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/NCT05964699</url>
    </required_header>
    <id_info>
      <org_study_id>IRB2022-1175-CD-DCR</org_study_id>
      <nct_id>NCT05964699</nct_id>
    </id_info>
    <brief_title>The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP</brief_title>
    <official_title>The Use of a Non-Incised Minimally Invasive Flap Procedure in Conjunction With Emdogain® MI Compared to Traditional SRCP</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Texas A&amp;M University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut Straumann AG</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Texas A&amp;M University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is designed to evaluate the use of Emdogain® MI in a procedure where a significant&#xD;
        portion of the lining of the sulcus is removed by curettage (similar to the traditional&#xD;
        clinical procedure described as &quot;gingival curettage&quot;) to the point of tissue mobility. This&#xD;
        will be designated as a &quot;non-incised minimally invasive flap access procedure&quot;. A videoscope&#xD;
        will be utilized to assist with the requirement to adequately visualize and debride the root&#xD;
        surface. This research project will define the approach used as a &quot;non-incised minimally&#xD;
        invasive flap access&quot; approach and will be a modification of recognized minimally invasive&#xD;
        techniques. This modification will be made by Dr. Harrel who first describe the minimally&#xD;
        invasive periodontal approach and defined minimally invasive periodontal procedures in 1995.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of a non-incised minimally invasive flap procedure in conjunction with Emdogain MI&#xD;
        compared to traditional scaling and root planing.&#xD;
  &#xD;
        Background&#xD;
  &#xD;
        The product Emdogain® MI is designed for use in a minimally invasive approach to periodontal&#xD;
        treatment. This product is being marketed for what is termed a &quot;flapless&quot; procedure whereby&#xD;
        scaling and root planing (SRP) is performed, the root surface is &quot;visualized&quot;, debrided, and&#xD;
        conditioned with EDTA (PrefGel), and then Emdogain® MI is inserted between the root surface&#xD;
        and the sulcus tissue to reduce inflammation and stimulate reattachment.&#xD;
  &#xD;
        The approach described above has met with mixed success. The concerns are associated with&#xD;
        difficulty in the visualization of the sulcus and the difficulty in removing root accretions&#xD;
        (calculus) with the &quot;flapless&quot; approach.&#xD;
  &#xD;
        Purpose&#xD;
  &#xD;
        This study is designed to evaluate the use of Emdogain® MI in a procedure where a significant&#xD;
        portion of the lining of the sulcus is removed by curettage (similar to the traditional&#xD;
        clinical procedure described as &quot;gingival curettage&quot;) to the point of tissue mobility. This&#xD;
        will be designated as a &quot;non-incised minimally invasive flap access procedure&quot;. A videoscope&#xD;
        will be utilized to assist with the requirement to adequately visualize and debride the root&#xD;
        surface. This research project will define the approach used as a &quot;non-incised minimally&#xD;
        invasive flap access&quot; approach and will be a modification of recognized minimally invasive&#xD;
        techniques. This modification will be made by Dr. Harrel who first describe the minimally&#xD;
        invasive periodontal approach and defined minimally invasive periodontal procedures in 1995.&#xD;
        Note: No portion of this research will be utilized for a new or modified FDA application.&#xD;
  &#xD;
        This study is being performed to assess if the use of Emdogain® MI in conjunction with SRP&#xD;
        and videoscope visualization can provide better treatment outcomes, resulting in the&#xD;
        improvement of periodontal clinical parameters when compared to traditional SRP and&#xD;
        videoscope visualization without the use of Emdogain® MI.&#xD;
  &#xD;
        Rational of the study&#xD;
  &#xD;
        Hypothesis - To demonstrate that Emdogain® MI applied to an adequately visualized and&#xD;
        debrided root surface using a non-incised minimally invasive flap access procedure will&#xD;
        result in improvement of periodontal clinical parameters when compared to traditional SRP&#xD;
        without the use of Emdogain® MI.&#xD;
  &#xD;
        Primary End Point&#xD;
  &#xD;
        Report the amount of improvement in clinical markers (PD, CAL, recession/keratinized tissue,&#xD;
        BOP, PI) following non-incised minimally invasive flap periodontal procedures performed with&#xD;
        direct videoscope visualization and root debridement followed by the application of Emdogain®&#xD;
        MI compared to SRP without the use of Emdogain® MI.&#xD;
  &#xD;
        Secondary End Points&#xD;
  &#xD;
        Report the time necessary to perform the test procedures, compare the patient perception of&#xD;
        the test and control procedures such as immediate post-treatment discomfort and impact on&#xD;
        life activities, and report the patient perception of long-term post-treatment function and&#xD;
        esthetics.&#xD;
  &#xD;
        Indication&#xD;
  &#xD;
        The non-incised minimally invasive flap procedure is indicated for isolated defects on teeth&#xD;
        located in esthetic areas that initially present with moderate pocket depth and minimal&#xD;
        radiographic detectable bone loss. In routine/traditional clinical practice, these isolated&#xD;
        more advanced defects will often be treated by non-surgical/non-regenerative procedures i.e.&#xD;
        scaling and root planing, only. The use of SRP only will frequently result in less than a&#xD;
        complete resolution of the periodontal defect. The proposed non-incised minimally invasive&#xD;
        flap procedure will be indicated and performed as an adjunct for isolated deeper pockets&#xD;
        encountered during routine quadrant SRP.&#xD;
  &#xD;
        Materials and Methods&#xD;
  &#xD;
        This will be a single masked clinical outcomes study. Ethical approval will be obtained from&#xD;
        the Texas A&amp;M University IRB and study ethical standards and registration will follow the&#xD;
        IRB's established guidelines.&#xD;
  &#xD;
        Patients will be selected from patients presenting for routine periodontal treatment at Texas&#xD;
        A&amp;M University College of Dentistry department of Periodontology. Prior to entering the&#xD;
        study, patients will have radiographs and periodontal charting performed. Based on the&#xD;
        pre-study evaluation and radiographs, patients will be treatment planned for non-surgical&#xD;
        (SCRP) periodontal treatment as initial therapy. A review of the initial records will&#xD;
        determine potential candidates for this study. The study teeth will be limited to bicuspid&#xD;
        and cuspid teeth. To be included in the study, patients will present with generalized&#xD;
        periodontitis with isolated pockets depths of 5 to &lt;7 mm on bicuspid and cuspid teeth, no&#xD;
        more than 1 mm of radiographic bone loss apparent on study teeth, and at least 2 mm of&#xD;
        attachment loss. To qualify for the study there will need to be two similar teeth in a single&#xD;
        patient meeting the criteria for isolated pockets in two separate quadrants. One site will be&#xD;
        randomly assigned as a test site (non-incised minimally invasive flap procedure with&#xD;
        Emdogain® MI) and the other will be assigned as the control site (SRP and Videoscope only).&#xD;
  &#xD;
        Test and control site breakdown:&#xD;
  &#xD;
          -  Standard deep cleaning (SRP) on all teeth in one quadrant and the use of a small camera&#xD;
             (Videoscope) on one tooth on that side (control tooth).&#xD;
  &#xD;
          -  On the other quadrant you will receive a standard deep cleaning (SRP) of all teeth in&#xD;
             that quadrant and the use of a small camera called a videoscope and the protein gel&#xD;
             which is what we call the closed access procedure on one tooth (research / test tooth).&#xD;
  &#xD;
        Inclusion criteria will be patients between 30 and 75 years of age, in general good health&#xD;
        (ASA I or II), smoke less than 10 cigarettes or equivalent per day, have no antibiotics for&#xD;
        the past 90 days, and not taking medications that are known to inhibit or slow healing.&#xD;
        Exclusion criteria will be pregnant or lactating patients, active periodontal treatment in&#xD;
        the last 6 months, smokers of greater than 10 cigarettes per day, and patients with serious&#xD;
        medical conditions.&#xD;
  &#xD;
        On the day of treatment, a calibrated blinded evaluator will record all clinical parameters&#xD;
        for the test and control teeth. These will include oral hygiene level, BOP, PD, CAL,&#xD;
        keratinized gingival width, and standardized photographs. Radiographs will be taken of the&#xD;
        test and control sites. All patients will be administered adequate local anesthetic for pain&#xD;
        control in the areas to be treated. The operator will not be informed at this point as to the&#xD;
        control and test teeth. All sites will have SRP performed utilizing the videoscope for&#xD;
        intersulcular root visualization. The endpoint of SCRP will be when the therapist can not see&#xD;
        or feel any calculus (tartar) or roughness on the root surface. Within the routine clinical&#xD;
        limits of SCRP, the sulcus may be curetted and the soft tissue removed to the point that the&#xD;
        clinician feels there is adequate access for evaluation and debridement of the root surface.&#xD;
        At that point, the designated oral sites will be revealed to the treating therapist as having&#xD;
        been designated to test or control by random assignment.&#xD;
  &#xD;
        No further treatment will be performed on the control site with the exception of placing&#xD;
        saline solution in the control site in a manner mimicking the use of Emdogain® MI in the test&#xD;
        site. In the test sites, the sulcus will be curetted to the point that the tissue surrounding&#xD;
        the teeth becomes moveable with gentle finger pressure. The curettage will be performed using&#xD;
        routine periodontal curettes designed for sulcular curettage. No incisions will be made. When&#xD;
        the tissue is moveable, the test site will be described as having non-incised minimally&#xD;
        invasive flap access. The &quot;flap&quot; designation will be made because the tissue is moveable as&#xD;
        is the case with traditional &quot;flap&quot; procedures. Further visualization of the root surface&#xD;
        will be performed using the videoscope and, as necessary, the root on the test and control&#xD;
        tooth will be further debrided of all remaining visible calculus and roughness. It will be&#xD;
        recorded if there is or is not further material to be removed i.e. if there is material&#xD;
        remaining after routine SCRP. Neutral EDTA (PrefGel) will be used to condition the root&#xD;
        surface and Emdogain® MI applied to the test tooth following the manufacturers' instructions.&#xD;
        In both control and test sites, the tissue will only be stabilized post-treatment by applying&#xD;
        finger pressure. No sutures will be used. The time necessary to complete the additional&#xD;
        procedures (beyond SCRP) on the test tooth will be recorded.&#xD;
  &#xD;
        Patients will be seen for postoperative evaluation at one week, 3 months, and 6 months. The&#xD;
        dental cleanings (gum maintenances / periodontal maintenance) and follow-up visits are part&#xD;
        of standard of care and are not for research-only purposes. Patients who undergo deep&#xD;
        cleaning should have their maintenance appointments (gum maintenances) every 3 months as part&#xD;
        of standard of care.&#xD;
  &#xD;
        Oral hygiene will be reinforced and photographs made at the one-week visit but no clinical&#xD;
        measurements will be made. Clinical parameters will be measured and recorded by a calibrated&#xD;
        blinded evaluator at the 3 and 6-month evaluation followed by a routine periodontal&#xD;
        maintenance procedure. A radiograph using paralleling technique will be obtained prior to&#xD;
        treatment and at the 6-month postsurgical evaluation. All patients will be asked to fill out&#xD;
        a VAS pain scale for the test and control areas the evening following the procedure and at&#xD;
        each post-surgical evaluation appointment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 31, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>Split mouth study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Participants, investigators, and outcome assessors are unaware of the assigned interventions. The care provider will know at this time of procedure what site will receive the intervention and what site will be the control site.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Attachment level change.</measure>
      <time_frame>The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination.</time_frame>
      <description>Attachment change will be determined by measuring clinical probing depth and gingival marginal level with an UNC probe. The clinical attachment level is the distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing depth change.</measure>
      <time_frame>Probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.</time_frame>
      <description>Probing depth change will be determined with an UNC probe during clinical examination on the control and test sites. Probing depth will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Probing depth is the distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gingival margin level / recession change.</measure>
      <time_frame>Gingival margin level / recession level change will be determined from baseline to the 3 month follow-up and 6 month follow-up.</time_frame>
      <description>Gingival margin level / recession will be determined with an UNC probe during clinical examination on the control and test sites. Gingival margin level / recession will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. The migration of the marginal soft tissue to a point apical to the cemento-enamel junction of a tooth or the platform of a dental implant is defined as recession.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bleeding on probing change.</measure>
      <time_frame>The bleeding of probing change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.</time_frame>
      <description>Bleeding on probing will be determined with an UNC probe during clinical examination on the control and test sites. Bleeding of probing sites will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Bleeding on probing happens when induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biofilm presence change.</measure>
      <time_frame>Biofilm presence change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.</time_frame>
