Essential Oil+ELA, Plaque and Gingivitis

NCT02884817 | Completed Phase 4

• 1 other identifier: REK2015/417
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Plaque index (Silness & Loe 1964)

  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.

  21 days

Secondary Outcomes (1)

• The gingival index (GI) (Løe & Silness 1963)

  21 days

Other Outcomes (2)

• Ill or side effects

  21 days

• Objective observation of Discoloration of teeth

  21 days

Study Arms (3)

Listerine prof.gum.ther

EXPERIMENTAL

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

21.6% hydroalcoholic

PLACEBO COMPARATOR

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

Plain sterile water

SHAM COMPARATOR

Plain sterile water. Intervention: Rinsing 30 sec with sham comparator twice daily for 21 days

Other: Water

Interventions

Experimental: essential oils and ELA DRUG

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.

Also known as: Listerine Professional Gum Therapy®, Johnson & Johnson,USA

Listerine prof.gum.ther

Placebo OTHER

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.

Also known as: 21.6% hydroalcoholic

21.6% hydroalcoholic

Water OTHER

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.

Also known as: Sham Comparator

Plain sterile water

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

Department of Periodontology, Institute of Clinical Odontology, Dental Faculty, University of Oslo

Oslo, Oslo County, 0455, Norway

Location

Related Publications (25)

• McCullough MJ, Farah CS. The role of alcohol in oral carcinogenesis with particular reference to alcohol-containing mouthwashes. Aust Dent J. 2008 Dec;53(4):302-5. doi: 10.1111/j.1834-7819.2008.00070.x.

  PMID: 19133944 BACKGROUND

• Van Leeuwen MP, Slot DE, Van der Weijden GA. Essential oils compared to chlorhexidine with respect to plaque and parameters of gingival inflammation: a systematic review. J Periodontol. 2011 Feb;82(2):174-94. doi: 10.1902/jop.2010.100266. Epub 2010 Nov 2.

  PMID: 21043801 BACKGROUND

• Preus HR, Koldsland OC, Aass AM, Sandvik L, Hansen BF. The plaque- and gingivitis-inhibiting capacity of a commercially available essential oil product. A parallel, split-mouth, single blind, randomized, placebo-controlled clinical study. Acta Odontol Scand. 2013 Nov;71(6):1613-9. doi: 10.3109/00016357.2013.782506. Epub 2013 May 3.

  PMID: 23638764 BACKGROUND

• Hawkins DR, Rocabayera X, Ruckman S, Segret R, Shaw D. Metabolism and pharmacokinetics of ethyl N(alpha)-lauroyl-L-arginate hydrochloride in human volunteers. Food Chem Toxicol. 2009 Nov;47(11):2711-5. doi: 10.1016/j.fct.2009.07.028. Epub 2009 Aug 3.

  PMID: 19651183 BACKGROUND

• Gallob JT, Lynch M, Charles C, Ricci-Nittel D, Mordas C, Gambogi R, Revankar R, Mutti B, Labella R. A randomized trial of ethyl lauroyl arginate-containing mouthrinse in the control of gingivitis. J Clin Periodontol. 2015 Aug;42(8):740-747. doi: 10.1111/jcpe.12428. Epub 2015 Aug 15.

  PMID: 26087864 BACKGROUND

• LOE H, THEILADE E, JENSEN SB. EXPERIMENTAL GINGIVITIS IN MAN. J Periodontol (1930). 1965 May-Jun;36:177-87. doi: 10.1902/jop.1965.36.3.177. No abstract available.

  PMID: 14296927 BACKGROUND

• Preus HR, Aass AM, Hansen BF, Moe B, Gjermo P. A randomized, single-blind, parallel-group clinical study to evaluate the effect of soluble beta-1,3/1,6-glucan on experimental gingivitis in man. J Clin Periodontol. 2008 Mar;35(3):236-41. doi: 10.1111/j.1600-051X.2007.01183.x.

  PMID: 18269662 BACKGROUND

• Altman DG. Clinical Trials. Practical statistics for medical research. London:Chapman & Hall/CRC, 1991;456.

  BACKGROUND

• 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

  BACKGROUND

• http://www.google.com/patents/US20040258632 *

  BACKGROUND

• https://www.foodstandards.gov.au/code/applications/documents/AR_A1015.pdf *

  BACKGROUND

• http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_017.pdf *

  BACKGROUND

• http://www.lamirsa.com/mirenat/pdf/03-PCT.pdf

  BACKGROUND

• http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_138.pdf

  BACKGROUND

• http://www.nature.com/bdj/journal/v218/n6/full/sj.bdj.2015.234.html

  BACKGROUND

• http://barkerpr.com/2014/05/advanced-defence-gum-treatment/

  BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• QUIGLEY GA, HEIN JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962 Jul;65:26-9. doi: 10.14219/jada.archive.1962.0184. No abstract available.

  PMID: 14489483 BACKGROUND

• Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

  PMID: 5264376 BACKGROUND

• Vatne JF, Gjermo P, Sandvik L, Preus HR. Patients' perception of own efforts versus clinically observed outcomes of non-surgical periodontal therapy in a Norwegian population: an observational study. BMC Oral Health. 2015 May 17;15:61. doi: 10.1186/s12903-015-0037-3.

  PMID: 25981528 BACKGROUND

• Preus HR, Dahlen G, Gjermo P, Baelum V. Microbiologic Observations After Four Treatment Strategies Among Patients With Periodontitis Maintaining a High Standard of Oral Hygiene: Secondary Analysis of a Randomized Controlled Clinical Trial. J Periodontol. 2015 Jul;86(7):856-65. doi: 10.1902/jop.2015.140620. Epub 2015 Mar 12.

  PMID: 25762359 BACKGROUND

• Guha N, Boffetta P, Wunsch Filho V, Eluf Neto J, Shangina O, Zaridze D, Curado MP, Koifman S, Matos E, Menezes A, Szeszenia-Dabrowska N, Fernandez L, Mates D, Daudt AW, Lissowska J, Dikshit R, Brennan P. Oral health and risk of squamous cell carcinoma of the head and neck and esophagus: results of two multicentric case-control studies. Am J Epidemiol. 2007 Nov 15;166(10):1159-73. doi: 10.1093/aje/kwm193. Epub 2007 Aug 30.

  PMID: 17761691 BACKGROUND

• Werner CW, Seymour RA. Are alcohol containing mouthwashes safe? Br Dent J. 2009 Nov 28;207(10):E19; discussion 488-9. doi: 10.1038/sj.bdj.2009.1014.

  PMID: 19942865 BACKGROUND

• Valor LO, Norton IKR, Koldsland OC, Aass AM, Grjibovski AM, Preus HR. The plaque and gingivitis inhibiting capacity of a commercially available mouthwash containing essential oils and ethyl lauroyl arginate. A randomized clinical trial. Acta Odontol Scand. 2018 May;76(4):241-246. doi: 10.1080/00016357.2017.1412499. Epub 2017 Dec 7.

  PMID: 29216779 DERIVED

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Interventions

Water

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 31, 2016
• Study Start: September 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 31, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)