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/NCT06017791</url>
    </required_header>
    <id_info>
      <org_study_id>21623</org_study_id>
      <nct_id>NCT06017791</nct_id>
    </id_info>
    <brief_title>Management of Excess Gingival Display Using Tunnel Technique With 3D Printed PEEK (Polyetheretherketone) Shell: A Case Series</brief_title>
    <acronym>PEEK</acronym>
    <official_title>Management of Excess Gingival Display Using Tunnel Technique With 3D Printed PEEK Shell: A Case Series</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the current study is to evaluate the use of a PEEK shell placed in the anterior&#xD;
        maxilla placed by tunnel technique in decreasing the gingival display&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        While lip repositioning has been established as a treatment modality to address excess gum&#xD;
        display (EGD) , an often overlooked contributing factor is the lack of lip support. This is&#xD;
        often caused by the architecture of the maxilla at the subnasal area. Maxillary overgrowth&#xD;
        may give rise to a subnasal skeletal depression producing decreased lip support and marked&#xD;
        upper lip retraction during a smile.&#xD;
  &#xD;
        Restricting muscle pull by lip repositioning surgery as a treatment option limits muscle&#xD;
        movement, however it does not address lip support. In 2018 an alternative intervention was&#xD;
        later proposed in a case report study . The technique involves raising a full thickness flap&#xD;
        and applying PMMA (polymethyl methacrylate) cement to fill the subnasal depression and limit&#xD;
        the upper lip movement. Since its introduction, a limited number of studies have attempted to&#xD;
        investigate the technique, however there are not enough studies to support the outcome or the&#xD;
        stability of the technique. The aim of the current study is to evaluate the use of a tunnel&#xD;
        technique with a 3D printed PEEK (Polyetherether ketone) shell to fill the skeletal subnasal&#xD;
        depression&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gingival display</measure>
      <time_frame>Day 0 - Month 3 - Month 6</time_frame>
      <description>measured using a periodontal probe in millimeters</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>lip translation</measure>
      <time_frame>Day 0 - Month 3 - Month 6</time_frame>
      <description>measured using a periodontal probe in millimeters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>profile angle</measure>
      <time_frame>Day 0 - Month 6</time_frame>
      <description>lateral cephalometric xray</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>lip length</measure>
      <time_frame>Day 0 - Month 3 - Month 6</time_frame>
      <description>measured using a periodontal probe in millimeters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patient satisfaction</measure>
      <time_frame>Day 7</time_frame>
      <description>measured by a binary Questionnaire ( yes or no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post operative pain</measure>
      <time_frame>Day 7</time_frame>
      <description>Measured by the visual analogue scale ( 0 no pain, 10 worst pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blinded esthetic assessment</measure>
      <time_frame>Month 3- Month 6</time_frame>
      <description>measured by a binary scale (yes or no)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Excessive Gingival Display</condition>
    <arm_group>
      <arm_group_label>PEEK shell in the anterior maxilla inserted by tunnel technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>use of a minimally invasive tunnel technique to fill the skeletal subnasal depression with a PEEK shell in patients with an exaggerated subnasal depression associated with lack of lip support and excessive lip translation</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression</intervention_name>
      <description>The area will be anesthetized using infiltration technique with 1.5ml of anesthetic solution containing Articaine Hydrochloride 68 mg/1.7 ml with Adrenaline 0.017 mg/1.7 ml&#xD;
  Two bilateral full thickness vertical incisions will be created using a #15 blade above the maxillary canines in the alveolar mucosa&#xD;
  A subperiosteal tunnel connecting the two vertical incisions will be created using a periosteal elevator/tunneling knife until the complete communication between the two ends is established&#xD;
  The custom made PEEK framework will be inserted from the incision on one side and eased through until it sits in the subnasal concavity.&#xD;
  Once fitted in place the shell will be fixed in place using two mini screws bilaterally, one on each side.&#xD;
  The two vertical incisions will be closed by interrupted sutures 6-0 Polyglycolic acid suture material</description>
      <arm_group_label>PEEK shell in the anterior maxilla inserted by tunnel technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with excess gingival display 2.5mm or more&#xD;
  &#xD;
            -  Patients with an exaggerated subnasal concavity&#xD;
  &#xD;
            -  Decreased value of SNA ( angle between sella, nation, A point) in cephalometric&#xD;
               measurement&#xD;
  &#xD;
            -  Decreased cephalometric measurement of A to N-perpendicular (perpendicular from N on&#xD;
               FHP)&#xD;
  &#xD;
            -  Decreased value in cephalometric measurement of the convexity at point A (linear&#xD;
               measurement from point A to facial plane)&#xD;
  &#xD;
            -  Decreased value of Ricketts Esthetic plane in cephalometric measurement&#xD;
  &#xD;
            -  Decreased value of Holdaway H-angle in cephalometric measurement&#xD;
  &#xD;
            -  Nasolabial angle 100° ± 20&#xD;
  &#xD;
            -  Patients 20-60 years old&#xD;
  &#xD;
            -  Medically free&#xD;
  &#xD;
            -  Compliant patient that agrees to the follow up period&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant and lactating females&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Diabetics&#xD;
  &#xD;
            -  Patients with parafunctional habits that may affect the outcome of the procedure&#xD;
  &#xD;
            -  Medically compromised patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Farah Sheeba, BDS</last_name>
      <phone>01220700219</phone>
      <email>farah.sheeba1@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Brizuela M, Ines D. Excessive Gingival Display. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470437/</citation>
      <PMID>29262052</PMID>
    </reference>
    <reference>
      <citation>El-Bokle, Dalia &amp; Ghany, Amany. (2022). A sequential diagnostic scheme for excessive gingival display (Gummy Smile). AJO-DO Clinical Companion. 2. 10.1016/j.xaor.2022.05.003</citation>
    </reference>
    <reference>
      <citation>Impellizzeri A, Palmigiani R, Horodynski M, D'alfonso T, Polimeni A, De Stefano A, Galluccio G. Is There a Correlation between Gingival Display and Incisal Inclination in a Gummy Smile? Study on Cephalometric Parameters. Healthcare (Basel). 2023 Jan 25;11(3):344. doi: 10.3390/healthcare11030344.</citation>
      <PMID>36766919</PMID>
    </reference>
    <reference>
      <citation>Monaco A, Streni O, Marci MC, Marzo G, Gatto R, Giannoni M. Gummy smile: clinical parameters useful for diagnosis and therapeutical approach. J Clin Pediatr Dent. 2004 Fall;29(1):19-25. doi: 10.17796/jcpd.29.1.y01l3r4m06q3k2x0.</citation>
      <PMID>15554398</PMID>
    </reference>
    <reference>
      <citation>Toth, J. M. (2012). Biocompatibility of Polyaryletheretherketone Polymers. PEEK Biomaterials Handbook, 81-92. doi:10.1016/b978-1-4377-4463-7.10007-7</citation>
    </reference>
    <reference>
      <citation>Freitas de Andrade P, Meza-Mauricio J, Kern R, Faveri M. Labial Repositioning Using Print Manufactured Polymethylmethacrylate- (PMMA-) Based Cement for Gummy Smile. Case Rep Dent. 2021 Dec 21;2021:7607522. doi: 10.1155/2021/7607522. eCollection 2021.</citation>
      <PMID>34970460</PMID>
    </reference>
    <reference>
      <citation>Arcuri T, da Costa MFP, Ribeiro IM, Barreto BD Junior, Lyra eSilva JP. Labial repositioning using polymethylmethracylate (PMMA)-based cement for esthetic smile rehabilitation-A case report. Int J Surg Case Rep. 2018;49:194-204. doi: 10.1016/j.ijscr.2018.07.008. Epub 2018 Jul 17.</citation>
      <PMID>30029078</PMID>
    </reference>
    <reference>
      <citation>ASSENZA, B. &amp; Carinci, Francesco &amp; CRISTINZI, A. &amp; Sinjari, Bruna &amp; Murmura, Giovanna &amp; Scarano, Antonio. (2011). A COSMETIC TECHNIQUE CALLED LIP REPOSITIONING IN PATIENT OF EXCESSIVE GINGIVAL DISPLAY. European Journal of Inflammation. 9. 115-119.</citation>
