NCT02980497

Brief Summary

The objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be included.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable

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, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 30, 2016

Last Update Submit

November 30, 2016

Conditions

PlaqueGingivitisGum InflammationBleeding

Keywords

mouthrinseplaquegingivitisgum bleeding

Outcome Measures

Primary Outcomes (1)

  • Mean Modified Gingival Index (MGI) at 6 Months

    Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.

    6 Months

Secondary Outcomes (8)

  • Mean Modified Gingival Index (MGI) at 1 Month

    1 Month

  • Mean Modified Gingival Index (MGI) at 3 Months

    3 Months

  • Mean Gingival Bleeding Index (BI) at 1 Month

    1 Month

  • Mean Gingival Bleeding Index (BI) at 3 Months

    3 Months

  • Mean Gingival Bleeding Index (BI) at 6 Months

    6 Months

  • +3 more secondary outcomes

Study Arms (3)

Listerine Zero Mouthwash (without alcohol)

ACTIVE COMPARATOR

Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Zero Mouthwash (without alcohol) for 30 seconds.

Other: Listerine Zero Mouthwash (without alcohol)

Listerine Antiseptic Mouthwash (with alcohol)

ACTIVE COMPARATOR

Brushing twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush and rinsing with 20 ml of Listerine Antiseptic Mouthwash (with alcohol) for 30 seconds.

Other: Listerine Antiseptic Mouthwash (with alcohol)

Brush only

NO INTERVENTION

Brush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.

Interventions

Listerine Zero Mouthwash (without alcohol)OTHER

20 ml of rinse for 30 seconds, twice a day

Listerine Zero Mouthwash (without alcohol)
Listerine Antiseptic Mouthwash (with alcohol)OTHER

20 ml of rinse for 30 seconds, twice a day

Listerine Antiseptic Mouthwash (with alcohol)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females 18 years of age or older, in good general and oral health, except gingivitis.
  • Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
  • Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
  • A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
  • A mean gingival index ≥ 1.75 according to the Modified Gingival Index.
  • A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
  • Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
  • Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
  • Absence of fixed or removable orthodontic appliance or removable partial dentures.

You may not qualify if:

  • History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
  • History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject.
  • History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
  • Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
  • Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
  • Current or history of alcohol or drug abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Taubate

Taubaté, São Paulo, 12020-270, Brazil

Location

Related Publications (1)

  • Lynch MC, Cortelli SC, McGuire JA, Zhang J, Ricci-Nittel D, Mordas CJ, Aquino DR, Cortelli JR. The effects of essential oil mouthrinses with or without alcohol on plaque and gingivitis: a randomized controlled clinical study. BMC Oral Health. 2018 Jan 10;18(1):6. doi: 10.1186/s12903-017-0454-6.

    PMID: 29321067DERIVED

MeSH Terms

Conditions

Plaque, AmyloidGingivitisHemorrhageGingival Hemorrhage

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPathologic ProcessesOral Hemorrhage

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Jose Cortelli, Ph. D

    Universidade de Taubate

    PRINCIPAL INVESTIGATOR

  • Sheila Cortelli, Ph.D

    Universidade de Taubate

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 2, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)