      <description>Biofilm presence will be determined with an UNC probe during clinical examination on the control and test sites. Biofilm will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Dental plaque is the prototypical example of a biofilm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time necessary to perform the test procedures</measure>
      <time_frame>1 day (Time necessary to perform the test procedure at the initial appointment.)</time_frame>
      <description>Report the time necessary to perform the test procedures - non-incised minimally invasive flap procedure in conjunction with Emdogain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS pain scale 24 hours after appointment.</measure>
      <time_frame>24 hour follow-up.</time_frame>
      <description>VAS pain scale for the test and control areas the following the procedure at 24 hours after appointment. The VAS scale is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAS pain scale 1 week after appointment.</measure>
      <time_frame>1 week following the procedure.</time_frame>
      <description>VAS pain scale for the test and control areas 1 week following the procedure. The VAS scale is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">32</enrollment>
    <condition>Periodontitis</condition>
    <condition>Attachment Loss, Periodontal</condition>
    <arm_group>
      <arm_group_label>Periodontal regeneration</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Minimally invasive periodontal therapy with use of Emdogain</intervention_name>
      <description>Scaling of root with assisted use of the Videoscope and regrowth of attachment by the use of Emdogain.</description>
      <arm_group_label>Periodontal regeneration</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Minimally invasive periodontal therapy without the use of Emdogain</intervention_name>
      <description>Scaling of root with assisted use of the Videoscope.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          To participate in this study, you must present:&#xD;
  &#xD;
            -  Generalized gum disease with isolated pocket depths of 5 mm to less than 7 mm on&#xD;
               bicuspid and cuspid teeth.&#xD;
  &#xD;
            -  At least 2 mm of attachment loss.&#xD;
  &#xD;
            -  Need to have two similar teeth meeting the criteria for isolated pockets on two other&#xD;
               quadrants of the mouth.&#xD;
  &#xD;
            -  Need to be between 30 and 75 years of age.&#xD;
  &#xD;
            -  Be in good health.&#xD;
  &#xD;
            -  Smoke less than 10 cigarettes or equivalent per day.&#xD;
  &#xD;
            -  No antibiotics for the past 90 days.&#xD;
  &#xD;
            -  Not be taking medications that are known to inhibit or slow healing.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          You are not eligible if:&#xD;
  &#xD;
            -  You are pregnant.&#xD;
  &#xD;
            -  You are breast feeding.&#xD;
  &#xD;
            -  Received gum treatment in the last 6 months.&#xD;
  &#xD;
            -  Smoke more than ten cigarettes per day.&#xD;
  &#xD;
            -  You have any serious medical conditions.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Daniel Patrick O Ryan, DDS</last_name>
      <phone>2143642857</phone>
      <email>dryan@tamu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carlos Parra, DDS</last_name>
      <phone>6179716788</phone>
      <email>cparra@tamu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Texas A&amp;M School of Dentistry</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75246</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniel Patrick O Ryan, DDS</last_name>
        <phone>214-364-2857</phone>
        <email>dryan@tamu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</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>
      <mesh_term>Periodontal Attachment Loss</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/NCT05964699
  org study id: IRB2022-1175-CD-DCR
  nct id: NCT05964699
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study is designed to evaluate the use of Emdogain® MI in a procedure where a significant
        portion of the lining of the sulcus is removed by curettage (similar to the traditional
        clinical procedure described as "gingival curettage") to the point of tissue mobility. This
        will be designated as a "non-incised minimally invasive flap access procedure". A videoscope
        will be utilized to assist with the requirement to adequately visualize and debride the root
        surface. This research project will define the approach used as a "non-incised minimally
        invasive flap access" approach and will be a modification of recognized minimally invasive
        techniques. This modification will be made by Dr. Harrel who first describe the minimally
        invasive periodontal approach and defined minimally invasive periodontal procedures in 1995.
  The use of a non-incised minimally invasive flap procedure in conjunction with Emdogain MI
        compared to traditional scaling and root planing.
  
