PlaqueNCT03421145
A Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
A study testing 3M™ Oral Rinse, PerioShield™ Oral Health Rinse and Water in people with Plaque, run by Solventum US LLC at 1 site in United States.
Trial summary
Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque
- What is being tested?
- 3M™ Oral Rinse, PerioShield™ Oral Health Rinse and Water
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2017to 17 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda Dental Reserach
Loma Linda, California, 92350
About this study
Official title: A Prospective, Randomized, Blinded, Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
Rinse contains an anti-plaque agent that helps prevent the accumulation of dental plaque associated with gingivitis.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M™ Oral RinseDevice
Also called Plaque control 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).
Vehicle Control Oral RinseOther
Also called Placebo Comparator
The Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient.
PerioShield™ Oral Health RinseDevice
Also called Active Comparator
PerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study.
WaterOther
Also called Sham Comparator
Purified bottled water containing no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 3 months
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.
Measured: 6 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start17 Dec 2017
- Primary completion17 Jan 2019
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, blinded, clinical study to evaluate an oral rinse on plaque and gingivitis
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421145
- Sponsor's protocol ID
- EM-11-050003
- Status last verified
- Sep 2024
- First submitted
- 20 Dec 2017
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 108756892. 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.
PubMed 12974527Moran 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.
PubMed 9643238Steinberg 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.
PubMed 15163648Li 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.
PubMed 20437720LOE 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.
PubMed 14121956Talbott 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.
PubMed 275491QUIGLEY 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.
PubMed 14489483Turesky 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.
PubMed 5264376Lobene 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.
PubMed 6980082Caton 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.
PubMed 387168713. FDA FOI, 510(k) for Sinclair Pharmaceuticals PMA for Decapinol, Retrieved from http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHFOIAElectronicReadingRoom/UCM237296.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Blinded, Clinical Study to Evaluate Effects of an Oral Rinse on Plaque and Gingivitis
- ClinicalTrials.gov ID
- NCT03421145
- Acronym / sponsor ID
- EM-11-050003
- Conditions
- Plaque
- Keywords
- Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- 17 Dec 2017 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- prospective, randomized, blinded, clinical study to evaluate an oral rinse on plaque and gingivitis
| Arm | Type | Receives |
|---|---|---|
| 3M™ Oral Rinse | Experimental | Device: 3M™ Oral RinseSubjects 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 | Placebo comparator | Other: Vehicle Control Oral RinseVehicle 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. |
| PerioShield™ Oral Health Rinse | Active comparator | Device: PerioShield™ Oral Health RinseActive 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 comparator | Other: WaterWater 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects to whom these criteria apply will be entered into the 7-day washout
- 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.
Key exclusion criteria (16 listed)
- Subjects to whom these conditions apply will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3M™ Oral RinseAlso: Plaque control deviceThe 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). | Device | 3M™ Oral Rinse |
| Vehicle Control Oral RinseAlso: Placebo ComparatorThe Placebo Comparator oral rinse is similar to the Experimental Oral Rinse only it does not contain the active ingredient. | Other | Vehicle Control Oral Rinse |
| PerioShield™ Oral Health RinseAlso: Active ComparatorPerioShield™ Oral Health Rinse (0.2% delmopinol hydrochloride) is marketed in the US and was purchased for use in this study. | Device | PerioShield™ Oral Health Rinse |
| WaterAlso: Sham ComparatorPurified bottled water containing no active ingredients. | Other | Water |
Primary outcome
Plaque Index Score Per Participant at 6 Months
Time frame: 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.
Gingivitis Index Score Per Participant at 6 Months
Time frame: 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.
4 secondary outcomes
Plaque Index Score Per Participant at 3 Months
Time frame: 3 months
Bleeding Assessment Per Participant at 6 Months
Time frame: 6 months
Gingivitis Index Per Participant at 3 Months
Time frame: 3 months
Bleeding Index Per Participant at 3 Months
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10875689Parameter 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.
- Background2. 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: PubMed 12974527Baehni 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.
- Background: PubMed 9643238Moran 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.
- Background: PubMed 15163648Steinberg 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.
- Background: PubMed 20437720Li 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.
- Background: PubMed 14121956LOE 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.
- Background: PubMed 275491Talbott 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.
- Background: PubMed 14489483QUIGLEY 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.
- Background: PubMed 5264376Turesky 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.
- Background: PubMed 6980082Lobene 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.
- Background: PubMed 3871687Caton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M™ Oral Rinse, PerioShield™ Oral Health Rinse and Water in people with Plaque, run by Solventum US LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index Score Per Participant at 6 Months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03421145, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.