoP)&#xD;
        and gingival index (GI).&#xD;
  &#xD;
        To the best of investigators' knowledge, there is no study investigating the effect of&#xD;
        Er,Cr:YSGG laser as an adjunct to mechanical debridement (MD) on RANKL and OPG in the&#xD;
        treatment of peri-implantitis. In the present study, investigators, therefore aimed to&#xD;
        evaluate the effect of Er,Cr:YSGG laser application combined with MD on clinical parameters&#xD;
        and biochemical parameters such as RANKL and OPG in patients with peri-implant diseases.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 3, 2020</start_date>
    <completion_date type="Actual">April 8, 2022</completion_date>
    <primary_completion_date type="Actual">April 8, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Probing depth (mm)</measure>
      <time_frame>6 months</time_frame>
      <description>Probing depth (PD) (distance from peri-implant margin to peri-implant pocket base) was measured with a plastic probe in 4 regions (mesial, buccal, distal, lingual / palatial) of each implant and recorded as mm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Receptor activator of nuclear factor-kappa B ligand (RANKL) level (pg/mL)</measure>
      <time_frame>6 months</time_frame>
      <description>All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure RANKL levels in the PICF samples in accordance with the manufacturer's instructions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Osteoprotegerin (OPG) level (ng/mL)</measure>
      <time_frame>6 months</time_frame>
      <description>All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure OPG levels in the PICF samples in accordance with the manufacturer's instructions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plaque index score (0-3)</measure>
      <time_frame>6 months</time_frame>
      <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.&#xD;
  0:absence of microbial plaque&#xD;
  Thin film of microbial plaque along the free peri-implant margin&#xD;
  moderate accumulation with plaque in the sulcus&#xD;
  large amount of plaque in sulcus or pocket along the free peri-implant margin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival index score (0-3)</measure>
      <time_frame>6 months</time_frame>
      <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 index by dividing the total value by 4.&#xD;
  0:Normal gingiva&#xD;
  Mild inflammation: slight change in color, slight oedema, no bleeding on probing&#xD;
  Moderate inflammation: redness,oedema and glazing, bleeding on probing&#xD;
  Severe inflammation: marked redness and oedema, ulceration, tendency to spontaneous bleeding</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on probing (percentage)</measure>
      <time_frame>6 months</time_frame>
      <description>Bleeding on probing was measured 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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">49</enrollment>
    <condition>Peri-Implantitis</condition>
    <arm_group>
      <arm_group_label>Non-surgical mechanical therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Titanium curettes were used for non-surgical mechanical therapy in both groups under local anesthesia. The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt. The control group received mechanical therapy alone.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Er, Cr: YSGG laser-assisted non-surgical mechanical therapy</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Titanium curettes were used for non-surgical mechanical therapy in both groups under local anesthesia. The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt. The laser group received mechanical therapy followed by Er;Cr;YSGG laser.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Er, Cr: YSGG laser-assisted non-surgical mechanical therapy</intervention_name>
      <description>The laser group received mechanical therapy followed by Er;Cr;YSGG laser. Laser application was performed using the bottom-up technique. Therefore, the tip was retracted about 1 mm after it was placed on the bottom of the pocket and slowly moved in the coronal direction to the parallel to the implant surface.</description>
      <arm_group_label>Er, Cr: YSGG laser-assisted non-surgical mechanical therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Non-surgical mechanical therapy</intervention_name>
      <description>Traditional non surgical mechanical therapy Mechanical instrumentation in all groups was made with titanium curettes.The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt.</description>
      <arm_group_label>Non-surgical mechanical therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  bone loss as evidenced by X-ray and inflammatory symptoms in the soft tissue, bleeding&#xD;
               and/or suppuration around the implant compatible with peri-implantitis (each patient&#xD;
               had a single dental implant or the implant in the deepest pathological pocket not&#xD;
               requiring surgical intervention was chosen in case of peri-implantitis in multiple&#xD;
               implants);&#xD;
  &#xD;
            -  radiotherapy or chemotherapy-naïve patients;&#xD;
  &#xD;
            -  having no bone disease such as osteoporosis or osteopetrosis;&#xD;
  &#xD;
            -  receiving no bisphosphonate therapy;&#xD;
  &#xD;
            -  having functional prosthetic loading on the implant for at least six months&#xD;
  &#xD;
            -  requiring no advanced surgical technique for the treatment of peri-implantitis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having systemic diseases such as diabetes, autoimmune disorder, renal or hepatic&#xD;
               impairment;&#xD;
  &#xD;
            -  having uncontrolled periodontal disease in natural teeth existing in the mouth;&#xD;
  &#xD;
            -  smoking habit;&#xD;
  &#xD;
            -  having parafunctional habits which affect osseointegration of the dental implant;&#xD;
  &#xD;
            -  receiving antibiotherapy three months before the diagnosis of peri-implantitis;&#xD;
  &#xD;
            -  having non-osseointegrated dental implant;&#xD;
  &#xD;
            -  pregnancy and lactation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>28 Years</minimum_age>
      <maximum_age>63 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nazli Zeynep Alpaslan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Van Yuzuncu Yil University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dicle Altindal, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Van Yuzuncu Yil University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Damla Akbal, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Private Dental Clinic</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ahmet Cemil Talmac, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Van Yuzuncu Yil University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Serap Keskin Tunc, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Saglik Bilimleri Universitesi</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Abdullah Seckin Ertugrul, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Izmir Katip Celebi University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Nazli Zeynep Alpaslan</name>
        <address>
          <city>Van</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <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.</citation>
      <PMID>34637055</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
      <investigator_full_name>Nazli Zeynep Alpaslan</investigator_full_name>
      <investigator_title>DDS, PhD, Assoc. Prof. Dr</investigator_title>
    </responsible_party>
    <keyword>Er:Cr:YSGG</keyword>
    <keyword>biomarkers</keyword>
    <keyword>laser</keyword>
    <keyword>osteoprotegerin</keyword>
    <keyword>peri-implantitis</keyword>
    <keyword>RANKL</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peri-Implantitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031467
  org study id: 29.01.2020/11
  nct id: NCT06031467
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In the present study, investigators, aimed to evaluate the effect of erbium,
        chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) laser application combined with
        mechanical debridement (MD) on clinical parameters and biochemical parameters such as
        receptor activator of nuclear factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in
        patients with peri-implant diseases.
  Peri-implantitis is a plaque-associated which involves the tissues around dental implants
        characterized by inflammation and progressive loss of the supporting alveolar bone. According
        to a meta-analysis and systematic review, the prevalence of peri-implantitis is about 22%.
        Biofilm, poor plaque control, and poor dental care after dental implant are implicated in the
        etiology of disease.
  