        Background
  
        The product Emdogain® MI is designed for use in a minimally invasive approach to periodontal
        treatment. This product is being marketed for what is termed a "flapless" procedure whereby
        scaling and root planing (SRP) is performed, the root surface is "visualized", debrided, and
        conditioned with EDTA (PrefGel), and then Emdogain® MI is inserted between the root surface
        and the sulcus tissue to reduce inflammation and stimulate reattachment.
  
        The approach described above has met with mixed success. The concerns are associated with
        difficulty in the visualization of the sulcus and the difficulty in removing root accretions
        (calculus) with the "flapless" approach.
  
        Purpose
  
        This study is designed to evaluate the use of Emdogain® MI in a procedure where a significant
        portion of the lining of the sulcus is removed by curettage (similar to the traditional
        clinical procedure described as "gingival curettage") to the point of tissue mobility. This
        will be designated as a "non-incised minimally invasive flap access procedure". A videoscope
        will be utilized to assist with the requirement to adequately visualize and debride the root
        surface. This research project will define the approach used as a "non-incised minimally
        invasive flap access" approach and will be a modification of recognized minimally invasive
        techniques. This modification will be made by Dr. Harrel who first describe the minimally
        invasive periodontal approach and defined minimally invasive periodontal procedures in 1995.
        Note: No portion of this research will be utilized for a new or modified FDA application.
  
        This study is being performed to assess if the use of Emdogain® MI in conjunction with SRP
        and videoscope visualization can provide better treatment outcomes, resulting in the
        improvement of periodontal clinical parameters when compared to traditional SRP and
        videoscope visualization without the use of Emdogain® MI.
  
        Rational of the study
  
        Hypothesis - To demonstrate that Emdogain® MI applied to an adequately visualized and
        debrided root surface using a non-incised minimally invasive flap access procedure will
        result in improvement of periodontal clinical parameters when compared to traditional SRP
        without the use of Emdogain® MI.
  
        Primary End Point
  
        Report the amount of improvement in clinical markers (PD, CAL, recession/keratinized tissue,
        BOP, PI) following non-incised minimally invasive flap periodontal procedures performed with
        direct videoscope visualization and root debridement followed by the application of Emdogain®
        MI compared to SRP without the use of Emdogain® MI.
  
        Secondary End Points
  
        Report the time necessary to perform the test procedures, compare the patient perception of
        the test and control procedures such as immediate post-treatment discomfort and impact on
        life activities, and report the patient perception of long-term post-treatment function and
        esthetics.
  
        Indication
  
        The non-incised minimally invasive flap procedure is indicated for isolated defects on teeth
        located in esthetic areas that initially present with moderate pocket depth and minimal
        radiographic detectable bone loss. In routine/traditional clinical practice, these isolated
        more advanced defects will often be treated by non-surgical/non-regenerative procedures i.e.
        scaling and root planing, only. The use of SRP only will frequently result in less than a
        complete resolution of the periodontal defect. The proposed non-incised minimally invasive
        flap procedure will be indicated and performed as an adjunct for isolated deeper pockets
        encountered during routine quadrant SRP.
  
        Materials and Methods
  
        This will be a single masked clinical outcomes study. Ethical approval will be obtained from
        the Texas A&M University IRB and study ethical standards and registration will follow the
        IRB's established guidelines.
  
