<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/NCT03812315</url>
  </required_header>
  <id_info>
    <org_study_id>Propolis in 2 vehicles</org_study_id>
    <nct_id>NCT03812315</nct_id>
  </id_info>
  <brief_title>Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children</brief_title>
  <official_title>Antimicrobial Effect OF Propolis Administrated Through Two Different Vehicles In High Caries Risk Children: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nourhan M.Aly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alexandria</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>
      Propolis is a natural product collected by bees to seal holes and repair structures in their&#xD;
      hives. Recently it has attracted much attention as useful substance applied in medicine and&#xD;
      cosmetics thanks to its antimicrobial properties. Contemporary dentistry is an inseparable&#xD;
      part of medicine and therefore attempts were made to use propolis in dentistry, as well.&#xD;
&#xD;
      Purpose of the study: to investigate the effect of propolis administered in chewing gum as&#xD;
      compared to that incorporated in mouthwash on plaque accumulation, microbial population and&#xD;
      patient acceptance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a two parallel arms randomized controlled clinical trial where 60 high caries&#xD;
      risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and&#xD;
      Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing&#xD;
      the necessary consents. The children will be divided randomly into two equal groups (30&#xD;
      children each).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2017</start_date>
  <completion_date type="Actual">February 20, 2019</completion_date>
  <primary_completion_date type="Actual">February 10, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>The study is a two parallel arms randomized controlled clinical trial where 60 high caries risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing the necessary consents. The children will be divided randomly into two equal groups (30 children each)</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The investigator and the participants will not be blinded to the treatment type as each group has to be given different instruction according to their treatment protocol. However, the statistician and the microbiologist will be blinded to the treatment group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Plaque Accumulation</measure>
    <time_frame>Baseline and after 2 weeks</time_frame>
    <description>All children will be examined clinically using the Plaque Control record (O' Leary, Darke and Naylor).&#xD;
The child will be asked to chew a disclosing tablet and let it mix with saliva for 30 seconds and spit it out.&#xD;
Each tooth is divided into 4 surfaces; the plaque accumulations on all surfaces will be scored.&#xD;
The number of positively scored units is divided by the total number of tooth surfaces evaluated, and the result is multiplied by 100 to express the index as a percentage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Microbiological Sampling of Dental Plaque</measure>
    <time_frame>Baseline and after 2 weeks</time_frame>
    <description>On the day of sampling, each child will refrain from tooth brushing in the morning, eating or drinking (except water) at least two hours before sampling time. The plaque will be collected using sterilized toothpicks. Two plaque samples will be collected from each child. Anteriorly, this will be gathered from the buccal and palatal surface of the upper incisors and canines. While posteriorly, the plaque sample will be collected from the upper and lower molars. Finally, each plaque sample will be inoculated in separate vials; each vial contains 1 ml sterile brain heart infusion broth and will be sent to the lab. After 14 days, another plaque sample will be collected as previously mentioned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of Patient's Acceptance</measure>
    <time_frame>After 2 weeks of treatment</time_frame>
    <description>Using Visual Analogue Scale (VAS).Each patient will receive the scale form and instructed to place a vertical mark according his or her personal rating of the preparation received during the treatment period on a horizontal line scaled from 0 to 10 where 0 presented for unacceptable and 10 for acceptable.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Early Childhood Caries</condition>
  <arm_group>
    <arm_group_label>Propolis chewing gum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 % pure raw propolis, 20-35% gum base, 2.5% flavors, 0.3% sorbitol and 0.3% coloring substance. Children will be instructed to chew the specially prepared propolis chewing gum for at least 20 minutes, twice daily, after breakfast and before bedtime.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propolis mouthwash</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The formulation includes 2% pure raw propolis, 40 ml flavors, 150 ml propylene glycol, 60 gm sorbitol, 0.1 g coloring substance and water. Children will be instructed to rinse using the prepared propolis mouthwash for 1 min, twice a day, after breakfast and before bedtime.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Propolis chewing gum</intervention_name>
