HealthyPhase 4NCT04696536

A Twelve Week Study of Supervised Mouth Rinse and Flossing

A Phase 4 study testing Colgate Cavity Protection Toothpaste, American Dental Association (ADA) Referenced Toothbrush and 5% Hydroalcohol Mouth Rinse in people with Healthy, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy of twice daily alcohol containing essential oil mouth rinse and brushing versus dental flossing and brushing under once daily supervision for the prevention and reduction of plaque and gingivitis. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Colgate Cavity Protection Toothpaste, American Dental Association (ADA) Referenced Toothbrush and 5% Hydroalcohol Mouth Rinse
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 1 siteUnited States
Study dates: 26 Sep 2018to 21 Dec 2018
Phase: Phase 4
Are there results?: None posted in the registry

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

Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products according to instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
Able to attend once daily session during weekdays for flossing and rinsing occurring on site
Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
Able to read and understand the local language (participants capable of reading the documents)
Adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect)
A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
A minimum of 10 bleeding sites based on the BI
Absence of advanced periodontitis based on a clinical examination at Baseline and discretion of the dental examiner

Who cannot join

History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
Dental prophylaxis within four weeks prior to Screening/Baseline visit
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses within the two weeks prior to Baseline

Trial locations and contacts

1 site in 1 country.

United States1 site

Salus Research, Inc.
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis

Conditions: Healthy
Being tested: Colgate Cavity Protection Toothpaste, American Dental Association (ADA) Referenced Toothbrush, 5% Hydroalcohol Mouth Rinse, REACH Dental Floss, Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colgate Cavity Protection ToothpasteOther
Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
American Dental Association (ADA) Referenced ToothbrushOther
Participants will brush teeth at least one minute with provided toothbrush twice daily.
5% Hydroalcohol Mouth RinseOther
Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.
REACH Dental FlossOther
Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.
Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)Other
Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.

Study groups in NCT04696536
Study group	Role	What they receive
Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)	Experimental	Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Receives: Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Referenced Toothbrush; Other: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)
Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)	Experimental	Participants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home. Receives: Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Referenced Toothbrush; Other: 5% Hydroalcohol Mouth Rinse
Group 3: Flossing Performed by Dental Hygienist	Experimental	Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home. Receives: Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Referenced Toothbrush; Other: REACH Dental Floss
Group 4: Flossing under Supervision	Experimental	Participants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home. Receives: Other: Colgate Cavity Protection Toothpaste; Other: American Dental Association (ADA) Referenced Toothbrush; Other: REACH Dental Floss

What is being measured

The primary outcome is the main question the study is designed to answer.

Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Measured: 12 Weeks
Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2- Mild inflammation of the entire gingival unit; 3- Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4- Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: 12 Weeks

Secondary outcomes (7)

Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use
Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Measured: 4 Weeks
Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use
Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2- Mild inflammation of the entire gingival unit; 3- Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4- Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: 4 Weeks
Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use
Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Measured: 4 Weeks and 12 Weeks
Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use
Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2- Mild inflammation of the entire gingival unit; 3- Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4- Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.
Measured: 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use
Bleeding will be assessed according to the Gingival Bleeding Index. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 4 gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0- Absence of bleeding after 30 seconds; 1- Bleeding after 30 seconds; 2- Immediate bleeding.
Measured: 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use
Bleeding will be assessed according to the Gingival Bleeding Index. A periodontal probe with a 0.5 mm diameter tip will be inserted into the gingival crevice and swept from distal to mesial around the tooth at an angle of approximately 60 degree, while in contact with the sulcular epithelium. Each of 4 gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth will be assessed. After approximately 30 seconds, bleeding at each gingival unit will be recorded according to the following scale: 0- Absence of bleeding after 30 seconds; 1- Bleeding after 30 seconds; 2- Immediate bleeding.
Measured: 4 Weeks and 12 Weeks
Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks
Interproximal Plaque area will be assessed using the PMI on the facial and lingual surfaces. Distal proximal and mesial proximal will be assessed on all teeth including the distal of the second molar using the following scoring system: 0- No plaque; 1 - Separate flecks of plaque covering less than 1/3 of the area; 2 - Discrete areas or bands of plaque covering less than 1/3 of the area; 3 - Plaque covering 1/3 of the area; 4 - Plaque covering more than 1/3 but less than 2/3 of the area; 5 - Plaque covering 2/3 or more of the area.
Measured: 4 Weeks and 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 201821 Dec 2018

First posted6 Jan 2021
Study start26 Sep 2018
Primary completion21 Dec 2018
Study completion21 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04696536
Sponsor's protocol ID: CCSORC000708
Other IDs: CCSORC000708
Status last verified: Apr 2021
First submitted: 4 Jan 2021
Last updated: 28 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Publications

Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
PubMed 12699051
Marsh PD. Controlling the oral biofilm with antimicrobials. J Dent. 2010 Jun;38 Suppl 1:S11-5. doi: 10.1016/S0300-5712(10)70005-1.
PubMed 20621238
Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.
PubMed 12691269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study: Twelve Week Clinical Efficacy of Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
ClinicalTrials.gov ID: NCT04696536
Acronym / sponsor ID: CCSORC000708
Conditions: Healthy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 26 Sep 2018 (actual)
Primary completion: 21 Dec 2018 (actual)
Study completion: 21 Dec 2018 (actual)
First posted: 6 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 4