        Patients will be selected from patients presenting for routine periodontal treatment at Texas
        A&M University College of Dentistry department of Periodontology. Prior to entering the
        study, patients will have radiographs and periodontal charting performed. Based on the
        pre-study evaluation and radiographs, patients will be treatment planned for non-surgical
        (SCRP) periodontal treatment as initial therapy. A review of the initial records will
        determine potential candidates for this study. The study teeth will be limited to bicuspid
        and cuspid teeth. To be included in the study, patients will present with generalized
        periodontitis with isolated pockets depths of 5 to <7 mm on bicuspid and cuspid teeth, no
        more than 1 mm of radiographic bone loss apparent on study teeth, and at least 2 mm of
        attachment loss. To qualify for the study there will need to be two similar teeth in a single
        patient meeting the criteria for isolated pockets in two separate quadrants. One site will be
        randomly assigned as a test site (non-incised minimally invasive flap procedure with
        Emdogain® MI) and the other will be assigned as the control site (SRP and Videoscope only).
  
        Test and control site breakdown:
  
          -  Standard deep cleaning (SRP) on all teeth in one quadrant and the use of a small camera
             (Videoscope) on one tooth on that side (control tooth).
  
          -  On the other quadrant you will receive a standard deep cleaning (SRP) of all teeth in
             that quadrant and the use of a small camera called a videoscope and the protein gel
             which is what we call the closed access procedure on one tooth (research / test tooth).
  
        Inclusion criteria will be patients between 30 and 75 years of age, in general good health
        (ASA I or II), smoke less than 10 cigarettes or equivalent per day, have no antibiotics for
        the past 90 days, and not taking medications that are known to inhibit or slow healing.
        Exclusion criteria will be pregnant or lactating patients, active periodontal treatment in
        the last 6 months, smokers of greater than 10 cigarettes per day, and patients with serious
        medical conditions.
  
        On the day of treatment, a calibrated blinded evaluator will record all clinical parameters
        for the test and control teeth. These will include oral hygiene level, BOP, PD, CAL,
        keratinized gingival width, and standardized photographs. Radiographs will be taken of the
        test and control sites. All patients will be administered adequate local anesthetic for pain
        control in the areas to be treated. The operator will not be informed at this point as to the
        control and test teeth. All sites will have SRP performed utilizing the videoscope for
        intersulcular root visualization. The endpoint of SCRP will be when the therapist can not see
        or feel any calculus (tartar) or roughness on the root surface. Within the routine clinical
        limits of SCRP, the sulcus may be curetted and the soft tissue removed to the point that the
        clinician feels there is adequate access for evaluation and debridement of the root surface.
        At that point, the designated oral sites will be revealed to the treating therapist as having
        been designated to test or control by random assignment.
  
        No further treatment will be performed on the control site with the exception of placing
        saline solution in the control site in a manner mimicking the use of Emdogain® MI in the test
        site. In the test sites, the sulcus will be curetted to the point that the tissue surrounding
        the teeth becomes moveable with gentle finger pressure. The curettage will be performed using
        routine periodontal curettes designed for sulcular curettage. No incisions will be made. When
        the tissue is moveable, the test site will be described as having non-incised minimally
        invasive flap access. The "flap" designation will be made because the tissue is moveable as
        is the case with traditional "flap" procedures. Further visualization of the root surface
        will be performed using the videoscope and, as necessary, the root on the test and control
        tooth will be further debrided of all remaining visible calculus and roughness. It will be
        recorded if there is or is not further material to be removed i.e. if there is material
        remaining after routine SCRP. Neutral EDTA (PrefGel) will be used to condition the root
        surface and Emdogain® MI applied to the test tooth following the manufacturers' instructions.
        In both control and test sites, the tissue will only be stabilized post-treatment by applying
        finger pressure. No sutures will be used. The time necessary to complete the additional
        procedures (beyond SCRP) on the test tooth will be recorded.
  
        Patients will be seen for postoperative evaluation at one week, 3 months, and 6 months. The
        dental cleanings (gum maintenances / periodontal maintenance) and follow-up visits are part
        of standard of care and are not for research-only purposes. Patients who undergo deep
        cleaning should have their maintenance appointments (gum maintenances) every 3 months as part
        of standard of care.
  
