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.
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
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.
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- 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.
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.
- Conditions
- Plaque, Gingivitis, Gum Inflammation, Bleeding
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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.
- First posted2 Dec 2016 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Taubate
- Responsible party
- Sponsor
- Investigators
- Jose Cortelli, Ph. D, Principal investigator, Universidade de TaubateSheila Cortelli, Ph.D, Study chair, Universidade de Taubate
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