        Surface decontamination of the implant is the cornerstone of peri-implantitis treatment.
        However, there is no sufficient evidence to demonstrate the superiority of a specific
        decontamination protocol in the literature. Nevertheless, a review recommended the potential
        use of laser-assisted procedures as an adjunct to mechanical instrumentation and implant
        detoxification in both non-surgical and regenerative interventions for the treatment of
        peri-implant diseases. Several studies have examined the role of a variety of laser types in
        both periodontal and peri-implant treatments and laser application has been shown to play a
        central role in wound healing and tissue regeneration.
  
        Erbium lasers such as erbium, chromium:yttrium-scandium-gallium-garnet (Er,Cr:YSGG) use
        mid-infrared wavelengths which are highly absorbed by water and hydroxyapatite crystals and
        minerals. In a recent in vitro study, Er,Cr:YSGG laser has been shown to be a safe method in
        the treatment of peri-implantitis with the dual wavelength protocol. In the literature, there
        is a limited number of studies using Er,Cr:YSGG laser in the treatment of peri-implantitis in
        the in vivo setting. Although limited, favorable results have been described in a case report
        with 18-month follow-up, case reports of including 11 patients, and randomized-controlled
        clinical studies. Taken together, Er,Cr:YSGG laser seems to be an effective treatment
        modality in reducing clinical symptoms of peri-implantitis.
  
        The detection of specific biomarkers in the peri-implant crevicular fluid (PICF) is promising
        to objectively evaluate peri-implant inflammation at baseline and assess treatment efficacy.
        Biomarkers are host response molecules which reflect a biological state and help to
        distinguish healthy from diseased tissues or to evaluate disease and its severity.
  
        Recent discoveries regarding the receptor activator of nuclear factor-kappa B ligand (RANKL)
        and osteoprotegerin (OPG) receptor activator that induce and inhibit osteoclast
        differentiation have shown that both markers play a role in the molecular network of
        peri-implant bone resorption. The RANKL is a member of tumor necrosis factor (TNF)
        superfamily which interacts on osteoclastogenesis. It is secreted by osteoblasts,
        fibroblasts, and activated T cells and is associated with RANK as a surface-bound molecule
        which stimulates osteoclast activity. On the other hand, OPG is a soluble decoy receptor for
        RANKL and expressed by osteoblasts. It also inhibits the osteoclast differentiation and
        prevents the interaction between RANKL and RANK.
  
