Gingivits in DiabeticsPhase 4NCT04449952

A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants

A Phase 4 study testing Listerine Cool Mint, 5% Hydroalcohol Mouth Rinse and Colgate Cavity Protection Toothpaste in people with Gingivits in Diabetics, 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

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Trial summary

The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2 diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week treatment period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gingivits in Diabetics
What is being tested?: Listerine Cool Mint, 5% Hydroalcohol Mouth Rinse and Colgate Cavity Protection Toothpaste
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 154 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2019to 6 Mar 2020
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
Negative pregnancy urine tests (females of child bearing potential only)
Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
A minimum of 20 gradable teeth including 4 molars with scorable both facial and lingual surfaces.Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count
Diabetes Type 1 or Type 2-self reported

Show all 9Show fewer

An HB A1C level less than (<) 7.0 percent (%) for Type 1 Diabetes and an HB A1C level of <8.0% for Type 2 Diabetes
A mean gingival index greater than or equal to (>=) 1.85 per the Modified Gingival Index at Baseline
A mean plaque index >= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline

Who cannot join

Dental prophylaxis within four weeks prior to baseline visit
More than 3 sites having pocket depths of 5 millimeter (mm) or any sites that are greater than 5 mm in depth
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
A recent history of hypoglycemia requiring medical intervention within the past 30 days
Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators 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

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: Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis

Conditions: Gingivits in Diabetics
Being tested: Listerine Cool Mint, 5% Hydroalcohol Mouth Rinse, Colgate Cavity Protection Toothpaste, Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula, Concept Curve Winter Series Toothbrush

What participants receive

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

Listerine Cool MintOther
Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing
5% Hydroalcohol Mouth RinseOther
Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.
Colgate Cavity Protection ToothpasteOther
Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead FormulaOther
Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.
Concept Curve Winter Series ToothbrushDevice
Participants will brush teeth at least one minute with provided bristled toothbrush.
Listerine Cool Mint FlossDevice
Participants will use marketed fluoride-containing dentifrice, floss.

Study groups in NCT04449952
Study group	Role	What they receive
AFEO-Containing Mouth Rinse	Experimental	Participants with Diabetes (Type 1 and 2) will be randomized to receive AFEO-containing mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 milliliter (mL) of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks. Receives: Other: Colgate Cavity Protection Toothpaste; Other: Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula; Device: Concept Curve Winter Series Toothbrush; Device: Listerine Cool Mint Floss
Listerine Cool Mint Mouth Rinse (Marketed product)	Experimental	Participants with Diabetes (Type 1 and 2) will be randomized to receive Listerine cool mint mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks. Receives: Other: Listerine Cool Mint; Other: Colgate Cavity Protection Toothpaste; Device: Concept Curve Winter Series Toothbrush; Device: Listerine Cool Mint Floss
5 Percent (%) Hydroalcohol Mouth Rinse	Experimental	Participants with Diabetes (Type 1 and 2) will be randomized to receive 5% Hydroalcohol mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks. Receives: Other: 5% Hydroalcohol Mouth Rinse; Other: Colgate Cavity Protection Toothpaste; Device: Concept Curve Winter Series Toothbrush; Device: Listerine Cool Mint Floss

What is being measured

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

Whole-Mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Gingivitis will be assessed by the 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
Whole Mouth Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
Measured: 12 Weeks

Secondary outcomes (4)

Whole Mouth Mean Turesky Plaque Index (TPI) Score After 1 and 6 Weeks of Product use
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
Measured: 1 Week and 6 Weeks
Whole-Mouth Mean Modified Gingival Index (MGI) Score After 6 Weeks of Product use
Gingivitis will be assessed by the 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: 6 Weeks
Whole-Mouth Mean Expanded Bleeding Index (EBI) Score After 6 and 12 Weeks of Product use
Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (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 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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: 6 Weeks and 12 Weeks
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index Score After 6 and 12 Weeks of Product use
Percent bleeding sites will be calculated by taking the total number of sites with bleeding score greater than 0 divided by the total number of sites assessed for each participant. Bleeding will be assessed according to the Expanded Gingival Bleeding Index, 168 Sites. A periodontal probe with a 0.5 millimeter (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 6 gingival areas (distobuccal, mid-buccal, mesiobuccal, distolingual, 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: 6 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.

