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PlaqueNCT02980497

Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study

A study testing Listerine Zero Mouthwash (without alcohol) and Listerine Antiseptic Mouthwash (with alcohol) in people with Plaque and Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plaque, Gingivitis, Gum Inflammation
What is being tested?
Listerine Zero Mouthwash (without alcohol) and Listerine Antiseptic Mouthwash (with alcohol)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
1 siteBrazil
Study dates
Sep 2013to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
  • Self reported pregnancy or lactation (this is an exclusion criterion due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of Taubate

    Taubaté, São Paulo, 12020-270

Other trials in Brazil

About this study

Official title: Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study

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.

Being tested
Listerine Zero Mouthwash (without alcohol), Listerine Antiseptic Mouthwash (with alcohol)
Keywords
mouthrinse, plaque, gingivitis, gum bleeding
Medical subject headings
Plaque, Amyloid, Gingivitis, Hemorrhage, Gingival Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Listerine Zero Mouthwash (without alcohol)Other

    20 ml of rinse for 30 seconds, twice a day

  • Listerine Antiseptic Mouthwash (with alcohol)Other

    20 ml of rinse for 30 seconds, twice a day

Study groups in NCT02980497
Study groupRoleWhat they receive
Listerine Zero Mouthwash (without alcohol)Active comparatorBrushing 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.
Receives: Other: Listerine Zero Mouthwash (without alcohol)
Listerine Antiseptic Mouthwash (with alcohol)Active comparatorBrushing 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.
Receives: Other: Listerine Antiseptic Mouthwash (with alcohol)
Brush onlyNo interventionBrush only twice daily in the usual manner with an ADA-Accepted Fluoride Toothpaste (Colgate Cavity Protection) using a soft-bristled toothbrush.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 Months

Secondary outcomes (8)

  1. Mean Modified Gingival Index (MGI) at 1 Month

    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.

    Measured: 1 Month

  2. Mean Modified Gingival Index (MGI) at 3 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.

    Measured: 3 Months

  3. Mean Gingival Bleeding Index (BI) at 1 Month

    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.

    Measured: 1 Month

  4. Mean Gingival Bleeding Index (BI) at 3 Months

    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.

    Measured: 3 Months

  5. Mean Gingival Bleeding Index (BI) at 6 Months

    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.

    Measured: 6 Months

  6. Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month

    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.

    Measured: 1 Month

  7. Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months

    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.

    Measured: 3 Months

  8. Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months

    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2016 (estimated)
  2. Study startSep 2013
  3. Primary completionMar 2014
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
370 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02980497
Sponsor's protocol ID
FCLGBP0056
Status last verified
Nov 2016
First submitted
30 Nov 2016
Last updated
2 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29321067

Questions about this trial

What is this clinical trial studying?

A study testing Listerine Zero Mouthwash (without alcohol) and Listerine Antiseptic Mouthwash (with alcohol) in people with Plaque and Gingivitis, run by Johnson & Johnson Consumer and Personal Products Worldwide at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Modified Gingival Index (MGI) at 6 Months (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02980497, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.

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