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

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.

Study Overview

• Status: Completed
• Conditions: Gingivitis
• Intervention / Treatment: Drug: Punica granatum Linn.; Drug: chlorhexidine

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraiba
    • Campina Grande, Paraiba, Brazil, 58.429-500
      • Universidade Estadual da Paraiba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Punica granatum Linn.; The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days.	Drug: Punica granatum Linn.; Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days; Other Names: Pomegranate
Active Comparator: chlorhexidine; The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days.	Drug: chlorhexidine; standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days; Other Names: Periogard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Universidade Estadual da Paraiba
• Investigators: Principal Investigator: DANÚBIA RM NÓBREGA, Mastering, Universidade Estadual da Paraiba

Publications and helpful links

General Publications

• Menezes SM, Cordeiro LN, Viana GS. Punica granatum (pomegranate) extract is active against dental plaque. J Herb Pharmacother. 2006;6(2):79-92.
• Bhadbhade SJ, Acharya AB, Rodrigues SV, Thakur SL. The antiplaque efficacy of pomegranate mouthrinse. Quintessence Int. 2011 Jan;42(1):29-36.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 20, 2014
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: DENTAL PLAQUE; MEDICINAL PLANTS; GINGIVITIS
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: Effectiveness of Pomegranate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO