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/NCT05969132</url>
    </required_header>
    <id_info>
      <org_study_id>FDASU-RecIM122209</org_study_id>
      <nct_id>NCT05969132</nct_id>
    </id_info>
    <brief_title>Digital Versus Conventional Guided Gingivectomy</brief_title>
    <official_title>Fully Digital Guided Gingivectomy in Management of Gummy Smile: Evaluation of Accuracy and Patient Satisfaction</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized controlled clinical study is to compare Fully digital to&#xD;
        conventional guided Gingivectomy procedure in management of excessive gingival display caused&#xD;
        by altered passive eruption type 1A.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
        Does the fully digital guided gingivectomy approach able to introduce a more precise,&#xD;
        accuracy and reliability technique with more patient satisfaction compared to the&#xD;
        conventional guided method?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Nowadays, the concept of smile and dental esthetics is no longer limited to the teeth. The&#xD;
        essentials of a smile involve the relationship between the three primary components: the&#xD;
        teeth, lip framework, and the gingival scaffold.&#xD;
  &#xD;
        The term &quot;pink aesthetics&quot; refers to the aesthetics of gingival tissues, which play a&#xD;
        significant influence in smile aesthetics.&#xD;
  &#xD;
        Excessive gingival display while smiling, also usually known as a &quot;gummy smile,&quot; is a common&#xD;
        esthetic concern among dental patients and, being largely viewed as unesthetic, leads many&#xD;
        patients to seek some form of treatment to address the issue.&#xD;
  &#xD;
        Gummy smile (Excessive gingival display) is recognized by the American Academy of&#xD;
        Periodontology (AAP) as a deformity and mucogingival condition that affects the area around&#xD;
        the teeth.&#xD;
  &#xD;
        This condition could be caused by many etiological factors: short lip,&#xD;
        hypermobile/hyperactive lip, short clinical crowns, dentoalveolar extrusion, altered passive&#xD;
        eruption (APE), gingival hyperplasia, and vertical maxillary excess.&#xD;
  &#xD;
        Altered passive eruption defined as &quot;the gingival margin in the adult is located incisal to&#xD;
        the cervical convexity of the crown and removed from the cementoenamel junction of the&#xD;
        tooth&quot;.&#xD;
  &#xD;
        Altered passive eruption classified into two main classes according to the relationship of&#xD;
        the gingiva to the anatomic crown and furthermore subdivided those classes according to the&#xD;
        position of the osseous crest. The two types are subdivided into four categories: 1A, 1B and&#xD;
        2A, 2B.&#xD;
  &#xD;
        The diagnosis of APE is made on a collective clinical and radiographic examination, it begins&#xD;
        with analyzing the repose during a natural smile followed by analyzing the gingival display,&#xD;
        the alveolar crest level, as well as the lip line of the patient.&#xD;
  &#xD;
        Determination can be made whether a gingivectomy alone will suffice or a gingival flap will&#xD;
        be needed with or without ostectomy will depend of the diagnosis of APE and classification of&#xD;
        each case.&#xD;
  &#xD;
        The selection of one technique over another depends on several patient related factors such&#xD;
        as esthetics, clinical crown to root ratio, root proximity, root morphology, furcation&#xD;
        location, individual tooth position, collective tooth position and ability to restore the&#xD;
        teeth.&#xD;
  &#xD;
        The gingivectomy approach alone is used when 3 mm gingival tissue or greater exists from bone&#xD;
        to gingival crest, and an adequate attached gingiva will remain after surgery (APE type IA).&#xD;
  &#xD;
        A diagnostic wax-up then an intraoral fabricated mock-up representing the desired outcome can&#xD;
        assist in the selection of proper planning of the need for periodontal surgical approach.&#xD;
  &#xD;
        Diagnostic mock-up fabricated using a temporary bis-acrylic resin with a putty guide directly&#xD;
        from the wax-up can be used to provide the patient and clinician with an evaluation of the&#xD;
        future outcome and can be used as a surgical guide for gingivectomy procedures.&#xD;
  &#xD;
        The major limitations with conventional guided gingivectomy procedure would be the time&#xD;
        consumed during making and modifying conventional wax-ups as well as the unpredictable&#xD;
        estimate of where the gingival margin should be.&#xD;
  &#xD;
        Utilization of digital workflows allowed the enhancement of communication and might improve&#xD;
        the predictability of contemporary gingivectomy approach.&#xD;
  &#xD;
        The introduction of computer-aided design and computer-aided manufacturing (CAD-CAM)&#xD;
        techniques has helped surgeons perform more precise and predictable surgery and contributed&#xD;
        to improved esthetics.&#xD;
  &#xD;
        By combining the use of Digital Smile Design and CAD/CAM technology with (3D) printing, a&#xD;
        surgical guide for Gingivectomy procedure could be produced.&#xD;
  &#xD;
