A Study of Experimental Mouthwashes

NCT05121909 | Completed Phase 4

• 1 other identifier: CCSORC004216
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis; Plaque

Outcome Measures

Primary Outcomes (2)

• 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.

  After 12 weeks

• 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.

  After 12 weeks

Secondary Outcomes (6)

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

  After 1 and 4 weeks

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

  After 1 and 4 weeks

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

  1, 4 and 12 weeks

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

  1, 4 and 12 weeks

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

  After 4 and 12 weeks

Study Arms (5)

Prototype 1 Mouthwash

EXPERIMENTAL

Participants 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.

Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: Prototype 1 Mouthwash

Prototype 2 Mouthwash

EXPERIMENTAL

Participants 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.

Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: Prototype 2 Mouthwash

Prototype 3 Mouthwash

EXPERIMENTAL

Participants 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.

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 COMPARATOR

Participants 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.

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 COMPARATOR

Participants 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.

Other: Colgate (R) Cavity Protection Toothpaste; Device: Colgate (R) Cello Toothbrush; Other: 5% Hydroalcohol Mouthwash

Interventions

Colgate (R) Cavity Protection Toothpaste OTHER

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

5 Percent (%) Hydroalcohol Mouthwash (Negative Control); Listerine (R) Cool Mint (R) Antiseptic Mouthwash (Positive Control); Prototype 1 Mouthwash; Prototype 2 Mouthwash; Prototype 3 Mouthwash

Colgate (R) Cello Toothbrush DEVICE

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

5 Percent (%) Hydroalcohol Mouthwash (Negative Control); Listerine (R) Cool Mint (R) Antiseptic Mouthwash (Positive Control); Prototype 1 Mouthwash; Prototype 2 Mouthwash; Prototype 3 Mouthwash

Prototype 1 Mouthwash OTHER

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

Prototype 1 Mouthwash

Prototype 2 Mouthwash OTHER

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

Prototype 2 Mouthwash

Prototype 3 Mouthwash OTHER

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

Prototype 3 Mouthwash

Listerine (R) Cool Mint (R) Antiseptic Mouthwash OTHER

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

Listerine (R) Cool Mint (R) Antiseptic Mouthwash (Positive Control)

5% Hydroalcohol Mouthwash OTHER

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

5 Percent (%) Hydroalcohol Mouthwash (Negative Control)

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

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

Mississauga, Ontario, Canada, L5N 6J2, Canada

Location

Related Publications (7)

• 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.

  PMID: 26227646 BACKGROUND

• 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.

  PMID: 3485495 BACKGROUND

• 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.

  PMID: 2524573 BACKGROUND

• 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.

  PMID: 7806674 BACKGROUND

• 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.

  PMID: 13809868 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 5264376 BACKGROUND

Related Links

• Twelve Week Safety/Clinical/Microbiological Efficacy of Experimental Mouthwashes

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Interventions

Sodium Fluoride; Listerine

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Chhaju Ram Goyal, DDS

  All Sum Research Center Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 16, 2021
• Study Start: November 15, 2021
• Primary Completion: April 14, 2022
• Study Completion: April 14, 2022
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)