<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/NCT02215460</url>
  </required_header>
  <id_info>
    <org_study_id>FMSQSPT</org_study_id>
    <secondary_id>CEP521/10</secondary_id>
    <secondary_id>2010/19079-8</secondary_id>
    <nct_id>NCT02215460</nct_id>
  </id_info>
  <brief_title>Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours</brief_title>
  <official_title>Effectiveness of Two Non-surgical Periodontal Treatment Protocols: Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Taubate</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Taubate</source>
  <brief_summary>
    <textblock>
      Periodontitis is a form of gum disease that affects many people in the world. Its traditional&#xD;
      protocol of treatment includes oral hygiene instruction and dental scaling to remove debris,&#xD;
      dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option&#xD;
      also usually cheaper. In this last one, all above described procedures are performed within&#xD;
      24 hours. However, up to now comparative effectiveness between these both types of treatment&#xD;
      is not well understood. For, example it is not clear if patients treated in the shorter-time&#xD;
      experienced more pain. Therefore, the present study used several parameters to clarify&#xD;
      whether beneficial differences between these therapeutic protocols exist or not. In addition,&#xD;
      aspects that could help clinicians' and patient's decisions such as experience of pain and&#xD;
      anxiety related to dental treatment were also investigated. After receiving verbal and&#xD;
      written explanations and signed the informed consent form 150 individuals (n=15/group) having&#xD;
      the most common type of periodontitis in adults were randomly allocated to be treated in 4&#xD;
      weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were&#xD;
      performed alone or in conjunction with antimicrobial agents: a mouth rinse containing&#xD;
      chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at&#xD;
      baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral&#xD;
      debris and malodor; quantification of bacteria in plaque samples collected with paper points&#xD;
      from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect&#xD;
      information about oral condition, daily activities, pain and anxiety related to dental&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvements in pocket depth and clinical attachment level measurements</measure>
    <time_frame>Changes in pocket depth and clinical attachment level measurements from baseline to 6 months</time_frame>
    <description>Primary outcomes of effectiveness were improvements of the following clinical parameters: periodontal pocket depth (mm) and clinical attachment level (mm) from baseline to 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvements in plaque index and gingival index</measure>
    <time_frame>Changes from baseline to 3 months</time_frame>
    <description>Improvements in plaque index (scores) and gingival index (scores) when baseline data was compared to 3 months data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance of pocket depth and clinical attachment level measurements</measure>
    <time_frame>Changes in pocket depth and clinical attachment level from 6 months to 9 months</time_frame>
    <description>Pocket depth (mm) and clinical attachment level (mm) values observed at 6 were compared to those observed at 9 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in total bacterial load and levels of selected pathogens</measure>
    <time_frame>3 months</time_frame>
    <description>Reductions in total bacterial load and levels of selected pathogens were determined by real time PCR (polymerase chain reaction) in samples from periodontal pockets and dorsal tongue. Values between baseline and 3 months were compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines</measure>
    <time_frame>3 months</time_frame>
    <description>Possible reductions in gingival crevicular fluid volume and in concentrations of tumor necrosis factor alfa (TNFα) and interleukin 1 beta (IL-1β) were measured by comparing values between baseline and 3 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Impact of periodontal treatment on quality of life</measure>
    <time_frame>6 and 9 months</time_frame>
    <description>The expected positive effect of periodontal treatment on quality of life (score) was measured by comparing baseline data and data collected at 6 and 9 months after therapy</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of periodontal disease on quality of life</measure>
    <time_frame>Baseline</time_frame>
    <description>The expected negative effect of periodontal disease on quality of life (score) was measured by analyzing baseline data.</description>
  </other_outcome>
  <other_outcome>
    <measure>Dental Anxiety experience</measure>
    <time_frame>Baseline</time_frame>
    <description>Dental Anxiety (score) was measured immediately before treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Experience of pain</measure>
    <time_frame>at the second day for full-mouth scaling groups; or at month for quadrant scaling groups.</time_frame>
