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

Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421145
• Other study ID #: EM-11-050003
• Status: Completed
• Start date: December 17, 2017
• Est. completion date: January 17, 2019

Study information

• Verified date: September 2023
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 17, 2019
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Plaque

Intervention

Device:
• 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).

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

Device:
• 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.

Other:
• Water
Purified bottled water containing no active ingredients.

Locations

Country	Name	City	State
United States	Loma Linda Dental Reserach	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

References & Publications (13)

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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Index Score Per Participant at 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.	6 months
Primary	Gingivitis Index Score Per Participant at 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.	6 months
Secondary	Plaque Index Score Per Participant at 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.	3 months
Secondary	Bleeding Assessment Per Participant at 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.	6 months
Secondary	Gingivitis Index Per Participant at 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.	3 months
Secondary	Bleeding Index Per Participant at 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.	3 months