        The aim of the present study will be to evaluate accuracy and reliability of digital guided&#xD;
        method of gingivectomy procedure using CAD CAM technology versus conventional method using&#xD;
        resin Mock-up as gingivectomy surgical guide.&#xD;
  &#xD;
        Research Question &quot;Does the fully digital guided gingivectomy approach able to introduce a&#xD;
        more precise, accuracy and reliability technique with more patient satisfaction compared to&#xD;
        the conventional guided method?&quot;&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The current investigation will be a single-blinded clinical trial. Blinding included the assessor, and the statistician. Its impossible for the operator who performed the surgical procedure to be blinded as the interventions will be completely different and the patient also.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Accuracy of both guides</measure>
      <time_frame>Immediately postsurgical, 4 weeks and 2 months after surgery</time_frame>
      <description>Intraoral digital scanning for obtaining gingival contour will be made immediately postsurgical, 4 weeks and 2 months after surgery and exported in STL files format.&#xD;
  Diagnostic waxing-up on poured cast (for group 2) will be digitalized with a model scanner and exported in STL file format.&#xD;
  Accuracy will be evaluated by:&#xD;
  Superimposing postoperative intraoral digital scanning STL files with virtually designed diagnostic waxing STL file (for group 1) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.&#xD;
  Superimposing postoperative intraoral digital scanning STL files with digitized waxing-up STL file (for group 2) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Satisfaction</measure>
      <time_frame>2 months</time_frame>
      <description>A 5-item custom made questionnaire will give to the patients to be answered for assessing their satisfaction with the whole procedure and the results of the procedure performed.&#xD;
  Post-operative pain (POP): It will be evaluated indirectly based on the mean consumption (in mg) of analgesics (ibuprofen)* after the surgical procedures (Wessel and Tatakis, 2008).&#xD;
  Post-operative results&#xD;
  Post-operative swelling: It will be reported by the patients through the first week (7 days) postsurgically based on the Verbal Rating Scale (VRS) values (absent, slight, moderate and severe) (García et al., 2008).&#xD;
  Surgery time&#xD;
  Procedure as a whole</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Altered Passive Eruption of Teeth</condition>
    <arm_group>
      <arm_group_label>Digital workflow-based Protocol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fully digital guided gingivectomy procedure</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mock-up workflow-based Protocol</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Convectional guided gingivectomy procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Fully digital guided gingivectomy procedure</intervention_name>
      <description>Full history with clinical and radiographic examination (CBCT) to aid in patient's selection.&#xD;
  Supra- and sub-gingival debridement.&#xD;
  Oral hygiene instructions (OHI)&#xD;
  Presurgical intraoral scanning using an intraoral scanner (IOS)&#xD;
  Fabrication of the Gingivectomy guide:&#xD;
  Convert (DICOM) file to STL file then merged to STL file corresponding oral soft tissues 3D data obtained by IOS using software of surgical planning.&#xD;
  Digital waxing up with new desired positions of gingival margins and zenith points performed.&#xD;
  Designing Gingivectomy guide then exported to a 3D printer and mill a transparent resin gingivectomy guide.&#xD;
  Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces.&#xD;
  Postoperative care</description>
      <arm_group_label>Digital workflow-based Protocol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Convectional guided gingivectomy procedure</intervention_name>
      <description>Full history with clinical and radiographic examination (CBCT) to aid in patient's selection.&#xD;
  Supra- and sub-gingival debridement with OHI&#xD;
  Gingivectomy guide fabrication:&#xD;
  Impressions and casts obtained.&#xD;
  Waxing-up included new positions of gingival margins and zenith points.&#xD;
  Silicone index with condensation silicone impression materials made with pressure on the cast to reproduce the details of the wax, then filled after setting with resin material and placed in the patient's mouth.&#xD;
  Resin mock-up trimmed with blade to define the correct new gingival level.&#xD;
  After the patient accept the mock-up design will used as Gingivectomy guide.&#xD;
  Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces.&#xD;
  Postoperative care</description>
      <arm_group_label>Mock-up workflow-based Protocol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients complaining of Excessive gingival display (3mm or more gingival display at&#xD;
               full smiling)&#xD;
  &#xD;
            -  Patients classified as Altered Passive Eruption Type 1A&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients need restorative or orthodontic correction.&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Heavy smoker ≥ 10 cigarettes/day.&#xD;
  &#xD;
            -  Poor oral hygiene.&#xD;
