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

Primary Purpose

Gingivitis, Dental Plaque Accumulation

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Essential oils mouthrinse

Dental Floss

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Clinical trial, Prevention mouthrinse, Dental Floss

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Faculdade de Medicina Dentária da Universidade de Lisboa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Essential oils mouthrinse

Dental floss

Arm Description

Subjects use the essential oils mouthrinse

Subjects use dental floss

Outcomes

Primary Outcome Measures

Lobene Gingival Index

data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Saxton & Ouderaa Bleeding Index

data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Quigley, Hein & Turesky Dental Plaque Index

data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Secondary Outcome Measures

Full Information

NCT ID

NCT01236963

First Posted

November 8, 2010

Last Updated

November 9, 2010

Sponsor

University of Lisbon

Collaborators

Instituto Piaget

1. Study Identification

Unique Protocol Identification Number

NCT01236963

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

January 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Lisbon

Collaborators

Instituto Piaget

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis, Dental Plaque Accumulation

Keywords

Clinical trial, Prevention mouthrinse, Dental Floss

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Essential oils mouthrinse

Arm Type

Experimental

Arm Description

Subjects use the essential oils mouthrinse

Arm Title

Dental floss

Arm Type

Active Comparator

Arm Description

Subjects use dental floss

Intervention Type

Drug

Intervention Name(s)

Essential oils mouthrinse

Other Intervention Name(s)

Listerine Cool Mint

Intervention Description

Commercial mouthrinse with manufacturer's use indications

Intervention Type

Device

Intervention Name(s)

Dental Floss

Other Intervention Name(s)

Colgate Total dental floss

Primary Outcome Measure Information:

Title

Lobene Gingival Index

Description

data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Time Frame

change from baseline in gingival index at two weeks

Title

Saxton & Ouderaa Bleeding Index

Description

data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Time Frame

change from baseline in bleeding index at two weeks

Title

Quigley, Hein & Turesky Dental Plaque Index

Description

data collected at the begining of the study and two weeks after mouthrinse or dental floss use

Time Frame

change from baseline in plaque index at two weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mario F Bernardo, PhD

Organizational Affiliation

Faculdade de Medicina Dentária da Universidade de Lisboa

Official's Role

Study Director

Facility Information:

Facility Name

Faculdade de Medicina Dentária da Universidade de Lisboa

City

Lisboa

ZIP/Postal Code

1649-003

Country

Portugal

12. IPD Sharing Statement

Citations:

PubMed Identifier

17035671

Citation

Barnett ML. The rationale for the daily use of an antimicrobial mouthrinse. J Am Dent Assoc. 2006 Nov;137 Suppl:16S-21S. doi: 10.14219/jada.archive.2006.0408. Erratum In: J Am Dent Assoc. 2008 Mar;139(3):252.

Results Reference

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PubMed Identifier

12699051

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. doi: 10.14219/jada.archive.2003.0167. Erratum In: J Am Dent Assoc. 2003 May;134(5):558.

Results Reference

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PubMed Identifier

3902908

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. doi: 10.1111/j.1600-051x.1985.tb00941.x.

Results Reference

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PubMed Identifier

15127875

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. doi: 10.14219/jada.archive.2004.0217.

Results Reference

background

PubMed Identifier

12691269

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.

Results Reference

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Learn more about this trial

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

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