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

This study has been completed.

Sponsor:

Collaborator:

Instituto Piaget

Information provided by:

University of Lisbon

ClinicalTrials.gov Identifier:

NCT01236963

First received: November 8, 2010

Last updated: November 9, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2010

Last Updated Date

November 9, 2010

Start Date ^ICMJE

September 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Lobene Gingival Index [ Time Frame: before and two weeks after intervention ] [ 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: before and two weeks after intervention ] [ 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: before and two weeks after intervention ] [ Designated as safety issue: No ]
data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Change History

Complete list of historical versions of study NCT01236963 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Gingivitis
Dental Plaque Accumulation

Intervention ^ICMJE

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

Other Name: Listerine Cool Mint
Device: Dental Floss
Other Name: Colgate Total dental floss

Study Arm (s)

Experimental: Essential oils mouthrinse
Subjects use the essential oils mouthrinse

Intervention: Drug: Essential oils mouthrinse
Active Comparator: Dental floss
Subjects use dental floss

Intervention: Device: Dental Floss

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Portugal

Administrative Information

NCT Number ^ICMJE

NCT01236963

Other Study ID Numbers ^ICMJE

9/2006b

Has Data Monitoring Committee

Responsible Party

Henrique Soares Luis, Faculdade de Medicina Dentária da Universidade de Lisboa

Study Sponsor ^ICMJE

University of Lisbon

Collaborators ^ICMJE

Instituto Piaget

Investigators ^ICMJE

Study Director:

Mario F Bernardo, PhD

Faculdade de Medicina Dentária da Universidade de Lisboa

Information Provided By

University of Lisbon

Verification Date

July 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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