Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949583
• Other study ID #: Effectiveness of Pomegranate
• Status: Completed
• Phase: N/A
• First received: May 20, 2014
• Last updated: October 27, 2016
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: October 2016
• Source: Universidade Estadual da Paraiba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Punica granatum Linn.
Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days
• chlorhexidine
standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days

Locations

Country	Name	City	State
Brazil	Universidade Estadual Da Paraiba	Campina Grande	Paraiba

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual da Paraiba

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes