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Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

Primary Purpose

Gingivitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Punica granatum Linn.
chlorhexidine
Sponsored by
Universidade Estadual da Paraiba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring DENTAL PLAQUE, MEDICINAL PLANTS, GINGIVITIS

Eligibility Criteria

9 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Universidade Estadual Da Paraiba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Punica granatum Linn.

chlorhexidine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2014
Last Updated
October 27, 2016
Sponsor
Universidade Estadual da Paraiba
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1. Study Identification

Unique Protocol Identification Number
NCT02949583
Brief Title
Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children
Official Title
Clinical Effectiveness and Microbiological Evaluation of a Mouthwash of Pomegranate (Punica Granatum Linn.) in School Children
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual da Paraiba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
DENTAL PLAQUE, MEDICINAL PLANTS, GINGIVITIS

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Punica granatum Linn.
Arm Type
Experimental
Arm Description
The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days.
Arm Title
chlorhexidine
Arm Type
Active Comparator
Arm Description
The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Punica granatum Linn.
Other Intervention Name(s)
Pomegranate
Intervention Description
Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days
Intervention Type
Drug
Intervention Name(s)
chlorhexidine
Other Intervention Name(s)
Periogard
Intervention Description
standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days
Primary Outcome Measure Information:
Title
Difference in the Gingival Index scores.
Description
On day 0, we measured the Plaque Index (PI) (Silness; Löe, 1964) at baseline, on the seventh day and on the fourteenth day.
Time Frame
Baseline, Seventh Day and Fourteeth day (14 days)
Title
Difference in the Gingival Bleeding Index scores.
Description
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.
Time Frame
Baseline, Seventh Day andFourteeth day (14 days)
Title
Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.
Description
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.
Time Frame
Baseline and Fourteeth day (14 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DANÚBIA RM NÓBREGA, Mastering
Organizational Affiliation
Universidade Estadual da Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Estadual Da Paraiba
City
Campina Grande
State/Province
Paraiba
ZIP/Postal Code
58.429-500
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17182487
Citation
Menezes SM, Cordeiro LN, Viana GS. Punica granatum (pomegranate) extract is active against dental plaque. J Herb Pharmacother. 2006;6(2):79-92.
Results Reference
background
PubMed Identifier
21206931
Citation
Bhadbhade SJ, Acharya AB, Rodrigues SV, Thakur SL. The antiplaque efficacy of pomegranate mouthrinse. Quintessence Int. 2011 Jan;42(1):29-36.
Results Reference
background
PubMed Identifier
19170139
Citation
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.
Results Reference
background
PubMed Identifier
17262129
Citation
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.
Results Reference
background

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Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

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