Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 89 of 291 for:    Sodium Fluoride OR Duraphat

Essential Oil+ELA, Plaque and Gingivitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02884817
Recruitment Status : Completed
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Hans Ragnar Preus, University of Oslo

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Plaque Gingivitis Drug: Experimental: essential oils and ELA Other: Placebo Other: Water Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Plaque- and Gingivitis Inhibiting Capacity of a Commercially Available Mouthwash Containing Essential Oils and Ethyl Lauroyl Arginate: A Parallel, Split-mouth, Double Blind, Randomized, Placebo-controlled Clinical Study
Study Start Date : September 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

Arm Intervention/treatment
Experimental: Listerine prof.gum.ther

The test solution was the commercially available mouthwash product EOELA that contains essential oils and ELA in 21.6% alcohol (Listerine Professional Gum Therapy®, Johnson & Johnson,USA).

Intervention; Rinsing 30 sec with test solution twice daily for 21 days

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 Name: Listerine Professional Gum Therapy®, Johnson & Johnson,USA

Placebo Comparator: 21.6% hydroalcoholic

a hydro-alcohol solution made from 96% ethanol diluted with sterilized water to the final concentration of 21.6%.

Intervention: Rinsing 30 sec with placebo comparator twice daily for 21 days

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 Name: 21.6% hydroalcoholic

Sham Comparator: Plain sterile water

Plain sterile water.

Intervention: Rinsing 30 sec with sham comparator twice daily for 21 days

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.
Other Name: Sham Comparator




Primary Outcome Measures :
  1. Plaque index (Silness & Loe 1964) [ Time Frame: 21 days ]

    0= No plaque

    1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface.
    2. Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye.
    3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.


Secondary Outcome Measures :
  1. The gingival index (GI) (Løe & Silness 1963) [ Time Frame: 21 days ]

    0 No inflammation.

    1. Mild inflammation, slight change in color, slight edema, no bleeding on probing.
    2. Moderate inflammation, moderate glazing, redness, bleeding on probing.
    3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.


Other Outcome Measures:
  1. Ill or side effects [ Time Frame: 21 days ]
    All reported side subjective side effects like "loss of taste", "numbness ...

  2. Objective observation of Discoloration of teeth [ Time Frame: 21 days ]
    Clinical observation of discoloration; Slight to obvious



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

healthy subjects from both gender snon-smoking aged 20-55yr having at least three of the following teeth in maxillary right and left quadrant: the canine, 1st bicuspid, 2nd bicuspid, 1st molar, healthy gingiva and periodontium.

Exclusion Criteria:

pregnancy lactation any chronic diseases clinical signs or symptoms of acute infection in the oral cavity any prescribed or non-prescription systemic or topical medication except oral contraceptives clinical parameters judged as unacceptable by the principle investigator use of systemic antibiotics the last 3 months prior to the start of the study history of alcohol or drug abuse participation in other clinical studies in the last 4weeks


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02884817


Locations
Layout table for location information
Norway
Department of Periodontology, Institute of Clinical Odontology, Dental Faculty, University of Oslo
Oslo, Norway, 0455
Sponsors and Collaborators
University of Oslo

Publications:
Altman DG. Clinical Trials. Practical statistics for medical research. London:Chapman & Hall/CRC, 1991;456.
QUEIROZ DR, MORDAS CJ, MARTINEZ MD, SHANG H, GAMBOGI RJ. Examination of Ethyl-Lauroyl-Arginate-HCl (LAE) Deposition on a Model Enamel Surface. IADR Abstract and Programme 2015; Abstr 0559, Boston March 12th, 2015
http://www.google.com/patents/US20040258632 *
https://www.foodstandards.gov.au/code/applications/documents/AR_A1015.pdf *
http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_017.pdf *
http://www.lamirsa.com/mirenat/pdf/03-PCT.pdf
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_138.pdf
http://www.nature.com/bdj/journal/v218/n6/full/sj.bdj.2015.234.html
http://barkerpr.com/2014/05/advanced-defence-gum-treatment/

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hans Ragnar Preus, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT02884817     History of Changes
Other Study ID Numbers: REK2015/417
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Via scientific journals
Additional relevant MeSH terms:
Layout table for MeSH terms
Listerine
Sodium Fluoride
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs