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

NCT03421145 | Completed Results

• 1 other identifier: EM-11-050003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Plaque

Keywords

Dental Plaque

Outcome Measures

Primary Outcomes (2)

• Plaque Index Score Per Participant at 6 Months

  Modified Quigley-Hein Plaque Index 0 = No plaque 1. = Separate flecks of plaque at the cervical margin of the tooth 2. = A thin, continuous band of plaque (up to one mm) at the cervical margin of the tooth. 3. = A band of plaque wider than 1 mm, but covering less than 1/3 of the crown of the tooth. 4. = Plaque covering at least 1/3, but less than 2/3 of the crown of the tooth. 5. = 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.

  6 months

• Gingivitis Index Score Per Participant at 6 Months

  Löe-Silness Gingival Index 0 = Absence of inflammation. 1. = Mild inflammation: slight change in color and little change in texture. 2. = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing. 3. = 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.

  6 months

Secondary Outcomes (4)

• Plaque Index Score Per Participant at 3 Months

  3 months

• Bleeding Assessment Per Participant at 6 Months

  6 months

• Gingivitis Index Per Participant at 3 Months

  3 months

• Bleeding Index Per Participant at 3 Months

  3 months

Study Arms (4)

3M™ Oral Rinse

EXPERIMENTAL

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.

Device: 3M™ Oral Rinse

Vehicle Control Oral Rinse

PLACEBO COMPARATOR

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.

Other: Vehicle Control Oral Rinse

PerioShield™ Oral Health Rinse

ACTIVE COMPARATOR

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.

Device: PerioShield™ Oral Health Rinse

Water

SHAM COMPARATOR

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.

Other: Water

Interventions

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).

Also known as: Plaque control device

3M™ Oral Rinse

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.

Also known as: Placebo Comparator

Vehicle Control Oral Rinse

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.

Also known as: Active Comparator

PerioShield™ Oral Health Rinse

Water OTHER

Purified bottled water containing no active ingredients.

Also known as: Sham Comparator

Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

Loma Linda Dental Reserach

Loma Linda, California, 92350, United States

Location

Related Publications (13)

• Parameter on plaque-induced gingivitis. American Academy of Periodontology. J Periodontol. 2000 May;71(5 Suppl):851-2. doi: 10.1902/jop.2000.71.5-S.851.

  PMID: 10875689 BACKGROUND

• 2. National Institute of Health and Clinical Excellence (NICE). Dental recall interval between routine dental examinations. http://guidance.nice.org.uk/CG19 Clinical Guideline 19; 2004.

  BACKGROUND

• Baehni PC, Takeuchi Y. Anti-plaque agents in the prevention of biofilm-associated oral diseases. Oral Dis. 2003;9 Suppl 1:23-9. doi: 10.1034/j.1601-0825.9.s1.5.x.

  PMID: 12974527 BACKGROUND

• Moran JM. Chemical plaque control--prevention for the masses. Periodontol 2000. 1997 Oct;15:109-17. doi: 10.1111/j.1600-0757.1997.tb00110.x. No abstract available.

  PMID: 9643238 BACKGROUND

• Steinberg D, Feldman M, Ofek I, Weiss EI. Effect of a high-molecular-weight component of cranberry on constituents of dental biofilm. J Antimicrob Chemother. 2004 Jul;54(1):86-9. doi: 10.1093/jac/dkh254. Epub 2004 May 26.

  PMID: 15163648 BACKGROUND

• Li Y, Lee S, Hujoel P, Su M, Zhang W, Kim J, Zhang YP, DeVizio W. Prevalence and severity of gingivitis in American adults. Am J Dent. 2010 Feb;23(1):9-13.

  PMID: 20437720 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Talbott K, Mandel ID, Chilton NW. Reduction of baseline gingivitis scores with repeated prophylaxes. J Prev Dent. 1977 Nov-Dec;4(6):28-9. No abstract available.

  PMID: 275491 BACKGROUND

• QUIGLEY GA, HEIN JW. Comparative cleansing efficiency of manual and power brushing. J Am Dent Assoc. 1962 Jul;65:26-9. doi: 10.14219/jada.archive.1962.0184. No abstract available.

  PMID: 14489483 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

• Lobene RR, Soparkar PM, Newman MB. Use of dental floss. Effect on plaque and gingivitis. Clin Prev Dent. 1982 Jan-Feb;4(1):5-8. No abstract available.

  PMID: 6980082 BACKGROUND

• Caton JG, Polson AM. The interdental bleeding index: a simplified procedure for monitoring gingival health. Compend Contin Educ Dent (Lawrenceville). 1985 Feb;6(2):88, 90-2. No abstract available.

  PMID: 3871687 BACKGROUND

• 13. FDA FOI, 510(k) for Sinclair Pharmaceuticals PMA for Decapinol, Retrieved from http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHFOIAElectronicReadingRoom/UCM237296.pdf

  BACKGROUND

MeSH Terms

Conditions

Plaque, Amyloid; Dental Plaque

Interventions

Water

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Manager of Biostatistics
• Organization: 3M Health Care Business Group

swalters@mmm.com

6518152737

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Principal Investigator and clinical examiners will be blinded to the treatment products. No clinical examiners will see the allocated rinse assigned per the randomization schedule.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: prospective, randomized, blinded, clinical study to evaluate an oral rinse on plaque and gingivitis

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: February 5, 2018
• Study Start: December 17, 2017
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: October 1, 2024
• Results First Posted: September 28, 2023

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)