Mouthwash of Pomegranate Against Biofilm and Gingival Inflammation in School Children

Not Applicable

Completed

• Conditions: Gingivitis
• Interventions: Drug: Punica granatum Linn.; Drug: chlorhexidine

• Registration Number: NCT02949583
• Lead Sponsor: Universidade Estadual da Paraiba

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

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2014-05-20
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-27
• Last Update Submitted: 2016-10-27
• Study First Posted: 2016-10-31
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Punica granatum Linn.	Punica granatum Linn.	The childrens used the mouthwash contain pomegranate 6,25% twice daily for 14 days.
chlorhexidine	chlorhexidine	The childrens used the mouthwash contain chlorhexidine 0.12% twice daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Difference in the Gingival Index scores.	Baseline, Seventh Day and Fourteeth day (14 days)	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 Microbiological analysis of saliva for oral streptococcus count evolution from the start till the end of the study.	Baseline and Fourteeth day (14 days)	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.
Difference in the Gingival Bleeding Index scores.	Baseline, Seventh Day andFourteeth day (14 days)	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.

Trial Locations

Locations (1)

Universidade Estadual Da Paraiba; 🇧🇷 Campina Grande, Paraiba, Brazil