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

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ClinicalTrials.gov Identifier: NCT02939092
Recruitment Status : Not yet recruiting
First Posted : October 19, 2016
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Heba Moahmed Fouad, Cairo University

Tracking Information
First Submitted Date  ICMJE October 11, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date January 24, 2018
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Bleeding on brushing, Measurement: asking patient , Unit: Binary [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02939092 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Mouthwash Containing Pomegranate Peel Extract and Chlorhexidine Mouthwash on Bleeding on Brushing
Official Title  ICMJE 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
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gingival Bleeding
Intervention  ICMJE
  • Drug: Pomegranates peel extract
    Pomegranate is antimicrobial
  • Drug: Chlorhexidine
    Chlorhexidine mouthwash is antiplaque agent
Study Arms  ICMJE
  • Experimental: Pomegranate peel extract
    Pomegranate is antimicrobial, anti inflammatory and antioxidant
    Intervention: Drug: Pomegranates peel extract
  • Active Comparator: Chlorhexidine
    Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis
    Intervention: Drug: Chlorhexidine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Heba M Fouad, Bachelor 01001798183 heba.fouad@dentistry.cu.edu.eg
Contact: Manal El shiekh, Lecturer
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939092
Other Study ID Numbers  ICMJE CairoE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Heba Moahmed Fouad, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Salah El Behery, Professor Cairo University
PRS Account Cairo University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP