A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis

Solventum US LLC

Status: Completed

Conditions: Plaque

Treatments: Other: Vehicle Control Oral Rinse; Device: 3M™ Oral Rinse; Device: PerioShield™ Oral Health Rinse; Other: Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT03421145

EM-11-050003

Details and patient eligibility

About

Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis.

Full description

This is a prospective, single site, randomized, parallel, blinded clinical trial. Subjects will be randomly assigned to one of four treatment groups identified as Product A, Product B, Product C or Product D.

Subjects will be screened for eligibility and entered into a washout period that is at least 7 days, during which time they will be provided with study toothbrush, toothpaste and dental floss. No oral rinses or medication that alters oral tissue health will be used or taken during the washout period. After randomization, the designated rinse will be placed into a non-transparent container so that other subjects and clinical examiners do not see the allocated rinse per the randomization schedule.

Examinations for the clinical endpoints (PI, GI and BI) will be conducted at the baseline, 3-month, and 6-month visits.

Interim visits will be scheduled to review diary, replenish study supplies, check study compliance, etc. Subjects will be provided Colgate Regular toothpaste, dental floss and a soft toothbrush (replaced at 3 months) for use during the 6-month study period.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects to whom these criteria apply will be entered into the 7-day washout

  • Able to understand and willing to sign the Informed Consent
  • In good general health ages 18 and older
  • Have at least 20 natural teeth, including at least one molar and one premolar in each quadrant but excluding the third molars
  • Willing to return to the study facility for scheduled study visits and recalls
  • Agree not to use other oral hygiene products (non-study toothpaste, dental floss, mouth rinse, chewing gum)
  • Agree not to brush or floss teeth after 10:00 pm the night before and not eat or drink 4 hours before an appointment
  • Agree to the study instructions and visit schedule, including no eating or drinking for 4 hours before assessment appointments

Subjects must meet the screening inclusion criteria and these additional requirements for enrollment:

• Completed the washout period (at least 7 days) using only the study toothbrush, dental floss and toothpaste
• A qualifying baseline GI of at least 1.0, as determined by the Löe-Silness Gingival Index (GI)
• A qualifying baseline Modified Quigley-Hein (Lobene-Soparkar Modification of Turesky's modification) Plaque Index (PI) of at least 1.5 Subjects will be excluded if they do not meet the screening exclusion criteria.

Exclusion criteria

• Subjects to whom these conditions apply will be excluded:

  • A history of antibiotic therapy within the previous 30 days or have a condition that is likely to need antibiotic treatment over the course of the study (eg, cardiac conditions requiring antibiotic prophylaxis such as heart murmurs, pacemakers, or prosthetic heart valves, and prosthetic implants)
  • A history of using antimicrobial oral mouth rinse during the past 3 months
  • Taking medications which may alter gingival appearance/bleeding
  • Use of anticonvulsants, calcium channel blockers, or other medications with side effects known to impact oral health
  • Current participation in any other clinical study within the past 30 days
  • Reside in the same household with a subject already enrolled in the study
  • Dry mouth due to head/neck radiation therapy
  • Orthodontic appliances
  • Widespread caries or chronic neglect
  • Gross pathological changes of oral soft tissues
  • Known history of sensitivity to oral hygiene products
  • Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)
  • Pregnant or nursing or plan to become pregnant within the 6 month study duration
  • Medical and oral conditions that, in the investigator's judgment, may compromise the subject's safety or interfere with the conduct and outcome of the study
  • Difficult to be compliant with study visits, such as extensive travel commitments or lack of transportation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

3M™ Oral Rinse

Experimental group

Description:

Subjects assigned to the Experimental Oral Rinse ('Plaque control device) will swish a volume of 15 mL of the Experimental Rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.

Treatment:

Device: 3M™ Oral Rinse

Vehicle Control Oral Rinse

Placebo Comparator group

Description:

Vehicle control oral rinse (no active ingredient). Subjects assigned to the Placebo Comparator will swish a volume of 15 mL of the Placebo Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.

Treatment:

Other: Vehicle Control Oral Rinse

PerioShield™ Oral Health Rinse

Active Comparator group

Description:

Active control predicate device oral rinse ('Plaque control agent') Subjects assigned to the Active Comparator will swish a volume of 10 mL of the Active Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.

Treatment:

Device: PerioShield™ Oral Health Rinse

Water

Sham Comparator group

Description:

Water sham control oral rinse (not a Plaque control agent) Subjects assigned to the Sham Comparator will swish a volume of 15 mL of the Sham Comparator rinse for 30 seconds followed by expectoration, twice a day (morning and evening), after brushing teeth, for the 6-month duration of the study. They will use the dosing cup provided by the study team to ensure that the proper dose of rinse is used. Subjects will be instructed not to eat or drink for 30 minutes after using the rinse and to complete the subject daily diary.

Treatment:

Other: Water