    <description>Experience of pain (scale) due to type of scaling was evaluated immediately after treatment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in nitrite levels</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in nitrite levels (mean values) in saliva was determined by comparing baseline and 6 months values.</description>
  </other_outcome>
  <other_outcome>
    <measure>Improvements in organoleptic and volatile sulphur compounds measurements</measure>
    <time_frame>3 months</time_frame>
    <description>The expected positive impact of periodontal treatment on organoleptic (score) and volatile sulphur compounds (mean values) measurements were evaluated at 3 months.</description>
  </other_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Full-mouth scaling (FMS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FMS chlorhexidine rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FMS azithromycin tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FMS placebo rinse</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadrant scaling (QS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QS chlorhexidine rinse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QS azithromycin tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QS placebo tablets</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FMS placebo tablets</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>QS placebo rinse</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>FMS full-mouth scaling</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling within 24 hours. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>FMS azithromycin tablets</arm_group_label>
    <arm_group_label>FMS chlorhexidine rinse</arm_group_label>
    <arm_group_label>FMS placebo rinse</arm_group_label>
    <arm_group_label>FMS placebo tablets</arm_group_label>
    <arm_group_label>Full-mouth scaling (FMS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>QS quadrant scaling</intervention_name>
    <description>Participants received oral hygiene instructions and quadrant scaling in 4 weekly sections. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>QS azithromycin tablets</arm_group_label>
    <arm_group_label>QS chlorhexidine rinse</arm_group_label>
    <arm_group_label>QS placebo rinse</arm_group_label>
    <arm_group_label>QS placebo tablets</arm_group_label>
    <arm_group_label>Quadrant scaling (QS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FMS chlorhexidine rinse</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>FMS chlorhexidine rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FMS placebo rinse</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of placebo mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>FMS placebo rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FMS azithromycin tablets</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>FMS azithromycin tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FMS placebo tablets</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>FMS placebo tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QS azithromycin tablets</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>QS azithromycin tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QS placebo tablets</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>QS placebo tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QS chlorhexidine rinse</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>QS chlorhexidine rinse</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QS placebo rinse</intervention_name>
    <description>Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% placebo mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.</description>
    <arm_group_label>QS placebo rinse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild to moderate chronic periodontitis;&#xD;
&#xD;
          -  at least 20 natural teeth;&#xD;
&#xD;
          -  good general health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemic diseases or other conditions that could influence the periodontal status;&#xD;
&#xD;
          -  events of high blood pressure or diagnosed hypertension;&#xD;
&#xD;
          -  alcohol abuse;&#xD;
&#xD;
          -  orthodontic devices;&#xD;
&#xD;
          -  extended prosthetic fixed devices, removable partial dentures or overhanging&#xD;
             restorations;&#xD;
&#xD;
          -  pregnancy or breast-feeding;&#xD;
&#xD;
          -  history of sensitivity or suspected allergies following the use of oral hygiene&#xD;
             products and/or the test antibiotic;&#xD;
&#xD;
          -  the need for antibiotic prophylaxis;&#xD;
&#xD;
          -  antibiotics and/or anti-inflammatory drug use in the three months prior to the&#xD;
             beginning of the study;&#xD;
&#xD;
          -  regular use of chemotherapeutic antiplaque/antigingivitis products;&#xD;
&#xD;
          -  any furcation lesions;&#xD;
&#xD;
          -  periodontal treatment performed within six months prior to study initiation;&#xD;
&#xD;
          -  unwillingness to return for follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nucleus of periodontal research of University of Taubate</name>