    <description>Children who will use chewing gum will be instructed to chew a gum for 20 minutes once after breakfast and another before bed time for two weeks.</description>
    <arm_group_label>Propolis chewing gum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Propolis mouthwash</intervention_name>
    <description>Children who will use mouthwash will be instructed to rinse with 10 ml for 60 seconds twice daily once after breakfast and another before bedtime for two weeks.</description>
    <arm_group_label>Propolis mouthwash</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with high caries risk; who have any one of the following condition: visible&#xD;
             cavities or radiographic penetration into the dentin, white spots on smooth surfaces,&#xD;
             restorations within last three years due to caries.&#xD;
&#xD;
          -  Free of any systemic condition.&#xD;
&#xD;
          -  Cooperative children according to Frankl rating scale including positive and&#xD;
             definitely positive scores.&#xD;
&#xD;
          -  Parental acceptance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous use of any propolis containing products.&#xD;
&#xD;
          -  Received any antibiotic 2 weeks before or during the study.&#xD;
&#xD;
          -  Oral infection that compromises the mastication process.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hend S El-Allaky</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nadia A Wahba</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dalia AM Talaat</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azza S Zakaria</last_name>
    <role>Study Director</role>
    <affiliation>Faculty of Pharmacy, Alexandria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <zip>21512</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Imfeld T. Chewing gum--facts and fiction: a review of gum-chewing and oral health. Crit Rev Oral Biol Med. 1999;10(3):405-19. doi: 10.1177/10454411990100030901.</citation>
    <PMID>10759416</PMID>
  </reference>
  <reference>
    <citation>Balouiri M, Sadiki M, Ibnsouda SK. Methods for in vitro evaluating antimicrobial activity: A review. J Pharm Anal. 2016 Apr;6(2):71-79. doi: 10.1016/j.jpha.2015.11.005. Epub 2015 Dec 2.</citation>
    <PMID>29403965</PMID>
  </reference>
  <reference>
    <citation>Santos FA, Bastos EM, Maia AB, Uzeda M, Carvalho MA, Farias LM, Moreira ES. Brazilian propolis: physicochemical properties, plant origin and antibacterial activity on periodontopathogens. Phytother Res. 2003 Mar;17(3):285-9. doi: 10.1002/ptr.1117.</citation>
    <PMID>12672164</PMID>
  </reference>
  <reference>
    <citation>Dodwad V, Kukreja BJ. Propolis mouthwash: A new beginning. J Indian Soc Periodontol. 2011 Apr;15(2):121-5. doi: 10.4103/0972-124X.84379.</citation>
    <PMID>21976834</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 22, 2019</last_update_submitted>
  <last_update_submitted_qc>February 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Nourhan M.Aly</investigator_full_name>
    <investigator_title>Clinical Instructor</investigator_title>
  </responsible_party>
  <keyword>Propoplis</keyword>
  <keyword>chewing gum</keyword>
  <keyword>mouthwash</keyword>
  <keyword>high caries risk children</keyword>
  <keyword>antimicrobial</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propolis</mesh_term>
  </intervention_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/NCT03812315
org study id: Propolis in 2 vehicles
nct id: NCT03812315
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Propolis is a natural product collected by bees to seal holes and repair structures in their
      hives. Recently it has attracted much attention as useful substance applied in medicine and
      cosmetics thanks to its antimicrobial properties. Contemporary dentistry is an inseparable
      part of medicine and therefore attempts were made to use propolis in dentistry, as well.

      Purpose of the study: to investigate the effect of propolis administered in chewing gum as
      compared to that incorporated in mouthwash on plaque accumulation, microbial population and
      patient acceptance.
The study is a two parallel arms randomized controlled clinical trial where 60 high caries
      risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and
      Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing
      the necessary consents. The children will be divided randomly into two equal groups (30
      children each).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a two parallel arms randomized controlled clinical trial where 60 high caries risk children of 6-8 years will be selected from outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, after securing the necessary consents. The children will be divided randomly into two equal groups (30 children each)
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: The investigator and the participants will not be blinded to the treatment type as each group has to be given different instruction according to their treatment protocol. However, the statistician and the microbiologist will be blinded to the treatment group.
measure: Change in Plaque Accumulation
time frame: Baseline and after 2 weeks
description: All children will be examined clinically using the Plaque Control record (O' Leary, Darke and Naylor).
The child will be asked to chew a disclosing tablet and let it mix with saliva for 30 seconds and spit it out.
