<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/NCT04495205</url>
  </required_header>
  <id_info>
    <org_study_id>AHReda</org_study_id>
    <nct_id>NCT04495205</nct_id>
  </id_info>
  <brief_title>Effect of Non-eugenol Periodontal Pack With and Without PRF on Post-operative Pain and Wound Healing After Gingival Depigmentation</brief_title>
  <official_title>Clinical Comparison of the Effect of Non-eugenol Containing Periodontal Pack With and Without Platelet Rich Fibrin on Post-operative Pain and Wound Healing After Surgical Gingival Depigmentation: A Randomized Clinical Trial</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>No</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>
      In an era where less than ideal esthetics is not accepted, the request for esthetic&#xD;
      procedures is widely sought after. Melanin, a brown pigment, is the most common natural&#xD;
      pigment contributing to endogenous pigmentation of gingiva. It is a non-hemoglobin-derived&#xD;
      pigment formed by cells called melaonocytes&#xD;
&#xD;
      Dental cosmetic procedures including gingival depigmentation among the young generation are&#xD;
      vastly becoming popular due to the public advertising of what the &quot;ideal smile&quot; should be.&#xD;
      This means that brown/ pigmented gingiva is not esthetically accepted by modern standards.&#xD;
      Numerous techniques for depigmentation were developed including surgical abrasion, lasers,&#xD;
      chemicals and thermal techniques.&#xD;
&#xD;
      The use of post-operative non-eugenol containing periodontal packs acts as a mechanical&#xD;
      barrier for coverage of the denuded area which prevents bleeding and promotes healing by&#xD;
      preventing trauma to the area.&#xD;
&#xD;
      Platelet Rich Fibrin (PRF) is a form of concentrated suspension of growth factors that&#xD;
      promote healing and tissue regeneration. Its use in the medical and dental fields is&#xD;
      expanding during the recent year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gingival depigmentation procedures especially bur abrasion and scalpel surgical techniques&#xD;
      require the use of post-operative periodontal pack. The periodontal pack protects the&#xD;
      surgical site from surface trauma, stops the post-operative bleeding and infection as well as&#xD;
      stabilizing the blood clot and accelerate healing.&#xD;
&#xD;
      However, a review article discussed the adverse effects of periodontal pack as it may cause&#xD;
      plaque induced inflammation, patient discomfort due to difficulty in eating and irritation of&#xD;
      the tissues. In the article, there were clinical trials that advocated that wound healing&#xD;
      could occur without the need of periodontal pack if the surgical wound was kept clean alone&#xD;
      indicating that the pack does not affect the wound healing.&#xD;
&#xD;
      This gave rise to idea to use a material that has been proven to accelerate wound healing and&#xD;
      decrease the patient discomfort to be placed under the periodontal pack which would be used&#xD;
      only as a protective barrier.&#xD;
&#xD;
      Several studies tested platelet rich concentrates as adjunctive methods under periodontal&#xD;
      packs verses periodontal packs alone after surgical abrasion of gingival depigmentation. They&#xD;
      found that there was a clinical, histological and statistical difference between the groups&#xD;
      favoring the platelet concentrate groups.&#xD;
&#xD;
      Using PRF which is a second generation platelet concentrate first developed by Choukroun et&#xD;
      al in 2001 used as a membrane could provide accelerated wound healing properties which would&#xD;
      accelerate ginigival re-epithelization . Using a periodontal pack is conventionally used&#xD;
      which will provide a mechanical barrier to protect the wound from any stimulus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>Early Phase 1</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The patient and the statistician are masked</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>1st day post-operative</time_frame>
    <description>Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>3rd day post-operative</time_frame>
    <description>Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>5th day post-operative</time_frame>
    <description>Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Re-epithelization</measure>
    <time_frame>5th day post-operative</time_frame>
    <description>Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>3rd day post-operative</time_frame>
    <description>Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound healing</measure>
    <time_frame>5th day post-operative</time_frame>
    <description>Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-pigmentation</measure>
    <time_frame>6 months post-operative</time_frame>
    <description>Re-pigmentation of de pigmented site (Kumar, Bhat and Bhat, 2012): minimum score 0 (absence of depigmentation, maximum score 3 (Diffuse brown to black pigmentation, marginal, and attached)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Gingival Pigmentation</condition>
  <arm_group>
    <arm_group_label>Non-eugenol containing periodontal packs with PRF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-eugenol containing periodontal packs</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Non-eugenol containing periodontal packs after gingival de-pigmentation</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PRF under non-eugenol containing periodontal pack</intervention_name>
    <description>Platelet Rich Fibrin under non-eugenol containing periodontal pack</description>
    <arm_group_label>Non-eugenol containing periodontal packs with PRF</arm_group_label>
    <other_name>Platelet Rich Fibrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-eugenol containing periodontal pack</intervention_name>
    <description>Non-eugenol containing periodontal pack after gingival depigmentation</description>
    <arm_group_label>Non-eugenol containing periodontal packs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages18-40 years old&#xD;
&#xD;
          -  Systemically healthy&#xD;
&#xD;
          -  Mild to moderate gingival pigmentations&#xD;
&#xD;
          -  Gingival and plaque index &lt;1&#xD;
&#xD;
          -  Good oral hygiene&#xD;
&#xD;
          -  Thick gingival biotypes&#xD;
&#xD;
          -  Keratinized gingiva &gt;2mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Taking any medications that could affect healing&#xD;
&#xD;
          -  Pervious depigmentation procedures&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Pervious periodontal surgery within the last 6 months before the start of the trial&#xD;
&#xD;
          -  Endodontically treated teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mona S Darhous, Professor</last_name>
      <phone>00201223155955</phone>
      <email>mona.darhous@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Dahiya R, Blaggana A, Panwar V, Kumar S, Kathuria A, Malik S. Clinical and histological comparison of platelet-rich fibrin versus non-eugenol periodontal dressing in the treatment of gingival hyperpigmentation. J Indian Soc Periodontol. 2019 Jul-Aug;23(4):345-350. doi: 10.4103/jisp.jisp_688_18.</citation>
    <PMID>31367132</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Aya Hesham Reda</investigator_full_name>
    <investigator_title>Masters Student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypopigmentation</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_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/NCT04495205
org study id: AHReda
nct id: NCT04495205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In an era where less than ideal esthetics is not accepted, the request for esthetic
      procedures is widely sought after. Melanin, a brown pigment, is the most common natural
      pigment contributing to endogenous pigmentation of gingiva. It is a non-hemoglobin-derived
      pigment formed by cells called melaonocytes

