<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/NCT03834649</url>
  </required_header>
  <id_info>
    <org_study_id>271188</org_study_id>
    <nct_id>NCT03834649</nct_id>
  </id_info>
  <brief_title>Pontic Site Development Using Soft Tissue Augmentation</brief_title>
  <official_title>Evaluation of Soft Tissue Biotype and Volume Stability After Soft Tissue Augmentation by Using Mucograft® Versus Partially De-epithelized Connective Tissue Graft to Enhance the Pontic Site in Single Missing Tooth With Deficient Ridge: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nouran Abdulla Mater,MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      in patients with vertical or horizontal defective of there ridge it is difficult to have&#xD;
      prosthetic restoration with natural appearance emetating and simulating the adjacent abutment&#xD;
      emergence profile so this study aims to develop the defective area using two different&#xD;
      materials of soft tissue grafting techniques to restore the missing tissue and regain soft&#xD;
      tissue volume and profile&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PICO P: single pontic site with deficient ridge. I: Soft tissue augmentation with partially&#xD;
      de-epithelized connective tissue graft.&#xD;
&#xD;
      C: Soft tissue augmentation with Mucograft. O: Soft tissue biotype, Soft tissue volume, pain&#xD;
      score and patient satisfaction.&#xD;
&#xD;
      Preoperative measures:&#xD;
&#xD;
        -  All subjects will pass through phase I therapy (Supragingival scalling, subgingival&#xD;
           debridement and oral hygiene instructions) before any surgical procedures.&#xD;
&#xD;
        -  After 4 weeks, all subjects will be examined to determine patient compliance with oral&#xD;
           hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash&#xD;
           twice daily).&#xD;
&#xD;
        -  Eligible patients will be randomized before being enrolled in the study. (T-1 +4 weeks)&#xD;
&#xD;
        -  Study casts for case study will be fabricated and clinical photographs will be taken.&#xD;
&#xD;
        -  Assessment of edentulous defect site and neighboring teeth will be performed by scanning&#xD;
           the study casts.&#xD;
&#xD;
      Surgical phase (T0):&#xD;
&#xD;
      The same operator (N M) will perform all procedures under local anesthesia (4% articaine with&#xD;
      1/200 000 adrenaline Solution), using a local infiltration technique.&#xD;
&#xD;
      The recipient site will be prepared using 15c-blad creating a full-thickness coronal&#xD;
      dissection and a partial thickness apical dissection creating a vestibular pouch.&#xD;
&#xD;
      The grafting procedure then performed and graft will be fixed by suturing at the periphery of&#xD;
      the flap using 5/0 suture material and the rest will be inserted in the vestibular pouch.&#xD;
&#xD;
      The patient will have printed post-surgical instruction and precautions.&#xD;
&#xD;
        -  Intervention for control group :&#xD;
&#xD;
             1. The recipient site will be prepared with a full-thickness coronal dissection and a&#xD;
                partial thickness apical dissection to creat a vestibular pouch.&#xD;
&#xD;
             2. The acellular matrix (Mucograft®) will be sutured using 5/0 suture material around&#xD;
                the defect margin and secured in the vestibular pouch.&#xD;
&#xD;
        -  Intervention for test group :&#xD;
&#xD;
             1. The recipient site will be prepared with a full-thickness coronal dissection and a&#xD;
                partial thickness apical dissection vestibular pouch.&#xD;
&#xD;
             2. The graft which is composed of two parts:The coronal part, which is epithelialized&#xD;
&#xD;
                  -  The apical part, which is formed of connective tissue only.&#xD;
&#xD;
             3. On the defect area, the crestal surface is de-epithelialized with a beveled&#xD;
                incision and the apical surface is prepared with a partial-thickness dissection&#xD;
                with two vertical- releasing incisions extended apically, without involving the&#xD;
                adjacent papillae, in order to create a pouch area.&#xD;
&#xD;
             4. The onlay section (epithelialized area) of the graft will be sutured on the crestal&#xD;
                surface of the defect, while the inlay section (connective tissue) will be inserted&#xD;
                and secured in the vestibular pouch area.&#xD;
&#xD;
        -  Post-operative care:&#xD;
&#xD;
      As with any regenerative site, caution must be exercised in post-operative care and during&#xD;
      oral hygiene practices at or near the surgical site. After 12 hours 875 mg of Amoxicillin and&#xD;
      125 mg of Clavulanic acid tablet (1 g Amoxicillin Clavulanate) twice daily for 7 days,&#xD;
      anti-inflammatory tablet (Amphiltirne ) if the patient need ,maximum three times/day and&#xD;
      chlorhexidine HCL 1.25% mouth wash mouthwash twice daily are prescribed. Sutures will be&#xD;
      removed after 14 days. (12)&#xD;
&#xD;
      * Follow-up (T1, T2,T3):&#xD;
&#xD;
      (T1):2 weeks post-operatively sutures removal . (T2) 3 months post-operatively appointments&#xD;
      will be assigned for the prosthetic preparation and temporization for 2 weeks (T3): 6 months&#xD;
      post-operatively appointments will be assigned for the prosthetic delivery and fill in the&#xD;
      Questionnaire.&#xD;
&#xD;
        -  Criteria for discontinuing intervention:&#xD;
&#xD;
             -  Infection and sloughing of the graft.&#xD;
&#xD;
             -  if the patient wouldn't commit to the follow-ups.&#xD;
&#xD;
        -  Strategies to improve adherence to intervention protocol:&#xD;
&#xD;
      Patient preparation in terms of improving oral hygiene and first phase therapy procedures&#xD;
      will be performed for patient to doctor trust. Complete information concerning the protocol&#xD;
      will be provided and simplified to the patient with reasoning of all the steps included as&#xD;
      the importance of the follow up visits and home medication.&#xD;
&#xD;
      Relevant concomitant care and interventions that are permitted or prohibited during the&#xD;
      trial:&#xD;
&#xD;
      Postoperatively the patients will be using analgesics, oral antibiotic therapy, and&#xD;
      chlorhexidine HCL 1.25% mouthwash mouthwash for at two week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">September 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 25, 2020</primary_completion_date>
  <phase>Phase 3</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>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)</measure>
    <time_frame>6 month</time_frame>
    <description>% of the change in soft tissue thickness of keratinized mucosa through Trans mucosal probing by periodontal probe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>soft tissue stability (% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob)</measure>
    <time_frame>6 month</time_frame>
    <description>% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Alveolar Bone Loss</condition>
  <arm_group>
    <arm_group_label>Mucograft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Soft tissue augmentation of the defective alveolar ridge using Mucograft inside the prepared vestibular pouch leaving part of the mucograft exposed at the crestal area and will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Partially de-epithelialized connective tissue graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft tissue augmentation of the defective alveolar ridge using Partially de-epithelialized connective tissue graft by preparing vestibular pouch at the defect site and place the de-epithelialized part inside the pouch leaving the epithelialized part sutured and exposed at the crestal area</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>partially de-epithelized connective tissue graft</intervention_name>
    <description>graft procedures to obtain simultaneous tissue augmentation in the horizontal and vertical dimensions. The donor site was prepared with a full-thickness coronal dissection and a partial-thickness apical dissection.The objectives were to use a single procedure to achieve simultaneously apico-coronal and buccolingual augmentation,to have a smaller open wound in the donor site and less patient discomfort, and to guarantee better revascularization of the onlay section aided by the submerged connective tissue section of the graft.</description>
    <arm_group_label>Partially de-epithelialized connective tissue graft</arm_group_label>
    <other_name>pontic site development</other_name>
    <other_name>Combination onlay-inlay grafts</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mucograft</intervention_name>
    <description>For preprosthetic defects, a standard mucosal augmentation procedure, which is well reported in the literature, was performed. The surgical site produced by the surgery leaves a &quot;denuded area&quot; supraperiosteally that is addressed by &quot;grafting&quot; with a xenogeneic collagen membrane (Mucograft).&#xD;
purpose of the surgery is to improve the quantity of attached mucosa to facilitate the final dental reconstruction</description>
    <arm_group_label>Mucograft</arm_group_label>
    <other_name>pontic site development</other_name>
    <other_name>pre-prosthetic development</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single missing tooth and the patient decides to have fixed prosthesis as a treatment&#xD;
             option for tooth replacement.&#xD;
&#xD;
          -  Horizontal and\or vertical ridge defect at the pontic site&#xD;
&#xD;
          -  Sufficient inter-arch distance.&#xD;
&#xD;
          -  Restorable neighbouring abutments.&#xD;
&#xD;
          -  Periodontally sound abutments.&#xD;
&#xD;
          -  Skilled and motivated patient in maintaining good oral hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple neighboring missing teeth.&#xD;
&#xD;
          -  Systemic diseases that could affect treatment outcome.&#xD;
&#xD;
          -  Poor oral hygiene.&#xD;
&#xD;
          -  Patient is not motivated to have the treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Nouran A Mater, Master holder</last_name>
    <phone>00201226953337</phone>
    <email>nouranmater133@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Nouran A Mater, Master</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Nouran Abdulla Mater,MD</investigator_full_name>
    <investigator_title>Lectural assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
  </condition_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/NCT03834649
org study id: 271188
nct id: NCT03834649
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
in patients with vertical or horizontal defective of there ridge it is difficult to have
      prosthetic restoration with natural appearance emetating and simulating the adjacent abutment
      emergence profile so this study aims to develop the defective area using two different
      materials of soft tissue grafting techniques to restore the missing tissue and regain soft
      tissue volume and profile
PICO P: single pontic site with deficient ridge. I: Soft tissue augmentation with partially
      de-epithelized connective tissue graft.

