<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/NCT03754894</url>
  </required_header>
  <id_info>
    <org_study_id>per- 16 29 M</org_study_id>
    <nct_id>NCT03754894</nct_id>
  </id_info>
  <brief_title>Efficacy of a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue</brief_title>
  <official_title>Effect of Using a Ready Made Plastic Stent With Apically Repositioned Flap in Augmentation of the Peri Implant Soft Tissue Randomized Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Keratinized gingiva around dental implants are necessary to achieve esthetic appearance in&#xD;
      the anterior teeth, also it is more resistant to abrasion, recession, less in plaque&#xD;
      accumulation and inflammation, and easy to manipulate during stage two surgery and impression&#xD;
      making in prosthetic stage. For the aforementioned reasons over year's authors have developed&#xD;
      many techniques to increase the amount of keratinized gingiva around the dental implants such&#xD;
      techniques are apically and laterally repositioned flaps , free gingival grafts, acellular&#xD;
      dermal matrix allograft , coronally repositioned flap and sub epithelial connective tissue&#xD;
      flaps . Huh et al compared the effects of the use of a ready-made plastic stent on the width&#xD;
      of peri-implant keratinized mucosa with those of conventional methods. In addition, the&#xD;
      effect of a plastic stent on peri-implant soft tissue was examined through histological&#xD;
      observations. Reported that the width of the keratinized mucosa was significantly higher and&#xD;
      the distance from the top of the implant platform to the mucogingival junction was&#xD;
      significantly longer in the ready-made plastic stent group.&#xD;
&#xD;
      Thus this study will be performed to compare between the effect of the use of a ready- made&#xD;
      plastic stent on the width of peri-implant keratinized tissue and that of conventional&#xD;
      methods during first stage of implant surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective clinical study will be conducted on Twenty patients will be selected from&#xD;
      the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department,&#xD;
      Faculty of Dentistry, Ain Shams University This methodology will be reviewed by Ain shams&#xD;
      university, faculty of dentistry research ethics committee&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Healthy adult patients as evidenced by Burkett's oral medicine health history&#xD;
           questionnaire.&#xD;
&#xD;
        2. Both genders.&#xD;
&#xD;
        3. Age from 20 -50 years old.&#xD;
&#xD;
        4. Having at least one missing tooth at Posterior area (premolars or molars).&#xD;
&#xD;
        5. Attached gingiva width below 3 mm.&#xD;
&#xD;
        6. Patient should agree to sign a written consent after the nature of the study will be&#xD;
           explained.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Smokers ( &gt;10 cigs/day ) .&#xD;
&#xD;
        2. Vulnerable groups (as pregnant females and decisional impaired individuals) will be&#xD;
           excluded from the study.&#xD;
&#xD;
        3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.&#xD;
&#xD;
        4. Prisoners and handicapped patients.&#xD;
&#xD;
        5. Patients with periodontal or periapical infections.&#xD;
&#xD;
      Patients met the eligibility criteria will be randomly allocated using computer assisted&#xD;
      randomization through numbered sealed envelopes into two treatment modalities groups: -&#xD;
&#xD;
      Group I (with ready-made plastic stent): Will include 10 patients where combined full /&#xD;
      partial thickness apically repositioned flap with paracrestal lingual incision will be&#xD;
      performed for implant placement followed by healing abutment placement covered by ready-made&#xD;
      plastic stent.&#xD;
&#xD;
      Group II (control): Will include 10 patients where combined full / partial thickness apically&#xD;
      repositioned flap with paracrestal lingual incision will be performed for implant placement&#xD;
      followed by healing abutment placement then suturing the flap in place.&#xD;
&#xD;
      All patients will receive healing abutments in first stage of implant surgery.&#xD;
&#xD;
      This proposal will be reviewed by the research ethics committee, the procedure will be fully&#xD;
      explained to the patients and they will sign an informed consent&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>increasing attached gingiva width around implant</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Loss of Keratinized Gingiva Around Dental Implants</condition>
  <arm_group>
    <arm_group_label>goup 1(with readymade plastic stent )</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2 (control)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement then suturing the flap in place.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ready made plastic stent application</intervention_name>
    <description>full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.</description>
    <arm_group_label>goup 1(with readymade plastic stent )</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>simple interrupted sutures</intervention_name>
    <description>full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement and securing the flap with simple interrupted sutures</description>
    <arm_group_label>group 2 (control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - 1- Healthy adult patients as evidenced by Burkett's oral medicine health history&#xD;
        questionnaire.&#xD;
&#xD;
        2- Both genders. 3- Age from 20 -50 years old. 4- Having at least one missing tooth at&#xD;
        Posterior area (premolars or molars). 5- Attached gingiva width below 3 mm. 6- Patient&#xD;
        should agree to sign a written consent after the nature of the study will be explained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Smokers ( &gt;10 cigs/day ) .(Ata-Ali et al , 2015)&#xD;
&#xD;
          2. Vulnerable groups (as pregnant females and decisional impaired individuals) will be&#xD;
             excluded from the study.&#xD;
&#xD;
          3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.&#xD;
&#xD;
          4. Prisoners and handicapped patients.&#xD;
&#xD;
          5. Patients with periodontal or periapical infections.&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ainshams Dental School</name>
      <address>
        <city>Cairo</city>
        <zip>11516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>May 4, 2021</last_update_submitted>
  <last_update_submitted_qc>May 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>ahmed hamdy mahmoud</investigator_full_name>
    <investigator_title>teaching assistant of oral medicine and periodontology</investigator_title>
  </responsible_party>
  <keyword>dental implants</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03754894
org study id: per- 16 29 M
nct id: NCT03754894
lead sponsor: 
has dmc: Yes
Keratinized gingiva around dental implants are necessary to achieve esthetic appearance in
      the anterior teeth, also it is more resistant to abrasion, recession, less in plaque
      accumulation and inflammation, and easy to manipulate during stage two surgery and impression
      making in prosthetic stage. For the aforementioned reasons over year's authors have developed
      many techniques to increase the amount of keratinized gingiva around the dental implants such
      techniques are apically and laterally repositioned flaps , free gingival grafts, acellular
      dermal matrix allograft , coronally repositioned flap and sub epithelial connective tissue
      flaps . Huh et al compared the effects of the use of a ready-made plastic stent on the width
      of peri-implant keratinized mucosa with those of conventional methods. In addition, the
      effect of a plastic stent on peri-implant soft tissue was examined through histological
      observations. Reported that the width of the keratinized mucosa was significantly higher and
      the distance from the top of the implant platform to the mucogingival junction was
      significantly longer in the ready-made plastic stent group.

      Thus this study will be performed to compare between the effect of the use of a ready- made
      plastic stent on the width of peri-implant keratinized tissue and that of conventional
      methods during first stage of implant surgery.
This prospective clinical study will be conducted on Twenty patients will be selected from
      the outpatient clinic of Oral Medicine, Periodontology, and Oral Diagnosis department,
      Faculty of Dentistry, Ain Shams University This methodology will be reviewed by Ain shams
      university, faculty of dentistry research ethics committee

      Inclusion criteria:

        1. Healthy adult patients as evidenced by Burkett's oral medicine health history
           questionnaire.

        2. Both genders.

        3. Age from 20 -50 years old.

        4. Having at least one missing tooth at Posterior area (premolars or molars).

        5. Attached gingiva width below 3 mm.

        6. Patient should agree to sign a written consent after the nature of the study will be
           explained.

      Exclusion criteria:

        1. Smokers ( >10 cigs/day ) .

        2. Vulnerable groups (as pregnant females and decisional impaired individuals) will be
           excluded from the study.

        3. Patients with poor oral hygiene or not willing to perform oral hygiene measures.

        4. Prisoners and handicapped patients.

        5. Patients with periodontal or periapical infections.

      Patients met the eligibility criteria will be randomly allocated using computer assisted
      randomization through numbered sealed envelopes into two treatment modalities groups: -

      Group I (with ready-made plastic stent): Will include 10 patients where combined full /
      partial thickness apically repositioned flap with paracrestal lingual incision will be
      performed for implant placement followed by healing abutment placement covered by ready-made
      plastic stent.

      Group II (control): Will include 10 patients where combined full / partial thickness apically
      repositioned flap with paracrestal lingual incision will be performed for implant placement
      followed by healing abutment placement then suturing the flap in place.

      All patients will receive healing abutments in first stage of implant surgery.

      This proposal will be reviewed by the research ethics committee, the procedure will be fully
      explained to the patients and they will sign an informed consent
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: increasing attached gingiva width around implant
time frame: 6 months
arm group label: goup 1(with readymade plastic stent )
arm group type: Experimental
description: Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.
arm group label: group 2 (control)
arm group type: Experimental
description: Will include 10 patients where combined full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement then suturing the flap in place.
intervention type: Device
intervention name: ready made plastic stent application
description: full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.
arm group label: goup 1(with readymade plastic stent )
intervention type: Procedure
intervention name: simple interrupted sutures
description: full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement and securing the flap with simple interrupted sutures
arm group label: group 2 (control)
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: ahmed hamdy mahmoud
investigator title: teaching assistant of oral medicine and periodontology
sharing ipd: Undecided