NCT01236963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

November 8, 2010

Last Update Submit

May 14, 2024

Conditions

Keywords

Clinical trialPrevention mouthrinseDental Floss

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Essential oils mouthrinse

EXPERIMENTAL

Subjects use the essential oils mouthrinse

Drug: Essential oils mouthrinse

Dental floss

ACTIVE COMPARATOR

Subjects use dental floss

Device: Dental Floss

Interventions

Commercial mouthrinse with manufacturer's use indications

Also known as: Listerine Cool Mint
Essential oils mouthrinse
Also known as: Colgate Total dental floss
Dental floss

Eligibility Criteria

Age15 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Medicina Dentária da Universidade de Lisboa

Lisbon, 1649-003, Portugal

Location

Related Publications (5)

  • 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.

    PMID: 17035671BACKGROUND
  • 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.

    PMID: 12699051BACKGROUND
  • 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.

    PMID: 3902908BACKGROUND
  • 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.

    PMID: 15127875BACKGROUND
  • 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.

    PMID: 12691269BACKGROUND

MeSH Terms

Conditions

Gingivitis

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental EquipmentDentistryOral HygienePreventive DentistryEquipment and Supplies

Study Officials

  • Mario F Bernardo, PhD

    Faculdade de Medicina Dentária da Universidade de Lisboa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 9, 2010

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

September 1, 2008

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations