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Clinical Trials/NCT02949583
NCT02949583
Completed
Not Applicable

Clinical Effectiveness and Microbiological Evaluation of a Mouthwash of Pomegranate (Punica Granatum Linn.) in School Children

Universidade Estadual da Paraiba1 site in 1 country35 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Punica granatum Linn.
Conditions
Gingivitis
Sponsor
Universidade Estadual da Paraiba
Enrollment
35
Locations
1
Primary Endpoint
Difference in the Gingival Index scores.
Status
Completed
Last Updated
9 years ago

Overview

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.

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

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
May 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

DANÚBIA ROBERTA DE MEDEIROS NÓBREGA

Professor clinical

Universidade Estadual da Paraiba

Eligibility 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

Arms & Interventions

Punica granatum Linn.

The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days.

Intervention: Punica granatum Linn.

chlorhexidine

The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days.

Intervention: chlorhexidine

Outcomes

Primary Outcomes

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.

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.

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.

Study Sites (1)

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