    </reference>
    <reference>
      <citation>Dym H, Pierre R 2nd. Diagnosis and Treatment Approaches to a &quot;Gummy Smile&quot;. Dent Clin North Am. 2020 Apr;64(2):341-349. doi: 10.1016/j.cden.2019.12.003. Epub 2020 Jan 24.</citation>
      <PMID>32111273</PMID>
    </reference>
    <reference>
      <citation>Saleem R, Kukreja BJ, Goyal M, Kumar M. Treating short upper lip with &quot;Unified lip repositioning&quot; technique: Two case reports. J Indian Soc Periodontol. 2022 Jan-Feb;26(1):89-93. doi: 10.4103/jisp.jisp_90_20. Epub 2022 Jan 1.</citation>
      <PMID>35136324</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Farah Mamdouh Abdelfatah Mohamed Sheeba</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>2025</ipd_time_frame>
    </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/NCT06017791
  org study id: 21623
  nct id: NCT06017791
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the current study is to evaluate the use of a PEEK shell placed in the anterior
        maxilla placed by tunnel technique in decreasing the gingival display
  While lip repositioning has been established as a treatment modality to address excess gum
        display (EGD) , an often overlooked contributing factor is the lack of lip support. This is
        often caused by the architecture of the maxilla at the subnasal area. Maxillary overgrowth
        may give rise to a subnasal skeletal depression producing decreased lip support and marked
        upper lip retraction during a smile.
  
        Restricting muscle pull by lip repositioning surgery as a treatment option limits muscle
        movement, however it does not address lip support. In 2018 an alternative intervention was
        later proposed in a case report study . The technique involves raising a full thickness flap
        and applying PMMA (polymethyl methacrylate) cement to fill the subnasal depression and limit
        the upper lip movement. Since its introduction, a limited number of studies have attempted to
        investigate the technique, however there are not enough studies to support the outcome or the
        stability of the technique. The aim of the current study is to evaluate the use of a tunnel
        technique with a 3D printed PEEK (Polyetherether ketone) shell to fill the skeletal subnasal
        depression
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Gingival display
  time frame: Day 0 - Month 3 - Month 6
  description: measured using a periodontal probe in millimeters
  measure: lip translation
  time frame: Day 0 - Month 3 - Month 6
  description: measured using a periodontal probe in millimeters
  measure: profile angle
  time frame: Day 0 - Month 6
  description: lateral cephalometric xray
  measure: lip length
  time frame: Day 0 - Month 3 - Month 6
  description: measured using a periodontal probe in millimeters
  measure: patient satisfaction
  time frame: Day 7
  description: measured by a binary Questionnaire ( yes or no)
  measure: Post operative pain
  time frame: Day 7
  description: Measured by the visual analogue scale ( 0 no pain, 10 worst pain)
  measure: blinded esthetic assessment
  time frame: Month 3- Month 6
  description: measured by a binary scale (yes or no)
  arm group label: PEEK shell in the anterior maxilla inserted by tunnel technique
  arm group type: Experimental
  description: use of a minimally invasive tunnel technique to fill the skeletal subnasal depression with a PEEK shell in patients with an exaggerated subnasal depression associated with lack of lip support and excessive lip translation
  intervention type: Other
  intervention name: tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression
  description: The area will be anesthetized using infiltration technique with 1.5ml of anesthetic solution containing Articaine Hydrochloride 68 mg/1.7 ml with Adrenaline 0.017 mg/1.7 ml
  Two bilateral full thickness vertical incisions will be created using a #15 blade above the maxillary canines in the alveolar mucosa
  A subperiosteal tunnel connecting the two vertical incisions will be created using a periosteal elevator/tunneling knife until the complete communication between the two ends is established
  The custom made PEEK framework will be inserted from the incision on one side and eased through until it sits in the subnasal concavity.