  &#xD;
            -  Patients with systemic diseases which could influence the outcome of the therapy e.g.&#xD;
  &#xD;
          (Diabetic patients).&#xD;
  &#xD;
            -  Heavy smoker ≥ 10 cigarettes/day.&#xD;
  &#xD;
            -  Vulnerable groups of patients e.g. (prisoners, handicapped patients and decisionally&#xD;
               impaired individuals)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed E. Amr, Ass. Prof.</last_name>
      <role>Study Director</role>
      <affiliation>Faculty of dentistry Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eslam O. Hashem, Master st.</last_name>
      <phone>+201100673726</phone>
      <email>eslamhashim@dent.asu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Doaa A. Khattab, Ass. Prof.</last_name>
      <phone>+201006814258</phone>
      <email>dr.doaa.adel-khattab@dent.asu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of Fentistry Ain Shams university</name>
        <address>
          <city>Cairo</city>
          <zip>11566</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Ahmed WM, Hans A, Verhaeghe TV, Nguyen C. Managing Excessive Gingival Display Using a Digital Workflow. J Prosthodont. 2020 Jun;29(5):443-447. doi: 10.1111/jopr.13181. Epub 2020 May 6.</citation>
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    <reference>
      <citation>Arias DM, Trushkowsky RD, Brea LM, David SB. Treatment of the Patient with Gummy Smile in Conjunction with Digital Smile Approach. Dent Clin North Am. 2015 Jul;59(3):703-16. doi: 10.1016/j.cden.2015.03.007.</citation>
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      <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>
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      <citation>Geevarghese A, Baskaradoss JK, Alsalem M, Aldahash A, Alfayez W, Alduhaimi T, Alehaideb A, Alsammahi O. Perception of general dentists and laypersons towards altered smile aesthetics. J Orthod Sci. 2019 Aug 8;8:14. doi: 10.4103/jos.JOS_103_18. eCollection 2019.</citation>
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      <citation>Goldman, H.M. &amp; Cohen, D.W. (1968). Periodontal Therapy. 4ed. St. Louis: C.V. Mosby Company.</citation>
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      <citation>Gurrea J, Bruguera A. Wax-up and mock-up. A guide for anterior periodontal and restorative treatments. Int J Esthet Dent. 2014 Summer;9(2):146-62.</citation>
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      <citation>Liu X, Yu J, Zhou J, Tan J. A digitally guided dual technique for both gingival and bone resection during crown lengthening surgery. J Prosthet Dent. 2018 Mar;119(3):345-349. doi: 10.1016/j.prosdent.2017.04.018. Epub 2017 Jul 8.</citation>
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      <citation>Pavone AF, Ghassemian M, Verardi S. Gummy Smile and Short Tooth Syndrome--Part 1: Etiopathogenesis, Classification, and Diagnostic Guidelines. Compend Contin Educ Dent. 2016 Feb;37(2):102-7; quiz 108-10.</citation>
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      <citation>Perakis N, Cocconi R. The decision-making process in interdisciplinary treatment: digital versus conventional approach. A case presentation. Int J Esthet Dent. 2019;14(2):212-224.</citation>
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      <citation>Ruhmann, N.L., Borrasca, C., Araújo, C, A., &amp; Pfau, E.A. (2014). Aesthetic rehabilitation of the &quot;gummy smile&quot; associated to virtual planning with &quot;digital smile design&quot;-DSD. J Surg Clin Dent, 1(1):5-9</citation>
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      <citation>Simon H, Magne P. Clinically based diagnostic wax-up for optimal esthetics: the diagnostic mock-up. J Calif Dent Assoc. 2008 May;36(5):355-62.</citation>
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      <citation>Trushkowsky R, Arias DM, David S. Digital Smile Design concept delineates the final potential result of crown lengthening and porcelain veneers to correct a gummy smile. Int J Esthet Dent. 2016 Autumn;11(3):338-54.</citation>
      <PMID>27433549</PMID>
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      <citation>Vercruyssen M, Cox C, Coucke W, Naert I, Jacobs R, Quirynen M. A randomized clinical trial comparing guided implant surgery (bone- or mucosa-supported) with mental navigation or the use of a pilot-drill template. J Clin Periodontol. 2014 Jul;41(7):717-23. doi: 10.1111/jcpe.12231. Epub 2014 Apr 10.</citation>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Eslam Hashim</investigator_full_name>
      <investigator_title>Master Student</investigator_title>
    </responsible_party>
    <keyword>gummy smile</keyword>
    <keyword>excessive gingival display</keyword>
    <keyword>Altered Passive Eruption</keyword>
    <keyword>gingivectomy</keyword>
    <keyword>fully digital guided</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Exanthema</mesh_term>
    </condition_browse>
    <!-- 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/NCT05969132
  org study id: FDASU-RecIM122209
  nct id: NCT05969132
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled clinical study is to compare Fully digital to
        conventional guided Gingivectomy procedure in management of excessive gingival display caused
        by altered passive eruption type 1A.
  
        The main question it aims to answer is:
  
        Does the fully digital guided gingivectomy approach able to introduce a more precise,
        accuracy and reliability technique with more patient satisfaction compared to the
        conventional guided method?
  Nowadays, the concept of smile and dental esthetics is no longer limited to the teeth. The
        essentials of a smile involve the relationship between the three primary components: the
        teeth, lip framework, and the gingival scaffold.
  
        The term "pink aesthetics" refers to the aesthetics of gingival tissues, which play a
        significant influence in smile aesthetics.
  
        Excessive gingival display while smiling, also usually known as a "gummy smile," is a common
        esthetic concern among dental patients and, being largely viewed as unesthetic, leads many
        patients to seek some form of treatment to address the issue.
  
        Gummy smile (Excessive gingival display) is recognized by the American Academy of
        Periodontology (AAP) as a deformity and mucogingival condition that affects the area around
        the teeth.
  
        This condition could be caused by many etiological factors: short lip,
        hypermobile/hyperactive lip, short clinical crowns, dentoalveolar extrusion, altered passive
        eruption (APE), gingival hyperplasia, and vertical maxillary excess.
  
        Altered passive eruption defined as "the gingival margin in the adult is located incisal to
        the cervical convexity of the crown and removed from the cementoenamel junction of the
        tooth".
  
        Altered passive eruption classified into two main classes according to the relationship of
        the gingiva to the anatomic crown and furthermore subdivided those classes according to the
        position of the osseous crest. The two types are subdivided into four categories: 1A, 1B and
        2A, 2B.
  
        The diagnosis of APE is made on a collective clinical and radiographic examination, it begins
        with analyzing the repose during a natural smile followed by analyzing the gingival display,
        the alveolar crest level, as well as the lip line of the patient.
  
        Determination can be made whether a gingivectomy alone will suffice or a gingival flap will
        be needed with or without ostectomy will depend of the diagnosis of APE and classification of
        each case.
  
        The selection of one technique over another depends on several patient related factors such
        as esthetics, clinical crown to root ratio, root proximity, root morphology, furcation
        location, individual tooth position, collective tooth position and ability to restore the
        teeth.
  
        The gingivectomy approach alone is used when 3 mm gingival tissue or greater exists from bone
        to gingival crest, and an adequate attached gingiva will remain after surgery (APE type IA).
  
        A diagnostic wax-up then an intraoral fabricated mock-up representing the desired outcome can
        assist in the selection of proper planning of the need for periodontal surgical approach.
  
        Diagnostic mock-up fabricated using a temporary bis-acrylic resin with a putty guide directly
        from the wax-up can be used to provide the patient and clinician with an evaluation of the
        future outcome and can be used as a surgical guide for gingivectomy procedures.
  
        The major limitations with conventional guided gingivectomy procedure would be the time
        consumed during making and modifying conventional wax-ups as well as the unpredictable
        estimate of where the gingival margin should be.
  
        Utilization of digital workflows allowed the enhancement of communication and might improve
        the predictability of contemporary gingivectomy approach.
  
        The introduction of computer-aided design and computer-aided manufacturing (CAD-CAM)
        techniques has helped surgeons perform more precise and predictable surgery and contributed
        to improved esthetics.
  
        By combining the use of Digital Smile Design and CAD/CAM technology with (3D) printing, a
        surgical guide for Gingivectomy procedure could be produced.
  
