Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02949583

Enrollment

Registered

2016-10-31

Start date

2012-03-31

Completion date

2012-05-31

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingivitis

Keywords

DENTAL PLAQUE, MEDICINAL PLANTS, GINGIVITIS

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

Interventions

DRUGPunica granatum Linn.

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

DRUGchlorhexidine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

9 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Difference in the Gingival Index scores.	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 Gingival Bleeding Index scores.	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.
Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026