Essential Oils Mouthrinse and Dental Floss, Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation

Gingivitis Clinical Trial

Official title:

Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation of an Essential Oils Mouthrinse and Dental Floss.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236963
• Other study ID #: 9/2006b
• Status: Completed
• Phase: N/A
• First received: November 8, 2010
• Last updated: November 9, 2010
• Start date: September 2007
• Est. completion date: September 2008

Study information

• Verified date: July 2010
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Plaque
• Dental Plaque Accumulation
• Gingivitis

Intervention

Drug:
• Essential oils mouthrinse
Commercial mouthrinse with manufacturer's use indications

Device:
• Dental Floss

Locations

Country	Name	City	State
Portugal	Faculdade de Medicina Dentária da Universidade de Lisboa	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
University of Lisbon	Instituto Piaget

Country where clinical trial is conducted

Portugal, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lobene Gingival Index	data collected at the begining of the study and two weeks after mouthrinse or dental floss use	change from baseline in gingival index at two weeks	No
Primary	Saxton & Ouderaa Bleeding Index	data collected at the begining of the study and two weeks after mouthrinse or dental floss use	change from baseline in bleeding index at two weeks	No
Primary	Quigley, Hein & Turesky Dental Plaque Index	data collected at the begining of the study and two weeks after mouthrinse or dental floss use	change from baseline in plaque index at two weeks	No