<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/NCT04506827</url>
  </required_header>
  <id_info>
    <org_study_id>SinusAug</org_study_id>
    <nct_id>NCT04506827</nct_id>
  </id_info>
  <brief_title>RCT With 3 Different Biomaterials for Maxillary Sinus Lift</brief_title>
  <official_title>Maxillary Sinus Augmentation With Three Different Biomaterials: Histologic, Histomorphometric, Clinical and Patient Reported Outcomes From a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pisa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pisa</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Lateral maxillary sinus augmentation (MSA) is a predictable bone regeneration&#xD;
      technique in case of atrophy of the posterior-upper maxilla. Aimed at obtaining quantity and&#xD;
      quality of bone suitable for receiving osseointegrated implants, its success is largely due&#xD;
      to the skill of the surgeon, but also to the characteristics of the biomaterial used.&#xD;
&#xD;
      Methods: Twenty-four patients needing MSA were included in the study. The patients were&#xD;
      randomly allocated to 3 different groups: Anorganic Bovine Bone Mineral (ABBM) as control,&#xD;
      Tricalcium Phosphate (TCP) with or without hyaluronic acid (HA) as test groups. Nine months&#xD;
      after MSA bone biopsies were harvested for the histomorphometric analysis. Secondary outcomes&#xD;
      were mean bone gain, intraoperative and post-operative complications, implant insertion&#xD;
      torque, implant failure and patient related outcome measures (PROMs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The implant-prosthetic rehabilitation of the atrophic maxilla requires the creation of&#xD;
      sufficient volumetric quantity of bone, through regeneration techniques, necessary to&#xD;
      position the implants.&#xD;
&#xD;
      Maxillary sinus augmentation (MSA) is probably the most predictable and best performing&#xD;
      technique.&#xD;
&#xD;
      The present randomized controlled study aims to evaluate and compare, histomorphometrically&#xD;
      and clinically three different bone substitutes such as: ABBM, Tricalcium Phosphate (TCP)&#xD;
      with or without the addition of hyaluronic acid (HA) that were used for lateral MSA. This&#xD;
      study population will be followed until the 3rd year. This study describes histological&#xD;
      differences between the three groups at 9 months.&#xD;
&#xD;
      All the patients enrolled in the study received a session of oral hygiene and a periodontal&#xD;
      examination before the surgical procedure to obtain a more favorable oral environment for&#xD;
      wound healing. A CBCT was mandatory for all included cases to verify that the maxillary sinus&#xD;
      was clear and that the residual bone height was 3 mm or less. All the enrolled patients&#xD;
      received 2 gr. of amoxicillin and clavulanic acid (or 600 mg. of clindamycin for those who&#xD;
      were allergic to penicillins) as a pre-medication one-hour before surgery. All patients&#xD;
      rinsed for 1 minute with 0.2% chlorhexidine mouthwash (and twice a day for the following 3&#xD;
      weeks). Local anesthesia was administered, a mid-crestal incision with mesial and distal&#xD;
      release were performed to access the lateral bone wall of the maxillary sinus, subsequently,&#xD;
      ultrasound bone surgery (Piezosurgery ®, Carasco, Italy) with specific tips was used for the&#xD;
      bone window osteotomy (Figure 1-A). The Schneiderian membrane was reflected and lifted up&#xD;
      medially with flat sinus curettes. Once the sinus membrane was completely lifted a&#xD;
      bioabsorbable pericardium membrane (Smartbrane, Regedent AG, Zurich, Switzerland) was applied&#xD;
      to protect it (Figure 1-B). The randomization sealed envelopes were opened and the clinician&#xD;
      allocated the patients to one of the three experimental groups:&#xD;
&#xD;
        1. Control group that received Demineralized Bovine Bone Mineral (Bio-Oss Cancellous,&#xD;
           Geistlich, Wolhunsen, Switzerland);&#xD;
&#xD;
        2. Test group 1 that received TCP with particle size ranging from 250 to 1000 µm (Osopia,&#xD;
           Regedent, Zurich, Switzerland);&#xD;
&#xD;
        3. Test group 2 that received TCP as in test group1 plus crosslinked Hyaluronic Acid&#xD;
