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Completed

NCT Number: NCT03421145

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

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

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Key information

Conditions

Plaque Dental Deposits Dental Plaque Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Loma Linda Dental Reserach

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3M™ Oral Rinse

Device

The Investigational Rinse contains a sugar-based surfactant using a proprietary formula. The intended use of the product is to help prevent and reduce plaque accumulation on the teeth and related gum-tissue inflammation (gingivitis).

Other names: Plaque control device

Vehicle Control Oral Rinse

Other

The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.

Other names: Placebo Comparator

PerioShield™ Oral Health Rinse

Device

PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.

Other names: Active Comparator

Water

Other

Purified bottled water containing no active ingredients.

Other names: Sham Comparator

Primary outcomes

  1. Plaque Index Score Per Participant at 6 Months

    Time frame: 6 months

    Modified Quigley-Hein Plaque Index 0 = No plaque

    • = Separate flecks of plaque at the cervical margin of the tooth
    • = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth.
    • = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth.
    • = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth.
    • = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure.

    The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.

  2. Gingivitis Index Score Per Participant at 6 Months

    Time frame: 6 months

    Löe-Silness Gingival Index

    0 = Absence of inflammation.

    • = Mild inflammation: slight change in color and little change in texture.
    • = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing.
    • = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding.

    The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.

Secondary outcomes

  1. Plaque Index Score Per Participant at 3 Months

    Time frame: 3 months

    Modified Quigley-Hein Plaque Index 0 = No plaque

    • = Separate flecks of plaque at the cervical margin of the tooth
    • = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth.
    • = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth.
    • = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth.
    • = Plaque covering 2/3 or more of the crown of the tooth. Each tooth is scored for supragingival plaque on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The PI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.

  2. Bleeding Assessment Per Participant at 6 Months

    Time frame: 6 months

    Eastman Interdental Bleeding Index 0 = Absence of bleeding.

    1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject.

  3. Gingivitis Index Per Participant at 3 Months

    Time frame: 3 months

    Löe-Silness Gingival Index

    0 = Absence of inflammation.

    • = Mild inflammation: slight change in color and little change in texture.
    • = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing.
    • = Severe inflammation: marked redness and hypertrophy. Tendency to spontaneous bleeding.

    The gingival surface surrounding each tooth (all natural teeth) will be scored on six surfaces: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Third molars and those teeth with cervical restorations or prosthetic crowns will be excluded from the scoring procedure. The GI score of the individual can be obtained by adding the scores of all surfaces and dividing by the number of surfaces examined.

  4. Bleeding Index Per Participant at 3 Months

    Time frame: 3 months

    Eastman Interdental Bleeding Index 0 = Absence of bleeding.

    1 = Presence of bleeding The interdental cleaner is inserted between two teeth from the facial aspect, depressing the interdental tissues 1 to 2 mm. This is repeated four times and the presence or absence of bleeding within 15 seconds is recorded. The absence or presence of bleeding will be recorded for each examined site (between two teeth), and a score will be calculated as the number of bleeding sites out of the number of examined sites for each evaluation on a subject.

Sponsors and collaborators

Lead sponsor

Solventum US LLC

Industry

Collaborators

  • 3M

Registry information

Official study title

A Prospective, Randomized, Blinded, Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2018
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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