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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

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.

Condition or disease Intervention/treatment Phase
Gingival Bleeding Drug: Pomegranates peel extract Drug: Chlorhexidine Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Pomegranate peel extract
Pomegranate is antimicrobial, anti inflammatory and antioxidant
Drug: Pomegranates peel extract
Pomegranate is antimicrobial

Active Comparator: Chlorhexidine
Chlorhexidine mouthwash is antiplaque treatment and effective against gingivitis
Drug: Chlorhexidine
Chlorhexidine mouthwash is antiplaque agent




Primary Outcome Measures :
  1. Bleeding on brushing, Measurement: asking patient , Unit: Binary [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Counting streptococcus mutans, Measurement: Agar plate, Unit: CFUs/mL [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939092


Contacts
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Contact: Heba M Fouad, Bachelor 01001798183 heba.fouad@dentistry.cu.edu.eg
Contact: Manal El shiekh, Lecturer

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Salah El Behery, Professor Cairo University

Additional Information:
Publications:
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Responsible Party: Heba Moahmed Fouad, Principle investigator, Cairo University
ClinicalTrials.gov Identifier: NCT02939092     History of Changes
Other Study ID Numbers: CairoE
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heba Moahmed Fouad, Cairo University:
Gingival Bleeding on probing
Additional relevant MeSH terms:
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Gingival Hemorrhage
Hemorrhage
Pathologic Processes
Oral Hemorrhage
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents