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GingivitisPhase 4NCT05121909

A Study of Experimental Mouthwashes

A Phase 4 study testing Colgate (R) Cavity Protection Toothpaste, Colgate (R) Cello Toothbrush and Prototype 1 Mouthwash in people with Gingivitis and Plaque, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Canada.

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 purpose of this study is to evaluate the safety and efficacy of experimental mouthwash formulations compared to a hydroalcohol control mouthwash and a positive control mouthwash for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a twelve-week product usage period. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Gingivitis, Plaque
What is being tested?
Colgate (R) Cavity Protection Toothpaste, Colgate (R) Cello Toothbrush and Prototype 1 Mouthwash
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
1 siteCanada
Study dates
15 Nov 2021to 14 Apr 2022
Phase
Phase 4
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 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
  • Evidence of a personally signed and dated informed consent document indicating the participant (or legally acceptable representative) has been informed of all pertinent aspects of the trial
  • Able to read and understand the local language (participant is capable of reading the documents)
  • Adequate oral hygiene (that is, brush teeth daily and exhibit no signs of oral neglect)
  • Adults, 18 to 59 years of age, in good general and oral health without any known allergy to commercial dental products or cosmetics
  • Negative pregnancy urine tests (females of child-bearing potential only)
Show all 14Show fewer
  • Females of childbearing potential must be using a medically acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study (men do not have to use a medically acceptable method of birth control before or during the study)
  • 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 greater than or equal to (>=) 1.95 per the modified gingival index at baseline
  • A mean plaque index >= 1.95 per the 6 site turesky modification of the quigley-hein plaque index at baseline
  • Greater than or equal to 10 percent (%) bleeding sites at baseline
  • 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 and discretion of the dental examiner
  • 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, mouthwashes and red food dye
  • Dental prophylaxis within four weeks prior to Baseline visit
  • More than three sites that have periodontal pockets depths measuring 5 millimeters (mm) in depth
  • History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
  • Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication (ibuprofen, aspirin) is acceptable at the discretion of the investigator
  • Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, sodium fluoride with Cetylpyridinium chloride (CPC), stannous fluoride, zinc or chlorhexidine digluconate containing mouthwashes and toothpastes within the four weeks prior to the baseline exam
Show all 18Show fewer
  • Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
  • Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results)
  • Self-reported smokeless tobacco user including snuff, chewing tobacco, vaping and e-cigarette usage
  • Suspected alcohol or substance abuse (example, amphetamines, benzodiazepines, cocaine, marijuana, opiates)
  • Significant unstable or uncontrolled medical condition which may interfere with a participants participation in the study, including cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD), immunocompromised state (weakened immune system) from solid organ transplant, serious heart conditions, (such as heart failure, coronary artery disease, or cardiomyopathies) Sickle cell disease, Type 2 diabetes mellitus
  • Participation in any clinical trial within 30 days of screening visit
  • Diagnosed temporo-mandibular joint dysfunction/disorder
  • Participants who wear bruxing devices, dental aligners, retainers
  • Participants who were previously screened and ineligible or were randomized to receive investigational product
  • Participants who are related to those persons involved directly or indirectly with the conduct of this study (that is, principal investigator, sub-investigators, study coordinators, other site personnel, employees of Johnson \& Johnson subsidiaries, contractors of Johnson \& Johnson, and the families of each)
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this study
  • Coronavirus Disease 2019 (COVID-19) restrictions: a) History of a confirmed COVID-19 infection in the last 30 days; b) Contact with a COVID-19-infected person within 14 days prior to enrollment; c) Any international travel within 14 days prior to enrollment including members in the same household; d) Participants with self-reported symptoms within the past 2 weeks: i) Unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomach aches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, fever or chest pain/tightness; ii) Temperature >= 38.0 degree Celsius (°C)/100.4 degree Fahrenheit (°F), measured by thermometer which is adjusted for core temperature; iii) Use of fever reducers within the past 2 days of each onsite visit

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • All Sum Research Center Ltd.; 6635 Kitimat Road, Units 36 & 37

    Mississauga, Ontario, Canada, L5N 6J2

Other trials in Canada

About this study

Official title: Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes

The purpose of this study is to evaluate the safety and efficacy of experimental mouthwash formulations compared to a hydroalcohol control mouthwash and a positive control mouthwash for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a twelve-week product usage period.

