NCT02949583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

May 20, 2014

Last Update Submit

October 27, 2016

Conditions

Gingivitis

Keywords

DENTAL PLAQUEMEDICINAL PLANTSGINGIVITIS

Outcome Measures

Primary Outcomes (3)

  • Difference in the Gingival Index scores.

    On day 0, we measured the Plaque Index (PI) (Silness; Löe, 1964) at baseline, on the seventh day and on the fourteenth day.

    Baseline, Seventh Day and Fourteeth day (14 days)

  • Difference in the Gingival Bleeding Index scores.

    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.

    Baseline, Seventh Day andFourteeth day (14 days)

  • Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.

    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.

    Baseline and Fourteeth day (14 days)

Study Arms (2)

Punica granatum Linn.

EXPERIMENTAL

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

Drug: Punica granatum Linn.

chlorhexidine

ACTIVE COMPARATOR

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

Drug: chlorhexidine

Interventions

Punica granatum Linn.DRUG

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

Also known as: Pomegranate
Punica granatum Linn.
chlorhexidineDRUG

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

Also known as: Periogard
chlorhexidine

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual Da Paraiba

Campina Grande, Paraíba, 58.429-500, Brazil

Location

Related Publications (4)

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

    PMID: 17182487BACKGROUND

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

    PMID: 21206931BACKGROUND

  • 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.

    PMID: 19170139BACKGROUND

  • 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.

    PMID: 17262129BACKGROUND

MeSH Terms

Conditions

GingivitisDental Plaque

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • DANÚBIA RM NÓBREGA, Mastering

    Universidade Estadual da Paraiba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor clinical

Study Record Dates

First Submitted

May 20, 2014

First Posted

October 31, 2016

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 31, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)