Essential Oils Mouthrinse and Dental Floss, Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation - Full Text View

Purpose

It is difficult to obtain patient's compliance with regular interproximal dental hygiene. Dental floss is recognized as an effective procedure to remove dental plaque and prevent gingivitis in the space between teeth, but it is difficult to use and most patients do no do it regularly. Essential oils mouthrinse acts on dental plaque bacteria and helps on gingivitis prevention. These properties may be of interest to control dental plaque accumulation and gingivitis in interproximal areas. The study hypothesis states that there are no differences between the use of an essential oils mouthrinse and dental floss on the reduction of dental plaque accumulation and gingivitis.

Condition	Intervention
Gingivitis Dental Plaque Accumulation	Drug: Essential oils mouthrinse Device: Dental Floss

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation of an Essential Oils Mouthrinse and Dental Floss.

Resource links provided by NLM:

Drug Information available for: Listerine

U.S. FDA Resources

Further study details as provided by University of Lisbon:

Primary Outcome Measures:

Lobene Gingival Index [ Time Frame: change from baseline in gingival index at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse or dental floss use
Saxton & Ouderaa Bleeding Index [ Time Frame: change from baseline in bleeding index at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse or dental floss use
Quigley, Hein & Turesky Dental Plaque Index [ Time Frame: change from baseline in plaque index at two weeks ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Enrollment:	60
Study Start Date:	September 2007
Study Completion Date:	September 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Essential oils mouthrinse Subjects use the essential oils mouthrinse	Drug: Essential oils mouthrinse Commercial mouthrinse with manufacturer's use indications Other Name: Listerine Cool Mint
Active Comparator: Dental floss Subjects use dental floss	Device: Dental Floss Other Name: Colgate Total dental floss

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

To be a student at the Dental Hygiene programme at the Lisbon Dental School
Signature on informed consent form
Have, at least, two quadrant with 6 teeth each
Presence of dental plaque

Exclusion Criteria:

Use of a mouthrinse
Dental hygiene appointment in the past 6 months
Use of antibiotics in the past 3 months
Presence of extensive caries and fractures of teeth

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236963

Locations

Portugal
Faculdade de Medicina Dentária da Universidade de Lisboa
Lisboa, Portugal, 1649-003

Sponsors and Collaborators

University of Lisbon

Instituto Piaget

Investigators

Study Director:

Mario F Bernardo, PhD

Faculdade de Medicina Dentária da Universidade de Lisboa

More Information

Publications:

Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. Review. Erratum in: J Am Dent Assoc. 2008 Mar;139(3):252.

Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. Erratum in: J Am Dent Assoc. 2003 May;134(5):558.

Gordon JM, Lamster IB, Seiger MC. Efficacy of Listerine antiseptic in inhibiting the development of plaque and gingivitis. J Clin Periodontol. 1985 Sep;12(8):697-704.

Sharma N, Charles CH, Lynch MC, Qaqish J, McGuire JA, Galustians JG, Kumar LD. Adjunctive benefit of an essential oil-containing mouthrinse in reducing plaque and gingivitis in patients who brush and floss regularly: a six-month study. J Am Dent Assoc. 2004 Apr;135(4):496-504.

Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.

Responsible Party:	Henrique Soares Luis, Faculdade de Medicina Dentária da Universidade de Lisboa
ClinicalTrials.gov Identifier:	NCT01236963 History of Changes
Other Study ID Numbers:	9/2006b
Study First Received:	November 8, 2010
Last Updated:	November 9, 2010
Health Authority:	Portugal: Health Ethic Committee

Keywords provided by University of Lisbon:

Clinical trial
Prevention mouthrinse
Dental Floss

Additional relevant MeSH terms:

Dental Plaque
Gingivitis
Dental Deposits
Tooth Diseases

Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on May 19, 2013