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Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

NCT ID: NCT02949583

Last Updated: 2016-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

Brief Summary

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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

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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

Conditions

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Gingivitis

Keywords

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DENTAL PLAQUE MEDICINAL PLANTS GINGIVITIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Punica granatum Linn.

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

Group Type EXPERIMENTAL

Punica granatum Linn.

Intervention Type DRUG

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

chlorhexidine

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

Group Type ACTIVE_COMPARATOR

chlorhexidine

Intervention Type DRUG

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

Interventions

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Punica granatum Linn.

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

Intervention Type DRUG

chlorhexidine

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

Intervention Type DRUG

Other Intervention Names

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Pomegranate Periogard

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Estadual da Paraiba

OTHER

Sponsor Role lead

Responsible Party

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DANÚBIA ROBERTA DE MEDEIROS NÓBREGA

Professor clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DANÚBIA RM NÓBREGA, Mastering

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual da Paraiba

Locations

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Universidade Estadual Da Paraiba

Campina Grande, Paraíba, Brazil

Site Status

Countries

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Brazil

References

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Menezes SM, Cordeiro LN, Viana GS. Punica granatum (pomegranate) extract is active against dental plaque. J Herb Pharmacother. 2006;6(2):79-92.

Reference Type BACKGROUND
PMID: 17182487 (View on PubMed)

Bhadbhade SJ, Acharya AB, Rodrigues SV, Thakur SL. The antiplaque efficacy of pomegranate mouthrinse. Quintessence Int. 2011 Jan;42(1):29-36.

Reference Type BACKGROUND
PMID: 21206931 (View on PubMed)

DiSilvestro RA, DiSilvestro DJ, DiSilvestro DJ. Pomegranate extract mouth rinsing effects on saliva measures relevant to gingivitis risk. Phytother Res. 2009 Aug;23(8):1123-7. doi: 10.1002/ptr.2759.

Reference Type BACKGROUND
PMID: 19170139 (View on PubMed)

Vasconcelos LC, Sampaio FC, Sampaio MC, Pereira Mdo S, Higino JS, Peixoto MH. Minimum inhibitory concentration of adherence of Punica granatum Linn (pomegranate) gel against S. mutans, S. mitis and C. albicans. Braz Dent J. 2006;17(3):223-7. doi: 10.1590/s0103-64402006000300009.

Reference Type BACKGROUND
PMID: 17262129 (View on PubMed)

Other Identifiers

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Effectiveness of Pomegranate

Identifier Type: -

Identifier Source: org_study_id