      <address>
        <city>Taubate</city>
        <state>SP</state>
        <zip>12020330</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Cortelli JR, CASTRO MVM; BALEJO RDP, ALENCAR CO, GARGIONI AC, CORTELLI SC, COSTA FO. Clinical and microbiological evaluation of one-stage full-mouth disinfection: a short-term study. Revista de Odontologia da UNESP (Online), v. 42, p. 298-303, 2013. DOI: doi.org/10.1590/S1807-25772013000400010.</citation>
  </results_reference>
  <results_reference>
    <citation>CORTELLI JR. et al. Clinical/Microbiological Comparative Effects between Full-mouth and Quadrant Debridement plus Chlorhexidine. In: IADR, 2013, SEATTLE. IADR, 2013.</citation>
  </results_reference>
  <results_reference>
    <citation>CORTELLI JR, COSTA FO, ALENCAR CO, CASTRO MVM, GARGIONI AC, AQUINO DR, CORTELLI SC. CLINICAL EFFECTS OF FULL MOUTH OR QUADRANT DEBRIDEMENT WITH CHLOREXIDINA OR AZITROMYCIN. In: IADR-ASIA PACIFIC REGION, 2013, BANGKOK. IADR-APR, 2013. v. 1. p. 158-158.</citation>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Azithromycin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02215460
org study id: FMSQSPT
secondary id: CEP521/10
secondary id: 2010/19079-8
nct id: NCT02215460
lead sponsor: 
collaborator: 
Periodontitis is a form of gum disease that affects many people in the world. Its traditional
      protocol of treatment includes oral hygiene instruction and dental scaling to remove debris,
      dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option
      also usually cheaper. In this last one, all above described procedures are performed within
      24 hours. However, up to now comparative effectiveness between these both types of treatment
      is not well understood. For, example it is not clear if patients treated in the shorter-time
      experienced more pain. Therefore, the present study used several parameters to clarify
      whether beneficial differences between these therapeutic protocols exist or not. In addition,
      aspects that could help clinicians' and patient's decisions such as experience of pain and
      anxiety related to dental treatment were also investigated. After receiving verbal and
      written explanations and signed the informed consent form 150 individuals (n=15/group) having
      the most common type of periodontitis in adults were randomly allocated to be treated in 4
      weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were
      performed alone or in conjunction with antimicrobial agents: a mouth rinse containing
      chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at
      baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral
      debris and malodor; quantification of bacteria in plaque samples collected with paper points
      from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect
      information about oral condition, daily activities, pain and anxiety related to dental
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Improvements in pocket depth and clinical attachment level measurements
time frame: Changes in pocket depth and clinical attachment level measurements from baseline to 6 months
description: Primary outcomes of effectiveness were improvements of the following clinical parameters: periodontal pocket depth (mm) and clinical attachment level (mm) from baseline to 6 months.
measure: Improvements in plaque index and gingival index
time frame: Changes from baseline to 3 months
description: Improvements in plaque index (scores) and gingival index (scores) when baseline data was compared to 3 months data.
measure: Maintenance of pocket depth and clinical attachment level measurements
time frame: Changes in pocket depth and clinical attachment level from 6 months to 9 months
description: Pocket depth (mm) and clinical attachment level (mm) values observed at 6 were compared to those observed at 9 months.
measure: Changes in total bacterial load and levels of selected pathogens
time frame: 3 months
description: Reductions in total bacterial load and levels of selected pathogens were determined by real time PCR (polymerase chain reaction) in samples from periodontal pockets and dorsal tongue. Values between baseline and 3 months were compared.
measure: Changes in volume of gingival crevicular fluid and levels of pro-inflammatory cytokines
time frame: 3 months
description: Possible reductions in gingival crevicular fluid volume and in concentrations of tumor necrosis factor alfa (TNFα) and interleukin 1 beta (IL-1β) were measured by comparing values between baseline and 3 months.
measure: Impact of periodontal treatment on quality of life
time frame: 6 and 9 months
description: The expected positive effect of periodontal treatment on quality of life (score) was measured by comparing baseline data and data collected at 6 and 9 months after therapy
measure: Impact of periodontal disease on quality of life
time frame: Baseline
description: The expected negative effect of periodontal disease on quality of life (score) was measured by analyzing baseline data.
measure: Dental Anxiety experience
time frame: Baseline
description: Dental Anxiety (score) was measured immediately before treatment.
measure: Experience of pain
time frame: at the second day for full-mouth scaling groups; or at month for quadrant scaling groups.
description: Experience of pain (scale) due to type of scaling was evaluated immediately after treatment.
measure: Changes in nitrite levels
time frame: 6 months
description: Changes in nitrite levels (mean values) in saliva was determined by comparing baseline and 6 months values.
measure: Improvements in organoleptic and volatile sulphur compounds measurements
time frame: 3 months
description: The expected positive impact of periodontal treatment on organoleptic (score) and volatile sulphur compounds (mean values) measurements were evaluated at 3 months.
arm group label: Full-mouth scaling (FMS)
arm group type: Experimental
arm group label: FMS chlorhexidine rinse
arm group type: Experimental
arm group label: FMS azithromycin tablets
arm group type: Experimental
arm group label: FMS placebo rinse
arm group type: Placebo Comparator
arm group label: Quadrant scaling (QS)
arm group type: Experimental
arm group label: QS chlorhexidine rinse
arm group type: Experimental
arm group label: QS azithromycin tablets
arm group type: Experimental
arm group label: QS placebo tablets
arm group type: Placebo Comparator
arm group label: FMS placebo tablets
arm group type: Placebo Comparator
arm group label: QS placebo rinse
arm group type: Placebo Comparator
intervention type: Procedure
intervention name: FMS full-mouth scaling
description: Participants received oral hygiene instructions and full-mouth scaling within 24 hours. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: FMS azithromycin tablets
arm group label: FMS chlorhexidine rinse
arm group label: FMS placebo rinse
arm group label: FMS placebo tablets
arm group label: Full-mouth scaling (FMS)
intervention type: Procedure
intervention name: QS quadrant scaling
description: Participants received oral hygiene instructions and quadrant scaling in 4 weekly sections. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: QS azithromycin tablets
arm group label: QS chlorhexidine rinse
arm group label: QS placebo rinse
arm group label: QS placebo tablets
arm group label: Quadrant scaling (QS)
intervention type: Drug
intervention name: FMS chlorhexidine rinse
description: Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: FMS chlorhexidine rinse
intervention type: Drug
intervention name: FMS placebo rinse
description: Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of placebo mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: FMS placebo rinse
intervention type: Drug
intervention name: FMS azithromycin tablets
description: Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: FMS azithromycin tablets
intervention type: Drug
intervention name: FMS placebo tablets
description: Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: FMS placebo tablets
intervention type: Drug
intervention name: QS azithromycin tablets
description: Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: QS azithromycin tablets
intervention type: Drug
intervention name: QS placebo tablets
description: Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: QS placebo tablets
intervention type: Drug
intervention name: QS chlorhexidine rinse
description: Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: QS chlorhexidine rinse
intervention type: Drug
intervention name: QS placebo rinse
description: Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% placebo mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
arm group label: QS placebo rinse
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Brazil
citation: Cortelli JR, CASTRO MVM; BALEJO RDP, ALENCAR CO, GARGIONI AC, CORTELLI SC, COSTA FO. Clinical and microbiological evaluation of one-stage full-mouth disinfection: a short-term study. Revista de Odontologia da UNESP (Online), v. 42, p. 298-303, 2013. DOI: doi.org/10.1590/S1807-25772013000400010.
citation: CORTELLI JR. et al. Clinical/Microbiological Comparative Effects between Full-mouth and Quadrant Debridement plus Chlorhexidine. In: IADR, 2013, SEATTLE. IADR, 2013.
citation: CORTELLI JR, COSTA FO, ALENCAR CO, CASTRO MVM, GARGIONI AC, AQUINO DR, CORTELLI SC. CLINICAL EFFECTS OF FULL MOUTH OR QUADRANT DEBRIDEMENT WITH CHLOREXIDINA OR AZITROMYCIN. In: IADR-ASIA PACIFIC REGION, 2013, BANGKOK. IADR-APR, 2013. v. 1. p. 158-158.
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Azithromycin