           (Hyadent BG, Regedent, Zurich, Switzerland) with a ratio 2 to 1.&#xD;
&#xD;
      the bony window was repositioned, stabilized and covered with a resorbable pericardium&#xD;
      membrane. Nine months after the MSA a CBCT analysis was required to evaluate the total bone&#xD;
      height gain.&#xD;
&#xD;
      Depending on the treatment plan, between one and three implants, bone level (BL) or tissue&#xD;
      level (TL), of two different manufacturers (Institut Straumann AG, Basel, Switzerland and&#xD;
      Sweden &amp; Martina, Due Carrare, Italy) were positioned. While preparing the osteotomy implant&#xD;
      site a bone biopsy was harvested using a trephine. The implant insertion torque was measured&#xD;
      in Ncm for each implant.&#xD;
&#xD;
      All patients were prescribed 1gr amoxicillin + clavulanic acid twice daily for 7 days (for&#xD;
      those who were allergic to penicillin 300mg clindamycin 3 times daily for 7 days) as&#xD;
      post-operative prophylaxis. All patients received 8mg of dexamethasone immediately after&#xD;
      surgery and 4 mg of dexamethasone per day were prescribed for the following 5 days.&#xD;
      Analgesics were prescribed (1gr paracetamol 3 times daily) according to patients' need. The&#xD;
      use of removable temporary restorations was not recommended during the healing period.&#xD;
&#xD;
      After an osseointegration period of 3 months, the implants were restored. The prosthetic&#xD;
      procedures were similar for all groups, impressions were taken with a polyether rubber&#xD;
      material (Impregum, Espe Dental AG, Seefeld, Germany) and a customized impression tray. Final&#xD;
      Zirconia screw-retained restorations were delivered after a period of 2/3 weeks, peri-apical&#xD;
      radiographs were taken and oral hygiene instructions were given to all participants in the&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 23, 2017</start_date>
  <completion_date type="Actual">December 14, 2019</completion_date>
  <primary_completion_date type="Actual">June 29, 2019</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>
    <intervention_model_description>Three groups of patients will be treated with 3 different graft materials</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The envelope with the group assignment will be opened by the surgeon at the time of surgery and the patient won't be informed.&#xD;
The clinician who registers clinical parameters won't be informed of the group allocation. The histologist will receive biopsies with a numeric code but without informations of the graft material used.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Histomorphometric parameters of the augmented bone (descriptive)</measure>
    <time_frame>9 months</time_frame>
    <description>Descriptive analysis of the specimen section at the microscope</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Histomorphometric parameters of the augmented bone (% of new bone, marrow, graft)</measure>
    <time_frame>9 months</time_frame>
    <description>Percentages of newly formed bone, marrow spaces and residual graft particles are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean bone gain measured at 9 months through CBCT evaluation</measure>
    <time_frame>9 months</time_frame>
    <description>radiographic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-operative</measure>
    <time_frame>During surgery</time_frame>
    <description>clinical evaluation (yes/no) of the presence or occurrence of: sinus membrane perforation, excessive bleeding, lateral sinus cortical bone fracture.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>one week</time_frame>
    <description>clinical evaluation (yes/no) of the presence or occurrence of:symptoms of acute sinusitis, swelling, suppuration, bleeding, trismus, hematoma, wound dehiscence, acute infections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>9 months</time_frame>
    <description>clinical evaluation (yes/no) of the presence or occurrence of:symptoms of chronic sinusitis, swelling, suppuration, wound dehiscence, acute infections.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implant insertion torque measured in Ncm</measure>
    <time_frame>9 months</time_frame>
    <description>clinical evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early implant failure</measure>
    <time_frame>12 months</time_frame>