      Dental cosmetic procedures including gingival depigmentation among the young generation are
      vastly becoming popular due to the public advertising of what the "ideal smile" should be.
      This means that brown/ pigmented gingiva is not esthetically accepted by modern standards.
      Numerous techniques for depigmentation were developed including surgical abrasion, lasers,
      chemicals and thermal techniques.

      The use of post-operative non-eugenol containing periodontal packs acts as a mechanical
      barrier for coverage of the denuded area which prevents bleeding and promotes healing by
      preventing trauma to the area.

      Platelet Rich Fibrin (PRF) is a form of concentrated suspension of growth factors that
      promote healing and tissue regeneration. Its use in the medical and dental fields is
      expanding during the recent year.
Gingival depigmentation procedures especially bur abrasion and scalpel surgical techniques
      require the use of post-operative periodontal pack. The periodontal pack protects the
      surgical site from surface trauma, stops the post-operative bleeding and infection as well as
      stabilizing the blood clot and accelerate healing.

      However, a review article discussed the adverse effects of periodontal pack as it may cause
      plaque induced inflammation, patient discomfort due to difficulty in eating and irritation of
      the tissues. In the article, there were clinical trials that advocated that wound healing
      could occur without the need of periodontal pack if the surgical wound was kept clean alone
      indicating that the pack does not affect the wound healing.

      This gave rise to idea to use a material that has been proven to accelerate wound healing and
      decrease the patient discomfort to be placed under the periodontal pack which would be used
      only as a protective barrier.

      Several studies tested platelet rich concentrates as adjunctive methods under periodontal
      packs verses periodontal packs alone after surgical abrasion of gingival depigmentation. They
      found that there was a clinical, histological and statistical difference between the groups
      favoring the platelet concentrate groups.

      Using PRF which is a second generation platelet concentrate first developed by Choukroun et
      al in 2001 used as a membrane could provide accelerated wound healing properties which would
      accelerate ginigival re-epithelization . Using a periodontal pack is conventionally used
      which will provide a mechanical barrier to protect the wound from any stimulus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: The patient and the statistician are masked
measure: Post-operative pain
time frame: 1st day post-operative
description: Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
measure: Post-operative pain
time frame: 3rd day post-operative
description: Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
measure: Post-operative pain
time frame: 5th day post-operative
description: Visual Analog Scale: minimum score 0 (no pain), maximum score 10 (unbearable pain)
measure: Re-epithelization
time frame: 5th day post-operative
description: Toulodine Blue test: dark blue = positive (worst score), light blue = negative (better score)
measure: Wound healing
time frame: 3rd day post-operative
description: Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
measure: Wound healing
time frame: 5th day post-operative
description: Healing Index (Landry, 1985): minimum score 1 (very poor), maximum score 5 (excellent)
measure: Re-pigmentation
time frame: 6 months post-operative
description: Re-pigmentation of de pigmented site (Kumar, Bhat and Bhat, 2012): minimum score 0 (absence of depigmentation, maximum score 3 (Diffuse brown to black pigmentation, marginal, and attached)
arm group label: Non-eugenol containing periodontal packs with PRF
arm group type: Experimental
description: Non-eugenol containing periodontal packs with PRF after gingival de-pigmentation
arm group label: Non-eugenol containing periodontal packs
arm group type: Placebo Comparator
description: Non-eugenol containing periodontal packs after gingival de-pigmentation
intervention type: Biological
intervention name: PRF under non-eugenol containing periodontal pack
description: Platelet Rich Fibrin under non-eugenol containing periodontal pack
arm group label: Non-eugenol containing periodontal packs with PRF
other name: Platelet Rich Fibrin
intervention type: Other
intervention name: Non-eugenol containing periodontal pack
description: Non-eugenol containing periodontal pack after gingival depigmentation
arm group label: Non-eugenol containing periodontal packs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Dahiya R, Blaggana A, Panwar V, Kumar S, Kathuria A, Malik S. Clinical and histological comparison of platelet-rich fibrin versus non-eugenol periodontal dressing in the treatment of gingival hyperpigmentation. J Indian Soc Periodontol. 2019 Jul-Aug;23(4):345-350. doi: 10.4103/jisp.jisp_688_18.
PMID: 31367132
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Aya Hesham Reda
investigator title: Masters Student
mesh term: Hypopigmentation
mesh term: Pain, Postoperative
sharing ipd: No