A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
NCT ID: NCT03421145
Last Updated: 2024-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
200 participants
INTERVENTIONAL
2017-12-17
2019-01-17
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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3M™ Oral Rinse
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.
3M™ Oral Rinse
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).
Vehicle Control Oral Rinse
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.
Vehicle Control Oral Rinse
The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.
PerioShield™ Oral Health Rinse
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.
PerioShield™ Oral Health Rinse
PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.
Water
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.
Water
Purified bottled water containing no active ingredients.
Interventions
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3M™ Oral Rinse
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).
Vehicle Control Oral Rinse
The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.
PerioShield™ Oral Health Rinse
PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.
Water
Purified bottled water containing no active ingredients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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3M
INDUSTRY
Solventum US LLC
INDUSTRY
Responsible Party
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Locations
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Loma Linda Dental Reserach
Loma Linda, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
13. FDA FOI, 510(k) for Sinclair Pharmaceuticals PMA for Decapinol, Retrieved from http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHFOIAElectronicReadingRoom/UCM237296.pdf
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Protocol with planned Statistical Analysis Plan
Document Type: Statistical Analysis Plan: Detailed Statistical Analysis Plan
Other Identifiers
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EM-11-050003
Identifier Type: -
Identifier Source: org_study_id
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