    <description>clinical evaluation of the osseointegration of the implant into the bone (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported outcome measures</measure>
    <time_frame>9 months</time_frame>
    <description>All patients will answer a questionnaire regarding the oral health-related quality of life using the 14 questions of the short-form Oral Health Impact Profile (OHIP-14) (This questionnaire consists of 14 questions each one formulated in the following way: &quot;How often (impact item) because of problems with your teeth, mouth or dentures?&quot; The impact items belong to 7 different impact domains: 1. Functional limitations; 2. Physical pain; 3. Psychological discomfort; 4. Physical disability; 5. Psychological disability; 6. Social disability; 7. Handicap. Each question can be answered with a score from 0 to 4 corresponding to: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often.)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Alveolar Bone Atrophy</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients in the control group received Demineralized Bovine Bone Mineral for the maxillary sinus augmentation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in the test group 1 received TCP with particle size from 250 to 1000 µm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in the test group 2 received TCP as in test group1 plus crosslinked Hyaluronic Acid</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Maxillary Sinus Augmentation</intervention_name>
    <description>Biomaterial Graft into the Maxillary Sinus</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Test group 1</arm_group_label>
    <arm_group_label>Test group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Maxillary Sinus Graft with ABBM</intervention_name>
    <description>The maxillary sinuses in the control group are grafted with ABBM</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Anorganic Bovine Bone Mineral (ABBM)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Maxillary Sinus Graft with TCP</intervention_name>
    <description>The maxillary sinuses in the test1 group are grafted with TCP</description>
    <arm_group_label>Test group 1</arm_group_label>
    <other_name>Tricalcium Phosphate (TCP)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Maxillary Sinus Graft with TCP + HA</intervention_name>
    <description>The maxillary sinuses in the test1 group are grafted with TCP + HA</description>
    <arm_group_label>Test group 2</arm_group_label>
    <other_name>hyaluronic acid (HA)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  need for maxillary sinus augmentation&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  residual ridge height less than 3mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  full contraindication to implant surgery,&#xD;
&#xD;
          -  systemic diseases that could negatively influence wound healing;&#xD;
&#xD;
          -  heavy smokers (more than 10 cigarettes/day);&#xD;
&#xD;
          -  head and neck irradiation treatment;&#xD;
&#xD;
          -  uncontrolled diabetes;&#xD;
&#xD;
          -  chronic or acute sinus pathology;&#xD;
&#xD;
          -  uncontrolled periodontal disease;&#xD;
&#xD;
          -  full mouth plaque and bleeding score higher than 25%,&#xD;
&#xD;
          -  tooth extractions in the previous 2 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicola A Valente, DDS, MS</last_name>
    <role>Study Chair</role>
    <affiliation>University of Seville, Spain</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Geneva</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pisa</investigator_affiliation>
    <investigator_full_name>Antonio Barone</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Bone regeneration</keyword>
  <keyword>Biomaterial(s)</keyword>
  <keyword>Implantology</keyword>
  <keyword>Osseointegration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04506827
org study id: SinusAug
nct id: NCT04506827
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Background: Lateral maxillary sinus augmentation (MSA) is a predictable bone regeneration
      technique in case of atrophy of the posterior-upper maxilla. Aimed at obtaining quantity and
      quality of bone suitable for receiving osseointegrated implants, its success is largely due
      to the skill of the surgeon, but also to the characteristics of the biomaterial used.