      C: Soft tissue augmentation with Mucograft. O: Soft tissue biotype, Soft tissue volume, pain
      score and patient satisfaction.

      Preoperative measures:

        -  All subjects will pass through phase I therapy (Supragingival scalling, subgingival
           debridement and oral hygiene instructions) before any surgical procedures.

        -  After 4 weeks, all subjects will be examined to determine patient compliance with oral
           hygiene procedures (tooth brushing twice daily and chlorhexidine HCL 1.25% mouthwash
           twice daily).

        -  Eligible patients will be randomized before being enrolled in the study. (T-1 +4 weeks)

        -  Study casts for case study will be fabricated and clinical photographs will be taken.

        -  Assessment of edentulous defect site and neighboring teeth will be performed by scanning
           the study casts.

      Surgical phase (T0):

      The same operator (N M) will perform all procedures under local anesthesia (4% articaine with
      1/200 000 adrenaline Solution), using a local infiltration technique.

      The recipient site will be prepared using 15c-blad creating a full-thickness coronal
      dissection and a partial thickness apical dissection creating a vestibular pouch.

      The grafting procedure then performed and graft will be fixed by suturing at the periphery of
      the flap using 5/0 suture material and the rest will be inserted in the vestibular pouch.

      The patient will have printed post-surgical instruction and precautions.

        -  Intervention for control group :

             1. The recipient site will be prepared with a full-thickness coronal dissection and a
                partial thickness apical dissection to creat a vestibular pouch.

             2. The acellular matrix (Mucograft®) will be sutured using 5/0 suture material around
                the defect margin and secured in the vestibular pouch.

        -  Intervention for test group :

             1. The recipient site will be prepared with a full-thickness coronal dissection and a
                partial thickness apical dissection vestibular pouch.

             2. The graft which is composed of two parts:The coronal part, which is epithelialized

                  -  The apical part, which is formed of connective tissue only.

             3. On the defect area, the crestal surface is de-epithelialized with a beveled
                incision and the apical surface is prepared with a partial-thickness dissection
                with two vertical- releasing incisions extended apically, without involving the
                adjacent papillae, in order to create a pouch area.

             4. The onlay section (epithelialized area) of the graft will be sutured on the crestal
                surface of the defect, while the inlay section (connective tissue) will be inserted
                and secured in the vestibular pouch area.

        -  Post-operative care:

      As with any regenerative site, caution must be exercised in post-operative care and during
      oral hygiene practices at or near the surgical site. After 12 hours 875 mg of Amoxicillin and
      125 mg of Clavulanic acid tablet (1 g Amoxicillin Clavulanate) twice daily for 7 days,
      anti-inflammatory tablet (Amphiltirne ) if the patient need ,maximum three times/day and
      chlorhexidine HCL 1.25% mouth wash mouthwash twice daily are prescribed. Sutures will be
      removed after 14 days. (12)

      * Follow-up (T1, T2,T3):

      (T1):2 weeks post-operatively sutures removal . (T2) 3 months post-operatively appointments
      will be assigned for the prosthetic preparation and temporization for 2 weeks (T3): 6 months
      post-operatively appointments will be assigned for the prosthetic delivery and fill in the
      Questionnaire.

        -  Criteria for discontinuing intervention:

             -  Infection and sloughing of the graft.

             -  if the patient wouldn't commit to the follow-ups.

        -  Strategies to improve adherence to intervention protocol:

      Patient preparation in terms of improving oral hygiene and first phase therapy procedures
      will be performed for patient to doctor trust. Complete information concerning the protocol
      will be provided and simplified to the patient with reasoning of all the steps included as
      the importance of the follow up visits and home medication.

      Relevant concomitant care and interventions that are permitted or prohibited during the
      trial:

      Postoperatively the patients will be using analgesics, oral antibiotic therapy, and
      chlorhexidine HCL 1.25% mouthwash mouthwash for at two week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: Soft tissue Biotype (% of the change in soft tissue thickness of keratinized mucosa)
time frame: 6 month
description: % of the change in soft tissue thickness of keratinized mucosa through Trans mucosal probing by periodontal probe.
measure: soft tissue stability (% of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob)
time frame: 6 month
description: % of the difference between baseline and post-opertively results through measuring from the crest of edentulous area to Mucogingival line by periodontal prob.
arm group label: Mucograft
arm group type: Active Comparator
description: Soft tissue augmentation of the defective alveolar ridge using Mucograft inside the prepared vestibular pouch leaving part of the mucograft exposed at the crestal area and will be sutured using 5/0 suture material around the defect margin and secured in the vestibular pouch.
arm group label: Partially de-epithelialized connective tissue graft
arm group type: Experimental
description: Soft tissue augmentation of the defective alveolar ridge using Partially de-epithelialized connective tissue graft by preparing vestibular pouch at the defect site and place the de-epithelialized part inside the pouch leaving the epithelialized part sutured and exposed at the crestal area
intervention type: Procedure
intervention name: partially de-epithelized connective tissue graft
description: graft procedures to obtain simultaneous tissue augmentation in the horizontal and vertical dimensions. The donor site was prepared with a full-thickness coronal dissection and a partial-thickness apical dissection.The objectives were to use a single procedure to achieve simultaneously apico-coronal and buccolingual augmentation,to have a smaller open wound in the donor site and less patient discomfort, and to guarantee better revascularization of the onlay section aided by the submerged connective tissue section of the graft.
arm group label: Partially de-epithelialized connective tissue graft
other name: pontic site development
other name: Combination onlay-inlay grafts
intervention type: Procedure
intervention name: Mucograft
description: For preprosthetic defects, a standard mucosal augmentation procedure, which is well reported in the literature, was performed. The surgical site produced by the surgery leaves a "denuded area" supraperiosteally that is addressed by "grafting" with a xenogeneic collagen membrane (Mucograft).
purpose of the surgery is to improve the quantity of attached mucosa to facilitate the final dental reconstruction
arm group label: Mucograft
other name: pontic site development
other name: pre-prosthetic development
criteria: 
gender: All
minimum age: 19 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nouran A Mater, Master holder
phone: 00201226953337
email: nouranmater133@gmail.com
facility: 
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Nouran Abdulla Mater,MD
investigator title: Lectural assistant
mesh term: Alveolar Bone Loss