        Oral hygiene will be reinforced and photographs made at the one-week visit but no clinical
        measurements will be made. Clinical parameters will be measured and recorded by a calibrated
        blinded evaluator at the 3 and 6-month evaluation followed by a routine periodontal
        maintenance procedure. A radiograph using paralleling technique will be obtained prior to
        treatment and at the 6-month postsurgical evaluation. All patients will be asked to fill out
        a VAS pain scale for the test and control areas the evening following the procedure and at
        each post-surgical evaluation appointment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Split mouth study
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Participants, investigators, and outcome assessors are unaware of the assigned interventions. The care provider will know at this time of procedure what site will receive the intervention and what site will be the control site.
  measure: Attachment level change.
  time frame: The attachment change will be determined from baseline to the 3 month follow-up and at the 6-month follow-up examination.
  description: Attachment change will be determined by measuring clinical probing depth and gingival marginal level with an UNC probe. The clinical attachment level is the distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing. The health of the attachment apparatus can affect the measurement.
  measure: Probing depth change.
  time frame: Probing depth change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
  description: Probing depth change will be determined with an UNC probe during clinical examination on the control and test sites. Probing depth will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Probing depth is the distance from the soft tissue (gingiva or alveolar mucosa) margin to the tip of the periodontal probe.
  measure: Gingival margin level / recession change.
  time frame: Gingival margin level / recession level change will be determined from baseline to the 3 month follow-up and 6 month follow-up.
  description: Gingival margin level / recession will be determined with an UNC probe during clinical examination on the control and test sites. Gingival margin level / recession will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. The migration of the marginal soft tissue to a point apical to the cemento-enamel junction of a tooth or the platform of a dental implant is defined as recession.
  measure: Bleeding on probing change.
  time frame: The bleeding of probing change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.
  description: Bleeding on probing will be determined with an UNC probe during clinical examination on the control and test sites. Bleeding of probing sites will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Bleeding on probing happens when induced by gentle manipulation of the tissue at the depth of the gingival sulcus, or interface between the gingiva and a tooth.
  measure: Biofilm presence change.
  time frame: Biofilm presence change will be determined from the baseline to the 3 month follow-up and 6 month follow-up.
  description: Biofilm presence will be determined with an UNC probe during clinical examination on the control and test sites. Biofilm will be recorded on the periodontal examination chart at the initial visit, the 3-month and 6-month follow-up appointments. Dental plaque is the prototypical example of a biofilm.
  measure: Time necessary to perform the test procedures
  time frame: 1 day (Time necessary to perform the test procedure at the initial appointment.)
  description: Report the time necessary to perform the test procedures - non-incised minimally invasive flap procedure in conjunction with Emdogain.
  measure: VAS pain scale 24 hours after appointment.
  time frame: 24 hour follow-up.
  description: VAS pain scale for the test and control areas the following the procedure at 24 hours after appointment. The VAS scale is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
  measure: VAS pain scale 1 week after appointment.
  time frame: 1 week following the procedure.
  description: VAS pain scale for the test and control areas 1 week following the procedure. The VAS scale is a tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.
  arm group label: Periodontal regeneration
  arm group type: Experimental
  description: Regeneration will be attempted during root scaling and planing with the application of Emdogain and the use of a Videoscope.
  arm group label: Control
  arm group type: Placebo Comparator
  description: The control group will receive standard-of-care root scaling and planing without the application of Emdogain and the use of a Videoscope.
  intervention type: Procedure
  intervention name: Minimally invasive periodontal therapy with use of Emdogain
  description: Scaling of root with assisted use of the Videoscope and regrowth of attachment by the use of Emdogain.
  arm group label: Periodontal regeneration
  intervention type: Procedure
  intervention name: Minimally invasive periodontal therapy without the use of Emdogain
  description: Scaling of root with assisted use of the Videoscope.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Daniel Patrick O Ryan, DDS
  phone: 2143642857
  email: dryan@tamu.edu
  last name: Carlos Parra, DDS
  phone: 6179716788
  email: cparra@tamu.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Periodontitis
  mesh term: Periodontal Attachment Loss
  sharing ipd: No