Conditions
Gingivitis, Plaque
Being tested
Colgate (R) Cavity Protection Toothpaste, Colgate (R) Cello Toothbrush, Prototype 1 Mouthwash, Prototype 2 Mouthwash, Prototype 3 Mouthwash
Medical subject headings
Gingivitis, Plaque, Amyloid

What participants receive

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

  • Colgate (R) Cavity Protection ToothpasteOther

    Participants will use Colgate (R) Cavity Protection Toothpaste for brushing teeth twice daily.

  • Colgate (R) Cello ToothbrushDevice

    Participants will use Colgate (R) Cello Toothbrush for brushing teeth twice daily.

  • Prototype 1 MouthwashOther

    Participants will use 20 mL of Prototype 1 Mouthwash for 30 seconds after brushing twice daily.

  • Prototype 2 MouthwashOther

    Participants will use 20 mL of Prototype 2 Mouthwash for 30 seconds after brushing twice daily.

  • Prototype 3 MouthwashOther

    Participants will use 20 mL of Prototype 3 Mouthwash for 30 seconds after brushing twice daily.

  • Listerine (R) Cool Mint (R) Antiseptic MouthwashOther

    Participants will use 20 mL of Listerine (R) Cool Mint (R) Antiseptic Mouthwash for 30 seconds after brushing twice daily.

  • 5% Hydroalcohol MouthwashOther

    Participants will use 20 mL of 5% Hydroalcohol Mouthwash for 30 seconds after brushing twice daily.

Study groups in NCT05121909
Study groupRoleWhat they receive
Prototype 1 MouthwashExperimentalParticipants will brush their teeth using Colgate (registered [R]) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 milliliters (mL) of the Prototype 1 Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: Prototype 1 Mouthwash
Prototype 2 MouthwashExperimentalParticipants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Prototype 2 Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: Prototype 2 Mouthwash
Prototype 3 MouthwashExperimentalParticipants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Prototype 3 Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: Prototype 3 Mouthwash
Listerine (R) Cool Mint (R) Antiseptic Mouthwash (Positive Control)Active comparatorParticipants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the Listerine Cool Mint Antiseptic Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: Listerine (R) Cool Mint (R) Antiseptic Mouthwash
5 Percent (%) Hydroalcohol Mouthwash (Negative Control)Active comparatorParticipants will brush their teeth using Colgate (R) Cello Toothbrush and Colgate (R) Cavity Protection Toothpaste twice daily and rinse with 20 mL of the 5% Hydroalcohol Mouthwash for 30 seconds, twice a day following brushing on Day 0 under supervision and up to 12 weeks unsupervised at home.
Receives: Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: 5% Hydroalcohol Mouthwash

What is being measured

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

  1. Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use

    Gingivitis will be assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth where 0=normal (absence of inflammation), 1=mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2= mild inflammation of the entire gingival unit; 3= moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4= severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.

    Measured: After 12 weeks

  2. Whole-mouth Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use

    Plaque area will be scored by the turesky modification of the quigley-hein plaque index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0=no plaque; 1= separate flecks or discontinuous band of plaque around the gingival (cervical) margin; 2=thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin; 3=band of plaque wider than 1 mm but less than 1/3 of the surface; 4=plaque covering 1/3 or more, but less than 2/3 of the surface; 5=plaque covering 2/3 or more of the surface.

    Measured: After 12 weeks

Secondary outcomes (6)

  1. Whole-mouth Mean TPI Score After 1 and 4 Weeks of Product use

    Plaque area will be scored by the turesky modification of the quigley-hein plaque index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0=no plaque; 1= separate flecks or discontinuous band of plaque around the gingival (cervical) margin; 2=thin (up to 1mm), continuous band of plaque at the gingival margin; 3=band of plaque wider than 1 mm but less than 1/3 of the surface; 4=plaque covering 1/3 or more, but less than 2/3 of the surface; 5=plaque covering 2/3 or more of the surface.

