Back to resultsA Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
Primary Purpose
Plaque
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
3M™ Oral Rinse
Vehicle Control Oral Rinse
PerioShield™ Oral Health Rinse
Water
Sponsored by
About this trial
This is an interventional prevention trial for Plaque focused on measuring Dental Plaque
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
Sites / Locations
- Loma Linda Dental Reserach
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Active Comparator
Sham Comparator
Arm Label
3M™ Oral Rinse
Vehicle Control Oral Rinse
PerioShield™ Oral Health Rinse
Water
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03421145
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2017 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
January 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
3M
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque
Keywords
Dental Plaque
7. Study Design
Primary Purpose
Prevention
Interventional Study Model
Parallel Assignment
Model Description
prospective, randomized, blinded, clinical study to evaluate an oral rinse on plaque and gingivitis
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3M™ Oral Rinse
Arm Type
Experimental
Arm Description
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.
Arm Title
Vehicle Control Oral Rinse
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
PerioShield™ Oral Health Rinse
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Water
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3M™ Oral Rinse
Other Intervention Name(s)
Plaque control device
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Vehicle Control Oral Rinse
Other Intervention Name(s)
Placebo Comparator
Intervention Description
The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.
Intervention Type
Device
Intervention Name(s)
PerioShield™ Oral Health Rinse
Other Intervention Name(s)
Active Comparator
Intervention Description
PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.
Intervention Type
Other
Intervention Name(s)
Water
Other Intervention Name(s)
Sham Comparator
Intervention Description
Purified bottled water containing no active ingredients.
Primary Outcome Measure Information:
Title
Plaque Index Score Per Participant at 6 Months
Description
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.
Time Frame
6 months
Title
Gingivitis Index Score Per Participant at 6 Months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Plaque Index Score Per Participant at 3 Months
Description
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.
Time Frame
3 months
Title
Bleeding Assessment Per Participant at 6 Months
Description
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.
Time Frame
6 months
Title
Gingivitis Index Per Participant at 3 Months
Description
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.
Time Frame
3 months
Title
Bleeding Index Per Participant at 3 Months
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Loma Linda Dental Reserach
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10875689
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
12974527
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.
Results Reference
background
PubMed Identifier
9643238
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.
Results Reference
background
PubMed Identifier
15163648
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.
Results Reference
background
PubMed Identifier
20437720
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.
Results Reference
background
PubMed Identifier
14121956
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.
Results Reference
background
PubMed Identifier
275491
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.
Results Reference
background
PubMed Identifier
14489483
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.
Results Reference
background
PubMed Identifier
5264376
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.
Results Reference
background
PubMed Identifier
6980082
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.
Results Reference
background
PubMed Identifier
3871687
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.
Results Reference
background
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
Results Reference
background
Learn more about this trial
A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
We'll reach out to this number within 24 hrs