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The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing

Primary Purpose

Gingival Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pomegranates peel extract
Chlorhexidine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Bleeding focused on measuring Gingival Bleeding on probing

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children aged 12-15 years old.
  • Cooperative children.
  • Both genders.
  • Medically free.

Exclusion Criteria:

  • Children undergoing orthodontic treatment.
  • Children using any other oral hygiene aid other than routine teeth brushing.
  • Children with known history of allergy to any mouth rinse or drug.
  • Parents unable to give informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pomegranate peel extract

    Chlorhexidine

    Arm Description

    Pomegranate is antimicrobial, anti inflammatory and antioxidant

    Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis

    Outcomes

    Primary Outcome Measures

    Bleeding on brushing, Measurement: asking patient , Unit: Binary

    Secondary Outcome Measures

    Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL

    Full Information

    First Posted
    October 11, 2016
    Last Updated
    January 23, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02939092
    Brief Title
    The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing
    Official Title
    The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing Among a Group of Egyptian Children With Full Permanent Dentition, Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    January 2018 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition.
    Detailed Description
    To evaluate the clinical effectiveness of mouthwash containing pomegranate peel extract and chlorhexidine mouthwash on bleeding on brushing and counting of streptococcus mutans among a group of Egyptian children with permanent dentition. PICO: Population (P): Children with full permanent dentition. Intervention (I): Pomegranates peel extract. Comparator (C): Chlorhexidine. Outcome(O): Primary outcome: Bleeding on brushing, criteria:Asking patient, unit:Binary. Secondary outcome:Counting streptococcus mutans, criteria: Agar plate, unit: CFUs/mL

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Bleeding
    Keywords
    Gingival Bleeding on probing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pomegranate peel extract
    Arm Type
    Experimental
    Arm Description
    Pomegranate is antimicrobial, anti inflammatory and antioxidant
    Arm Title
    Chlorhexidine
    Arm Type
    Active Comparator
    Arm Description
    Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis
    Intervention Type
    Drug
    Intervention Name(s)
    Pomegranates peel extract
    Intervention Description
    Pomegranate is antimicrobial
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidine
    Intervention Description
    Chlorhexidine mouthwash is antiplaque agent
    Primary Outcome Measure Information:
    Title
    Bleeding on brushing, Measurement: asking patient , Unit: Binary
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: children aged 12-15 years old. Cooperative children. Both genders. Medically free. Exclusion Criteria: Children undergoing orthodontic treatment. Children using any other oral hygiene aid other than routine teeth brushing. Children with known history of allergy to any mouth rinse or drug. Parents unable to give informed consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Heba M Fouad, Bachelor
    Phone
    01001798183
    Email
    heba.fouad@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Manal El shiekh, Lecturer
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Salah El Behery, Professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23762148
    Citation
    Howell AB, D'Souza DH. The pomegranate: effects on bacteria and viruses that influence human health. Evid Based Complement Alternat Med. 2013;2013:606212. doi: 10.1155/2013/606212. Epub 2013 May 20.
    Results Reference
    background
    PubMed Identifier
    26955605
    Citation
    Umar D, Dilshad B, Farhan M, Ali A, Baroudi K. The effect of pomegranate mouthrinse on Streptococcus mutans count and salivary pH: An in vivo study. J Adv Pharm Technol Res. 2016 Jan-Mar;7(1):13-6. doi: 10.4103/2231-4040.173266.
    Results Reference
    background
    PubMed Identifier
    25728105
    Citation
    Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.
    Results Reference
    background
    PubMed Identifier
    12397186
    Citation
    Ajdic D, McShan WM, McLaughlin RE, Savic G, Chang J, Carson MB, Primeaux C, Tian R, Kenton S, Jia H, Lin S, Qian Y, Li S, Zhu H, Najar F, Lai H, White J, Roe BA, Ferretti JJ. Genome sequence of Streptococcus mutans UA159, a cariogenic dental pathogen. Proc Natl Acad Sci U S A. 2002 Oct 29;99(22):14434-9. doi: 10.1073/pnas.172501299. Epub 2002 Oct 23.
    Results Reference
    background
    PubMed Identifier
    15943766
    Citation
    Filoche SK, Soma K, Sissons CH. Antimicrobial effects of essential oils in combination with chlorhexidine digluconate. Oral Microbiol Immunol. 2005 Aug;20(4):221-5. doi: 10.1111/j.1399-302X.2005.00216.x.
    Results Reference
    background
    PubMed Identifier
    24800189
    Citation
    Zarfeshany A, Asgary S, Javanmard SH. Potent health effects of pomegranate. Adv Biomed Res. 2014 Mar 25;3:100. doi: 10.4103/2277-9175.129371. eCollection 2014.
    Results Reference
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    Links:
    URL
    http://dx.doi.org/10.1155/2013/606212
    Description
    Related Info
    URL
    http://doi.org/10.4103/2231-4040.173266
    Description
    Related Info
    URL
    http://www.ijdr.in/text.asp?2014/25/6/737/152182
    Description
    Related Info
    URL
    http://doi.org/10.4103/2277-9175.129371
    Description
    Related Info

    Learn more about this trial

    The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing

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