        Previous studies have shown high RANKL levels in the crevicular fluid of patients with
        periodontitis and peri-implantitis compared to healthy dental sites. However, there are
        controversial results regarding OPG. Several studies have reported significantly higher OPG
        and RANK levels at peri-implant disease sites compared to healthy implant sites. In addition,
        significantly higher RANKL protein levels and significantly lower OPG protein levels have
        been reported in periodontitis tissue. In a study, the PICF level of soluble RANKL was not
        significantly correlated with clinical parameters and OPG. However, the authors found a
        positive correlation between the total OPG level and PICF volume, bleeding on probing (BoP)
        and gingival index (GI).
  
        To the best of investigators' knowledge, there is no study investigating the effect of
        Er,Cr:YSGG laser as an adjunct to mechanical debridement (MD) on RANKL and OPG in the
        treatment of peri-implantitis. In the present study, investigators, therefore aimed to
        evaluate the effect of Er,Cr:YSGG laser application combined with MD on clinical parameters
        and biochemical parameters such as RANKL and OPG in patients with peri-implant diseases.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Probing depth (mm)
  time frame: 6 months
  description: Probing depth (PD) (distance from peri-implant margin to peri-implant pocket base) was measured with a plastic probe in 4 regions (mesial, buccal, distal, lingual / palatial) of each implant and recorded as mm.
  measure: Receptor activator of nuclear factor-kappa B ligand (RANKL) level (pg/mL)
  time frame: 6 months
  description: All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure RANKL levels in the PICF samples in accordance with the manufacturer's instructions.
  measure: Osteoprotegerin (OPG) level (ng/mL)
  time frame: 6 months
  description: All PICF samples were collected before clinical measurements. During sample collection, the implants were isolated using cotton rolls and dried gently with an air freshener, and paper strips were advanced into the pocket until resistance was felt. The paper strips were kept in the peri-implant pocket for 30 sec. Paper strips were placed in 500-µL sterilized Eppendorf® tubes to which phosphate-buffered saline (PBS) was added. All samples were kept at -40° until analysis. The enzyme-linked immunosorbent assay (ELISA) was used to measure OPG levels in the PICF samples in accordance with the manufacturer's instructions.
  measure: Plaque index score (0-3)
  time frame: 6 months
  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
  measure: Gingival index score (0-3)
  time frame: 6 months
  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 index 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
  measure: Bleeding on probing (percentage)
  time frame: 6 months
  description: Bleeding on probing was measured 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.
  arm group label: Non-surgical mechanical therapy
  arm group type: Active Comparator
  description: Titanium curettes were used for non-surgical mechanical therapy in both groups under local anesthesia. The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt. The control group received mechanical therapy alone.
  arm group label: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
  arm group type: Active Comparator
  description: Titanium curettes were used for non-surgical mechanical therapy in both groups under local anesthesia. The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt. The laser group received mechanical therapy followed by Er;Cr;YSGG laser.
  intervention type: Device
  intervention name: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
  description: The laser group received mechanical therapy followed by Er;Cr;YSGG laser. Laser application was performed using the bottom-up technique. Therefore, the tip was retracted about 1 mm after it was placed on the bottom of the pocket and slowly moved in the coronal direction to the parallel to the implant surface.
  arm group label: Er, Cr: YSGG laser-assisted non-surgical mechanical therapy
  intervention type: Device
  intervention name: Non-surgical mechanical therapy
  description: Traditional non surgical mechanical therapy Mechanical instrumentation in all groups was made with titanium curettes.The curette was gently inserted into the peri-implant pocket and the mechanical therapy was completed with threads felt.
  arm group label: Non-surgical mechanical therapy
  criteria: 
  gender: All
  minimum age: 28 Years
  maximum age: 63 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nazli Zeynep Alpaslan, PhD
  role: Principal Investigator
  affiliation: Van Yuzuncu Yil University
  last name: Dicle Altindal, PhD
  role: Study Chair
  affiliation: Van Yuzuncu Yil University
  last name: Damla Akbal, PhD
  role: Study Chair
  affiliation: Private Dental Clinic
  last name: Ahmet Cemil Talmac, PhD
  role: Study Chair
  affiliation: Van Yuzuncu Yil University
  last name: Serap Keskin Tunc, PhD
  role: Study Chair
  affiliation: Saglik Bilimleri Universitesi
  last name: Abdullah Seckin Ertugrul, PhD
  role: Study Chair
  affiliation: Izmir Katip Celebi University
  facility: 
  country: Turkey
  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.
  PMID: 34637055
  responsible party type: Principal Investigator
  investigator affiliation: Yuzuncu Yıl University
  investigator full name: Nazli Zeynep Alpaslan
  investigator title: DDS, PhD, Assoc. Prof. Dr
  mesh term: Peri-Implantitis
  sharing ipd: No