        The aim of the present study will be to evaluate accuracy and reliability of digital guided
        method of gingivectomy procedure using CAD CAM technology versus conventional method using
        resin Mock-up as gingivectomy surgical guide.
  
        Research Question "Does the fully digital guided gingivectomy approach able to introduce a
        more precise, accuracy and reliability technique with more patient satisfaction compared to
        the conventional guided method?"
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The current investigation will be a single-blinded clinical trial. Blinding included the assessor, and the statistician. Its impossible for the operator who performed the surgical procedure to be blinded as the interventions will be completely different and the patient also.
  measure: Accuracy of both guides
  time frame: Immediately postsurgical, 4 weeks and 2 months after surgery
  description: Intraoral digital scanning for obtaining gingival contour will be made immediately postsurgical, 4 weeks and 2 months after surgery and exported in STL files format.
  Diagnostic waxing-up on poured cast (for group 2) will be digitalized with a model scanner and exported in STL file format.
  Accuracy will be evaluated by:
  Superimposing postoperative intraoral digital scanning STL files with virtually designed diagnostic waxing STL file (for group 1) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.
  Superimposing postoperative intraoral digital scanning STL files with digitized waxing-up STL file (for group 2) and obtain matching differences in height of gingival margin in relation to Muco-gingival junction.
  measure: Patient Satisfaction
  time frame: 2 months
  description: A 5-item custom made questionnaire will give to the patients to be answered for assessing their satisfaction with the whole procedure and the results of the procedure performed.
  Post-operative pain (POP): It will be evaluated indirectly based on the mean consumption (in mg) of analgesics (ibuprofen)* after the surgical procedures (Wessel and Tatakis, 2008).
  Post-operative results
  Post-operative swelling: It will be reported by the patients through the first week (7 days) postsurgically based on the Verbal Rating Scale (VRS) values (absent, slight, moderate and severe) (García et al., 2008).
  Surgery time
  Procedure as a whole
  arm group label: Digital workflow-based Protocol
  arm group type: Experimental
  description: Fully digital guided gingivectomy procedure
  arm group label: Mock-up workflow-based Protocol
  arm group type: Active Comparator
  description: Convectional guided gingivectomy procedure
  intervention type: Procedure
  intervention name: Fully digital guided gingivectomy procedure
  description: Full history with clinical and radiographic examination (CBCT) to aid in patient's selection.
  Supra- and sub-gingival debridement.
  Oral hygiene instructions (OHI)
  Presurgical intraoral scanning using an intraoral scanner (IOS)
  Fabrication of the Gingivectomy guide:
  Convert (DICOM) file to STL file then merged to STL file corresponding oral soft tissues 3D data obtained by IOS using software of surgical planning.
  Digital waxing up with new desired positions of gingival margins and zenith points performed.
  Designing Gingivectomy guide then exported to a 3D printer and mill a transparent resin gingivectomy guide.
  Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces.
  Postoperative care
  arm group label: Digital workflow-based Protocol
  intervention type: Procedure
  intervention name: Convectional guided gingivectomy procedure
  description: Full history with clinical and radiographic examination (CBCT) to aid in patient's selection.
  Supra- and sub-gingival debridement with OHI
  Gingivectomy guide fabrication:
  Impressions and casts obtained.
  Waxing-up included new positions of gingival margins and zenith points.
  Silicone index with condensation silicone impression materials made with pressure on the cast to reproduce the details of the wax, then filled after setting with resin material and placed in the patient's mouth.
  Resin mock-up trimmed with blade to define the correct new gingival level.
  After the patient accept the mock-up design will used as Gingivectomy guide.
  Surgical Procedure: anesthetized the patient using local anesthesia, Surgical incision using 15c blade following CEJ anatomy will be made at each tooth using the Gingivectomy guide as reference to new gingival level and being careful to preserve the gingival papillae without involving the palatal surfaces.
  Postoperative care
  arm group label: Mock-up workflow-based Protocol
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ahmed E. Amr, Ass. Prof.
  role: Study Director
  affiliation: Faculty of dentistry Ain Shams University
  last name: Eslam O. Hashem, Master st.
  phone: +201100673726
  email: eslamhashim@dent.asu.edu.eg
  last name: Doaa A. Khattab, Ass. Prof.
  phone: +201006814258
  email: dr.doaa.adel-khattab@dent.asu.edu.eg
  facility: 
  country: Egypt
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  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Eslam Hashim
  investigator title: Master Student
  mesh term: Exanthema