      Methods: Twenty-four patients needing MSA were included in the study. The patients were
      randomly allocated to 3 different groups: Anorganic Bovine Bone Mineral (ABBM) as control,
      Tricalcium Phosphate (TCP) with or without hyaluronic acid (HA) as test groups. Nine months
      after MSA bone biopsies were harvested for the histomorphometric analysis. Secondary outcomes
      were mean bone gain, intraoperative and post-operative complications, implant insertion
      torque, implant failure and patient related outcome measures (PROMs).
The implant-prosthetic rehabilitation of the atrophic maxilla requires the creation of
      sufficient volumetric quantity of bone, through regeneration techniques, necessary to
      position the implants.

      Maxillary sinus augmentation (MSA) is probably the most predictable and best performing
      technique.

      The present randomized controlled study aims to evaluate and compare, histomorphometrically
      and clinically three different bone substitutes such as: ABBM, Tricalcium Phosphate (TCP)
      with or without the addition of hyaluronic acid (HA) that were used for lateral MSA. This
      study population will be followed until the 3rd year. This study describes histological
      differences between the three groups at 9 months.

      All the patients enrolled in the study received a session of oral hygiene and a periodontal
      examination before the surgical procedure to obtain a more favorable oral environment for
      wound healing. A CBCT was mandatory for all included cases to verify that the maxillary sinus
      was clear and that the residual bone height was 3 mm or less. All the enrolled patients
      received 2 gr. of amoxicillin and clavulanic acid (or 600 mg. of clindamycin for those who
      were allergic to penicillins) as a pre-medication one-hour before surgery. All patients
      rinsed for 1 minute with 0.2% chlorhexidine mouthwash (and twice a day for the following 3
      weeks). Local anesthesia was administered, a mid-crestal incision with mesial and distal
      release were performed to access the lateral bone wall of the maxillary sinus, subsequently,
      ultrasound bone surgery (Piezosurgery ®, Carasco, Italy) with specific tips was used for the
      bone window osteotomy (Figure 1-A). The Schneiderian membrane was reflected and lifted up
      medially with flat sinus curettes. Once the sinus membrane was completely lifted a
      bioabsorbable pericardium membrane (Smartbrane, Regedent AG, Zurich, Switzerland) was applied
      to protect it (Figure 1-B). The randomization sealed envelopes were opened and the clinician
      allocated the patients to one of the three experimental groups:

        1. Control group that received Demineralized Bovine Bone Mineral (Bio-Oss Cancellous,
           Geistlich, Wolhunsen, Switzerland);

        2. Test group 1 that received TCP with particle size ranging from 250 to 1000 µm (Osopia,
           Regedent, Zurich, Switzerland);

        3. Test group 2 that received TCP as in test group1 plus crosslinked Hyaluronic Acid
           (Hyadent BG, Regedent, Zurich, Switzerland) with a ratio 2 to 1.

      the bony window was repositioned, stabilized and covered with a resorbable pericardium
      membrane. Nine months after the MSA a CBCT analysis was required to evaluate the total bone
      height gain.

      Depending on the treatment plan, between one and three implants, bone level (BL) or tissue
      level (TL), of two different manufacturers (Institut Straumann AG, Basel, Switzerland and
      Sweden & Martina, Due Carrare, Italy) were positioned. While preparing the osteotomy implant
      site a bone biopsy was harvested using a trephine. The implant insertion torque was measured
      in Ncm for each implant.

      All patients were prescribed 1gr amoxicillin + clavulanic acid twice daily for 7 days (for
      those who were allergic to penicillin 300mg clindamycin 3 times daily for 7 days) as
      post-operative prophylaxis. All patients received 8mg of dexamethasone immediately after
      surgery and 4 mg of dexamethasone per day were prescribed for the following 5 days.
      Analgesics were prescribed (1gr paracetamol 3 times daily) according to patients' need. The
      use of removable temporary restorations was not recommended during the healing period.

