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Essential Oil+ELA, Plaque and Gingivitis

NCT02884817 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-08-31

No results posted yet for this study

Summary

A commercially available mouth rinse with ethyl lauroyl arginate and essential oils claims to have enhanced antimicrobial properties as compared to the traditional essential oil products. The aim of the present study was to compare the plaque and gingivitis inhibiting effect of the commercial product containing essential oils with ethyl lauroyl arginate with one placebo and one negative control in a modified experimental gingivitis model. In three groups of healthy volunteers, experimental gingivitis was induced and monitored over 21 days, simultaneously treated with the commercial test solution, 21.6% hydro-alcohol solution and sterile water respectively. The maxillary right quadrant of each individual received mouthwash only, whereas the maxillary left quadrant was subject to both rinsing and mechanical oral hygiene. Compliance and side effects were monitored at day 7, 14, and 21. Plaque and gingivitis scores were obtained at baseline and at day 21.

Conditions

  • Dental Plaque
  • Gingivitis

Interventions

DRUG

Experimental: essential oils and ELA

The participants were instructed to insert the tooth guard in Q1 every time they brushed their teeth and to perform a mechanical oral hygiene routine twice a day in the three other quadrants. After brushing properly, they were instructed to rinse for 30s with water before removing the tooth guard. And then rinse again for 30s with water without the mouth guard. Following this procedure the participants rinsed, as instructed, with the Experimental solution, Listerine Gum Therapy. This oral hygiene routine was repeated for 21d.

OTHER

Placebo

The participants were instructed to insert the tooth guard in Q1 every time they brushed their teeth and to perform a mechanical oral hygiene routine twice a day in the three other quadrants. After brushing properly, they were instructed to rinse for 30s with water before removing the tooth guard. And then rinse again for 30s with water without the mouth guard. Following this procedure the participants rinsed, as instructed, with the 21.6% hydroalcoholic solution. This oral hygiene routine was repeated for 21d.

OTHER

Water

The participants were instructed to insert the tooth guard in Q1 every time they brushed their teeth and to perform a mechanical oral hygiene routine twice a day in the three other quadrants. After brushing properly, they were instructed to rinse for 30s with water before removing the tooth guard. And then rinse again for 30s with water without the mouth guard. Following this procedure the participants rinsed, as instructed, with the sterile water, sham comparator. This oral hygiene routine was repeated for 21d.

Sponsors & Collaborators

  • University of Oslo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02884817 on ClinicalTrials.gov