Each tooth is divided into 4 surfaces; the plaque accumulations on all surfaces will be scored.
The number of positively scored units is divided by the total number of tooth surfaces evaluated, and the result is multiplied by 100 to express the index as a percentage.
measure: Microbiological Sampling of Dental Plaque
time frame: Baseline and after 2 weeks
description: On the day of sampling, each child will refrain from tooth brushing in the morning, eating or drinking (except water) at least two hours before sampling time. The plaque will be collected using sterilized toothpicks. Two plaque samples will be collected from each child. Anteriorly, this will be gathered from the buccal and palatal surface of the upper incisors and canines. While posteriorly, the plaque sample will be collected from the upper and lower molars. Finally, each plaque sample will be inoculated in separate vials; each vial contains 1 ml sterile brain heart infusion broth and will be sent to the lab. After 14 days, another plaque sample will be collected as previously mentioned.
measure: Assessment of Patient's Acceptance
time frame: After 2 weeks of treatment
description: Using Visual Analogue Scale (VAS).Each patient will receive the scale form and instructed to place a vertical mark according his or her personal rating of the preparation received during the treatment period on a horizontal line scaled from 0 to 10 where 0 presented for unacceptable and 10 for acceptable.
arm group label: Propolis chewing gum
arm group type: Experimental
description: 2 % pure raw propolis, 20-35% gum base, 2.5% flavors, 0.3% sorbitol and 0.3% coloring substance. Children will be instructed to chew the specially prepared propolis chewing gum for at least 20 minutes, twice daily, after breakfast and before bedtime.
arm group label: Propolis mouthwash
arm group type: Active Comparator
description: The formulation includes 2% pure raw propolis, 40 ml flavors, 150 ml propylene glycol, 60 gm sorbitol, 0.1 g coloring substance and water. Children will be instructed to rinse using the prepared propolis mouthwash for 1 min, twice a day, after breakfast and before bedtime.
intervention type: Combination Product
intervention name: Propolis chewing gum
description: Children who will use chewing gum will be instructed to chew a gum for 20 minutes once after breakfast and another before bed time for two weeks.
arm group label: Propolis chewing gum
intervention type: Combination Product
intervention name: Propolis mouthwash
description: Children who will use mouthwash will be instructed to rinse with 10 ml for 60 seconds twice daily once after breakfast and another before bedtime for two weeks.
arm group label: Propolis mouthwash
criteria: 
gender: All
minimum age: 6 Years
maximum age: 8 Years
healthy volunteers: No
last name: Hend S El-Allaky
role: Principal Investigator
affiliation: Alexandria University
last name: Nadia A Wahba
role: Study Director
affiliation: Alexandria University
last name: Dalia AM Talaat
role: Study Director
affiliation: Alexandria University
last name: Azza S Zakaria
role: Study Director
affiliation: Faculty of Pharmacy, Alexandria University
facility: 
country: Egypt
citation: Imfeld T. Chewing gum--facts and fiction: a review of gum-chewing and oral health. Crit Rev Oral Biol Med. 1999;10(3):405-19. doi: 10.1177/10454411990100030901.
PMID: 10759416
citation: Balouiri M, Sadiki M, Ibnsouda SK. Methods for in vitro evaluating antimicrobial activity: A review. J Pharm Anal. 2016 Apr;6(2):71-79. doi: 10.1016/j.jpha.2015.11.005. Epub 2015 Dec 2.
PMID: 29403965
citation: Santos FA, Bastos EM, Maia AB, Uzeda M, Carvalho MA, Farias LM, Moreira ES. Brazilian propolis: physicochemical properties, plant origin and antibacterial activity on periodontopathogens. Phytother Res. 2003 Mar;17(3):285-9. doi: 10.1002/ptr.1117.
PMID: 12672164
citation: Dodwad V, Kukreja BJ. Propolis mouthwash: A new beginning. J Indian Soc Periodontol. 2011 Apr;15(2):121-5. doi: 10.4103/0972-124X.84379.
PMID: 21976834
responsible party type: Sponsor-Investigator
investigator affiliation: University of Alexandria
investigator full name: Nourhan M.Aly
investigator title: Clinical Instructor
mesh term: Propolis