      After an osseointegration period of 3 months, the implants were restored. The prosthetic
      procedures were similar for all groups, impressions were taken with a polyether rubber
      material (Impregum, Espe Dental AG, Seefeld, Germany) and a customized impression tray. Final
      Zirconia screw-retained restorations were delivered after a period of 2/3 weeks, peri-apical
      radiographs were taken and oral hygiene instructions were given to all participants in the
      study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Three groups of patients will be treated with 3 different graft materials
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: The envelope with the group assignment will be opened by the surgeon at the time of surgery and the patient won't be informed.
The clinician who registers clinical parameters won't be informed of the group allocation. The histologist will receive biopsies with a numeric code but without informations of the graft material used.
measure: Histomorphometric parameters of the augmented bone (descriptive)
time frame: 9 months
description: Descriptive analysis of the specimen section at the microscope
measure: Histomorphometric parameters of the augmented bone (% of new bone, marrow, graft)
time frame: 9 months
description: Percentages of newly formed bone, marrow spaces and residual graft particles are reported.
measure: Mean bone gain measured at 9 months through CBCT evaluation
time frame: 9 months
description: radiographic evaluation
measure: Intra-operative
time frame: During surgery
description: clinical evaluation (yes/no) of the presence or occurrence of: sinus membrane perforation, excessive bleeding, lateral sinus cortical bone fracture.
measure: Post-operative complications
time frame: one week
description: clinical evaluation (yes/no) of the presence or occurrence of:symptoms of acute sinusitis, swelling, suppuration, bleeding, trismus, hematoma, wound dehiscence, acute infections.
measure: Post-operative complications
time frame: 9 months
description: clinical evaluation (yes/no) of the presence or occurrence of:symptoms of chronic sinusitis, swelling, suppuration, wound dehiscence, acute infections.
measure: Implant insertion torque measured in Ncm
time frame: 9 months
description: clinical evaluation
measure: Early implant failure
time frame: 12 months
description: clinical evaluation of the osseointegration of the implant into the bone (yes/no)
measure: Patient reported outcome measures
time frame: 9 months
description: All patients will answer a questionnaire regarding the oral health-related quality of life using the 14 questions of the short-form Oral Health Impact Profile (OHIP-14) (This questionnaire consists of 14 questions each one formulated in the following way: "How often (impact item) because of problems with your teeth, mouth or dentures?" The impact items belong to 7 different impact domains: 1. Functional limitations; 2. Physical pain; 3. Psychological discomfort; 4. Physical disability; 5. Psychological disability; 6. Social disability; 7. Handicap. Each question can be answered with a score from 0 to 4 corresponding to: 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, and 4 = very often.)
arm group label: Control group
arm group type: Active Comparator
description: patients in the control group received Demineralized Bovine Bone Mineral for the maxillary sinus augmentation
arm group label: Test group 1
arm group type: Experimental
description: patients in the test group 1 received TCP with particle size from 250 to 1000 µm
arm group label: Test group 2
arm group type: Experimental
description: patients in the test group 2 received TCP as in test group1 plus crosslinked Hyaluronic Acid
intervention type: Procedure
intervention name: Maxillary Sinus Augmentation
description: Biomaterial Graft into the Maxillary Sinus
arm group label: Control group
arm group label: Test group 1
arm group label: Test group 2
intervention type: Device
intervention name: Maxillary Sinus Graft with ABBM
description: The maxillary sinuses in the control group are grafted with ABBM
arm group label: Control group
other name: Anorganic Bovine Bone Mineral (ABBM)
intervention type: Device
intervention name: Maxillary Sinus Graft with TCP
description: The maxillary sinuses in the test1 group are grafted with TCP
arm group label: Test group 1
other name: Tricalcium Phosphate (TCP)
intervention type: Device
intervention name: Maxillary Sinus Graft with TCP + HA
description: The maxillary sinuses in the test1 group are grafted with TCP + HA
arm group label: Test group 2
other name: hyaluronic acid (HA)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicola A Valente, DDS, MS
role: Study Chair
affiliation: University of Seville, Spain
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Pisa
investigator full name: Antonio Barone
investigator title: Professor
mesh term: Alveolar Bone Loss
mesh term: Hyaluronic Acid
sharing ipd: No