Clinical trial NCT02949583: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: DENTAL PLAQUE
MEDICINAL PLANTS
GINGIVITIS
Lead sponsor: Universidade Estadual da Paraiba
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 35
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Difference in the Gingival Index scores.
timeFrame: Baseline, Seventh Day and Fourteeth day (14 days)
measure: Difference in the Gingival Bleeding Index scores.
timeFrame: Baseline, Seventh Day andFourteeth day (14 days)
measure: Difference in the Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.
timeFrame: Baseline and Fourteeth day (14 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Campina Grande
country: Brazil
facility: Universidade Estadual Da Paraiba
state: Paraiba
Study officials:
affiliation: Universidade Estadual da Paraiba
name: DANÚBIA RM NÓBREGA, Mastering
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menezes SM, Cordeiro LN, Viana GS. Punica granatum (pomegranate) extract is active against dental plaque. J Herb Pharmacother. 2006;6(2):79-92.
citation: Bhadbhade SJ, Acharya AB, Rodrigues SV, Thakur SL. The antiplaque efficacy of pomegranate mouthrinse. Quintessence Int. 2011 Jan;42(1):29-36.
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.
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.