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Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

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ClinicalTrials.gov Identifier: NCT02949583
Recruitment Status : Completed
First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
DANÚBIA ROBERTA DE MEDEIROS NÓBREGA, Universidade Estadual da Paraiba

Brief Summary:
The mechanical control of supragingival biofilm is accepted as one of the most important measures to prevent dental caries and periodontal diseases. Nevertheless, maintaining dental surfaces biofilm-free is not an easy task. In this regard, numerous studies researches have demonstrated the effectiveness of mouthwashes containing antimicrobial active ingredients that prevent and control both supragingival biofilm and gingivitis, specially when used adjunctively to mechanical oral hygiene regimens.

Condition or disease Intervention/treatment Phase
Gingivitis Drug: Punica granatum Linn. Drug: chlorhexidine Not Applicable

Detailed Description:
In vitro and clinical researches using Punica granatum Linn shows antimicrobial and antiadherent activity against dental biofilm microorganisms. The purpose of this study was to evaluate the clinical effectiveness of a mouthwash of Punica granatum Linn. against biofilm and gingival inflammation in school children

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Effectiveness and Microbiological Evaluation of a Mouthwash of Pomegranate (Punica Granatum Linn.) in School Children
Study Start Date : March 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012


Arm Intervention/treatment
Experimental: Punica granatum Linn.
The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days.
Drug: Punica granatum Linn.
Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days
Other Name: Pomegranate

Active Comparator: chlorhexidine
The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days.
Drug: chlorhexidine
standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days
Other Name: Periogard




Primary Outcome Measures :
  1. Difference in the Gingival Index scores. [ Time Frame: Baseline, Seventh Day and Fourteeth day (14 days) ]
    On day 0, we measured the Plaque Index (PI) (Silness; Löe, 1964) at baseline, on the seventh day and on the fourteenth day.

  2. Difference in the Gingival Bleeding Index scores. [ Time Frame: Baseline, Seventh Day andFourteeth day (14 days) ]
    On day 0, we measured the Bleeding on Probing Index (BPI) (Ainamo; Bay, 1975) at baseline, on the seventh day and on the fourteenth day.

  3. Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study. [ Time Frame: Baseline and Fourteeth day (14 days) ]
    At baseline, we collected non-stimulated saliva samples into a sterile container for counting of oral streptococci in the laboratory. And on the fourteenth day, we carried out the second saliva collection and measured the clinical indices used.



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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age group: 09-12 years old
  • Presence of at least 20 teeth
  • Simplified Oral Hygiene Index (S-OHI)≥ 1,6

Exclusion Criteria:

  • Use of orthodontic appliance
  • Recent (in the past 2 months)use of antibiotics and mouthwashes

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): NCT02949583


Locations
Brazil
Universidade Estadual Da Paraiba
Campina Grande, Paraiba, Brazil, 58.429-500
Sponsors and Collaborators
Universidade Estadual da Paraiba
Investigators
Principal Investigator: DANÚBIA RM NÓBREGA, Mastering Universidade Estadual da Paraiba

Publications:
Responsible Party: DANÚBIA ROBERTA DE MEDEIROS NÓBREGA, Professor clinical, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier: NCT02949583     History of Changes
Other Study ID Numbers: Effectiveness of Pomegranate
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by DANÚBIA ROBERTA DE MEDEIROS NÓBREGA, Universidade Estadual da Paraiba:
DENTAL PLAQUE
MEDICINAL PLANTS
GINGIVITIS

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents