Clinical trial NCT03421145: A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
Official title: A Prospective, Randomized, Blinded, Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Plaque
Keywords: Dental Plaque
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2018-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, blinded, clinical study to evaluate an oral rinse on plaque and gingivitis
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque Index Score Per Participant at 6 Months
timeFrame: 6 months
measure: Gingivitis Index Score Per Participant at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Plaque Index Score Per Participant at 3 Months
timeFrame: 3 months
measure: Bleeding Assessment Per Participant at 6 Months
timeFrame: 6 months
measure: Gingivitis Index Per Participant at 3 Months
timeFrame: 3 months
measure: Bleeding Index Per Participant at 3 Months
timeFrame: 3 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Dental Reserach
state: California
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 13. FDA FOI, 510(k) for Sinclair Pharmaceuticals PMA for Decapinol, Retrieved from http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHFOIAElectronicReadingRoom/UCM237296.pdf