    Measured: After 1 and 4 weeks

  2. Whole-mouth Mean MGI Score After 1 and 4 Weeks of Product use

    Gingivitis will be assessed by the MGI on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth where 0=normal (absence of inflammation), 1=mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2= mild inflammation of the entire gingival unit; 3= moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4= severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.

    Measured: After 1 and 4 weeks

  3. Whole-Mouth Mean Expanded Gingival Bleeding Index (EBI) Score at 1, 4 and 12 Weeks

    Bleeding will be assessed according to the EBI, 168 Sites. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0=absence of bleeding after 30 seconds; 1=bleeding after 30 seconds; 2=immediate bleeding.

    Measured: 1, 4 and 12 weeks

  4. Percentage of Bleeding Sites, Based on the EBI Score at 1, 4 and 12 Weeks

    Percentage of bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degrees, while in contact with the sulcular epithelium. Each of 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0=absence of bleeding after 30 seconds; 1=bleeding after 30 seconds; 2=immediate bleeding.

    Measured: 1, 4 and 12 weeks

  5. Log10 Transformed Total Bacterial Count After 4 and 12 Weeks of Product use

    Log10 transformed total bacterial count will be assessed by quantitative polymerase chain reaction (qPCR) targeting the 16S recombinant deoxyribonucleic acid (rDNA) in six sampling sites in the mouth (saliva, tongue, buccal mucosa, gingiva, supragingival and subgingival plaque) after 4 and 12 weeks of product use.

    Measured: After 4 and 12 weeks

  6. Log10 Transformed Bacterial Counts After 4 and 12 Weeks of Product use

    Log10 transformed bacterial counts of selected species of interest (including Fusobacterium nucleatum, Porphyromons gingivalis and Actinomyces oris) will be assessed by qPCR targeting the 16S rDNA in six sampling sites in the mouth (saliva, tongue, buccal mucosa, gingiva, supragingival and subgingival plaque) after 4 and 12 weeks of product use.

    Measured: After 4 and 12 weeks

Timeline

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

  1. First posted16 Nov 2021
  2. Study start15 Nov 2021
  3. Primary completion14 Apr 2022
  4. Study completion14 Apr 2022

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05121909
Sponsor's protocol ID
CCSORC004216
Other IDs
CCSORC004216
Status last verified
Nov 2023
First submitted
15 Nov 2021
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

  • Araujo MWB, Charles CA, Weinstein RB, McGuire JA, Parikh-Das AM, Du Q, Zhang J, Berlin JA, Gunsolley JC. Meta-analysis of the effect of an essential oil-containing mouthrinse on gingivitis and plaque. J Am Dent Assoc. 2015 Aug;146(8):610-622. doi: 10.1016/j.adaj.2015.02.011.

    PubMed 26227646

  • Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.

    PubMed 3485495

  • Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.

    PubMed 2524573

  • Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.

    PubMed 7806674

  • CHILTON NW. Studies in the design and analysis of dental experiments. II. A four-way analysis of variance. J Dent Res. 1960 Mar-Apr;39:344-60. doi: 10.1177/00220345600390021601. No abstract available.

    PubMed 13809868

  • Newman, MG, Takei, H, Klokkevold, PR, Carranza, FA; 2018; Newman and Carranza's Clinical Periodontology E-Book, 13th Edition; Saunders; p.387

  • Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.

    PubMed 5264376

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Colgate (R) Cavity Protection Toothpaste, Colgate (R) Cello Toothbrush and Prototype 1 Mouthwash in people with Gingivitis and Plaque, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in Canada.

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 14 inclusion and 18 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 13 Nov 2023. 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 Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use (time frame: After 12 weeks). The study lists 2 primary outcomes in all. 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 NCT05121909, which also lists 7 linked publications.

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 13 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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