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NCT Number: NCT02949583

Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

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.

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Key information

Conditions

Gingivitis Dental Deposits Dental Plaque Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Estadual Da Paraiba

Campina Grande, Paraíba, 58.429-500, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Punica granatum Linn.

Drug

Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days

Other names: Pomegranate

Chlorhexidine

Drug

standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days

Other names: Periogard

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidade Estadual da Paraiba

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Oct 31, 2016
Registry last updated
Oct 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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