  Once fitted in place the shell will be fixed in place using two mini screws bilaterally, one on each side.
  The two vertical incisions will be closed by interrupted sutures 6-0 Polyglycolic acid suture material
  arm group label: PEEK shell in the anterior maxilla inserted by tunnel technique
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Farah Sheeba, BDS
  phone: 01220700219
  email: farah.sheeba1@gmail.com
  citation: Brizuela M, Ines D. Excessive Gingival Display. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470437/
  PMID: 29262052
  citation: El-Bokle, Dalia & Ghany, Amany. (2022). A sequential diagnostic scheme for excessive gingival display (Gummy Smile). AJO-DO Clinical Companion. 2. 10.1016/j.xaor.2022.05.003
  citation: Impellizzeri A, Palmigiani R, Horodynski M, D'alfonso T, Polimeni A, De Stefano A, Galluccio G. Is There a Correlation between Gingival Display and Incisal Inclination in a Gummy Smile? Study on Cephalometric Parameters. Healthcare (Basel). 2023 Jan 25;11(3):344. doi: 10.3390/healthcare11030344.
  PMID: 36766919
  citation: Monaco A, Streni O, Marci MC, Marzo G, Gatto R, Giannoni M. Gummy smile: clinical parameters useful for diagnosis and therapeutical approach. J Clin Pediatr Dent. 2004 Fall;29(1):19-25. doi: 10.17796/jcpd.29.1.y01l3r4m06q3k2x0.
  PMID: 15554398
  citation: Toth, J. M. (2012). Biocompatibility of Polyaryletheretherketone Polymers. PEEK Biomaterials Handbook, 81-92. doi:10.1016/b978-1-4377-4463-7.10007-7
  citation: Freitas de Andrade P, Meza-Mauricio J, Kern R, Faveri M. Labial Repositioning Using Print Manufactured Polymethylmethacrylate- (PMMA-) Based Cement for Gummy Smile. Case Rep Dent. 2021 Dec 21;2021:7607522. doi: 10.1155/2021/7607522. eCollection 2021.
  PMID: 34970460
  citation: Arcuri T, da Costa MFP, Ribeiro IM, Barreto BD Junior, Lyra eSilva JP. Labial repositioning using polymethylmethracylate (PMMA)-based cement for esthetic smile rehabilitation-A case report. Int J Surg Case Rep. 2018;49:194-204. doi: 10.1016/j.ijscr.2018.07.008. Epub 2018 Jul 17.
  PMID: 30029078
  citation: ASSENZA, B. & Carinci, Francesco & CRISTINZI, A. & Sinjari, Bruna & Murmura, Giovanna & Scarano, Antonio. (2011). A COSMETIC TECHNIQUE CALLED LIP REPOSITIONING IN PATIENT OF EXCESSIVE GINGIVAL DISPLAY. European Journal of Inflammation. 9. 115-119.
  citation: Dym H, Pierre R 2nd. Diagnosis and Treatment Approaches to a "Gummy Smile". Dent Clin North Am. 2020 Apr;64(2):341-349. doi: 10.1016/j.cden.2019.12.003. Epub 2020 Jan 24.
  PMID: 32111273
  citation: Saleem R, Kukreja BJ, Goyal M, Kumar M. Treating short upper lip with "Unified lip repositioning" technique: Two case reports. J Indian Soc Periodontol. 2022 Jan-Feb;26(1):89-93. doi: 10.4103/jisp.jisp_90_20. Epub 2022 Jan 1.
  PMID: 35136324
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Farah Mamdouh Abdelfatah Mohamed Sheeba
  investigator title: Principal investigator
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: 2025