Arm	Type	Receives
Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)	Experimental	Other: Colgate Cavity Protection Toothpaste, Other: American Dental Association (ADA) Referenced Toothbrush, Other: Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)Participants will receive Alcohol-containing Essential Oil (AEO) containing mouth rinse (Listerine Cool Mint, marketed) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)	Experimental	Other: Colgate Cavity Protection Toothpaste, Other: American Dental Association (ADA) Referenced Toothbrush, Other: 5% Hydroalcohol Mouth RinseParticipants will receive negative control mouth rinse (5% Hydroalcohol mouth rinse) orally for 12 weeks. Participant will brush their teeth and rinse once daily under supervision during the week (five days) for 30 seconds with 20 milliliter (mL) of mouth rinse and brush their teeth and rinse a second time each day during the week at home. During the weekends, participants will brush twice daily in their usual manner, following rinsing with their assigned mouth rinse, unsupervised at home.
Group 3: Flossing Performed by Dental Hygienist	Experimental	Other: Colgate Cavity Protection Toothpaste, Other: American Dental Association (ADA) Referenced Toothbrush, Other: REACH Dental FlossParticipants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Dental hygienist will floss participant's teeth at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.
Group 4: Flossing under Supervision	Experimental	Other: Colgate Cavity Protection Toothpaste, Other: American Dental Association (ADA) Referenced Toothbrush, Other: REACH Dental FlossParticipants will brush their teeth and then undergo instructions on flossing technique using reach dental floss orally for 12 Weeks. Participants floss their teeth under supervision at the site once daily during the week (five days). The second brushing will be done unsupervised at home. The remaining weekend days flossing and brushing will be done unsupervised at home.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products according to instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
Able to attend once daily session during weekdays for flossing and rinsing occurring on site
Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
Able to read and understand the local language (participants capable of reading the documents)
Adequate oral hygiene (that is brush teeth daily and exhibit no signs or oral neglect)

Key exclusion criteria (5 listed)

History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye
Dental prophylaxis within four weeks prior to Screening/Baseline visit
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
Use of chemotherapeutic anti-plaque/anti-gingivitis products such as triclosan, essential oils, cetylpyridinium chloride, stannous fluoride or chlorhexidine containing mouth rinses within the two weeks prior to Baseline

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
Colgate Cavity Protection ToothpasteParticipants will use Colgate cavity protection toothpaste for brushing teeth twice daily.	Other	Group 1: Listerine Cool Mint Mouth Rinse (Marketed product), Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse), Group 3: Flossing Performed by Dental Hygienist, Group 4: Flossing under Supervision
American Dental Association (ADA) Referenced ToothbrushParticipants will brush teeth at least one minute with provided toothbrush twice daily.	Other	Group 1: Listerine Cool Mint Mouth Rinse (Marketed product), Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse), Group 3: Flossing Performed by Dental Hygienist, Group 4: Flossing under Supervision
5% Hydroalcohol Mouth RinseParticipants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.	Other	Group 2: Negative Control (5 Percent (%) Hydroalcohol Mouth Rinse)
REACH Dental FlossParticipants after brushing, rinse mouth with water and floss using Reach dental floss once a day.	Other	Group 3: Flossing Performed by Dental Hygienist, Group 4: Flossing under Supervision
Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.	Other	Group 1: Listerine Cool Mint Mouth Rinse (Marketed product)

Primary outcome

Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Time frame: 12 Weeks
Plaque area will be assessed using the Turesky Modification of the Quigley- Hein Plaque Index, on six surfaces (disto-buccal, mid-buccal, mesio-buccal and disto-lingual, mid-lingual, and mesio-lingual) of all scorable teeth, following disclosing: 0 - No plaque; 1 - Separate flecks or discontinuous band of plaque at the gingival (cervical0 margin); 2- Thin (up to 1 millimeter), continuous band of plaque at the gingival margin; 3 - Band of plaque wider than 1 mm but less than 1/3 of surface; 4 - Plaque covering 1/3, but less than 2/3 of surface; 5 - Plaque covering 2/3 or more of a surface.
Interproximal Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Time frame: 12 Weeks
Gingivitis will be assessed using Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0- Normal (absence of inflammation); 1- Mild inflammation (slight change in color, little change in texture) of any portion of the entire gingival unit; 2- Mild inflammation of the entire gingival unit; 3- Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4- Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.

7 secondary outcomes

Interproximal Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use
Time frame: 4 Weeks
Interproximal Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use
Time frame: 4 Weeks
Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Whole-mouth and Interproximal Percent Bleeding Sites, Based on the BI Score After 4 and 12 Weeks of Product use
Time frame: 4 Weeks and 12 Weeks
Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks
Time frame: 4 Weeks and 12 Weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Background: PubMed 12699051Bauroth K, Charles CH, Mankodi SM, Simmons K, Zhao Q, Kumar LD. The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis: a comparative study. J Am Dent Assoc. 2003 Mar;134(3):359-65. doi: 10.14219/jada.archive.2003.0167.
Background: PubMed 20621238Marsh PD. Controlling the oral biofilm with antimicrobials. J Dent. 2010 Jun;38 Suppl 1:S11-5. doi: 10.1016/S0300-5712(10)70005-1.
Background: PubMed 12691269Sharma NC, Charles CH, Qaqish JG, Galustians HJ, Zhao Q, Kumar LD. Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque. Am J Dent. 2002 Dec;15(6):351-5.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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.

Jeffery Milleman, DDS principal investigator

Salus Research, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 5 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 28 Sep 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Interproximal Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use (time frame: 12 Weeks). 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 NCT04696536, which also lists 3 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 28 Sep 2021.