2 Dec 20196 Mar 2020

First posted29 Jun 2020
Study start2 Dec 2019
Primary completion6 Mar 2020
Study completion6 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gingivits in DiabeticsStudies 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: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04449952
Sponsor's protocol ID: CCSORC002281
Other IDs: CCSORC002281
Status last verified: Jul 2023
First submitted: 24 Jun 2020
Last updated: 7 Aug 2023
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

Leite RS, Marlow NM, Fernandes JK, Hermayer K. Oral health and type 2 diabetes. Am J Med Sci. 2013 Apr;345(4):271-273. doi: 10.1097/MAJ.0b013e31828bdedf.
PubMed 23531957
Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Fitterman N, Balzer K, Boyd C, Humphrey LL, Iorio A, Lin J, Maroto M, McLean R, Mustafa R, Tufte J. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians. Ann Intern Med. 2018 Apr 17;168(8):569-576. doi: 10.7326/M17-0939. Epub 2018 Mar 6.
PubMed 29507945

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Clinical Efficacy of Mouth Rinses in Type 1 and Type 2 Diabetics: Effect on Oral Soft Tissue, Plaque and Gingivitis
ClinicalTrials.gov ID: NCT04449952
Acronym / sponsor ID: CCSORC002281
Conditions: Gingivits in Diabetics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
Study start: 2 Dec 2019 (actual)
Primary completion: 6 Mar 2020 (actual)
Study completion: 6 Mar 2020 (actual)
First posted: 29 Jun 2020 (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: 3

Arm	Type	Receives
AFEO-Containing Mouth Rinse	Experimental	Other: Colgate Cavity Protection Toothpaste, Other: Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula, Device: Concept Curve Winter Series Toothbrush, Device: Listerine Cool Mint FlossParticipants with Diabetes (Type 1 and 2) will be randomized to receive AFEO-containing mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 milliliter (mL) of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
Listerine Cool Mint Mouth Rinse (Marketed product)	Experimental	Other: Listerine Cool Mint, Other: Colgate Cavity Protection Toothpaste, Device: Concept Curve Winter Series Toothbrush, Device: Listerine Cool Mint FlossParticipants with Diabetes (Type 1 and 2) will be randomized to receive Listerine cool mint mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.
5 Percent (%) Hydroalcohol Mouth Rinse	Experimental	Other: 5% Hydroalcohol Mouth Rinse, Other: Colgate Cavity Protection Toothpaste, Device: Concept Curve Winter Series Toothbrush, Device: Listerine Cool Mint FlossParticipants with Diabetes (Type 1 and 2) will be randomized to receive 5% Hydroalcohol mouth rinse with a marketed fluoride-containing dentifrice, floss (if flossing is part of their normal oral care routine), a marketed soft bristled toothbrush and a timer (if needed). They will brush for at least one minute using full ribbon of a marketed toothpaste on the provided toothbrush. After brushing, rinse for 30 seconds with 20 mL of the assigned mouth rinse twice daily (morning and evening) for 12 consecutive Weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
Able to comprehend and follow the requirements and restrictions of the study (including willingness to use the assigned study products per instructions, availability on scheduled visit dates and likeliness of completing the clinical study) based upon research site personnel's assessment
Negative pregnancy urine tests (females of child bearing potential only)
Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
A minimum of 20 gradable teeth including 4 molars with scorable both facial and lingual surfaces.Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count

Key exclusion criteria (5 listed)

Dental prophylaxis within four weeks prior to baseline visit
More than 3 sites having pocket depths of 5 millimeter (mm) or any sites that are greater than 5 mm in depth
History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
A recent history of hypoglycemia requiring medical intervention within the past 30 days
Use of antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators 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

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
Listerine Cool MintParticipants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing	Other	Listerine Cool Mint Mouth Rinse (Marketed product)
5% Hydroalcohol Mouth RinseParticipants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.	Other	5 Percent (%) Hydroalcohol Mouth Rinse
Colgate Cavity Protection ToothpasteParticipants used Colgate cavity protection toothpaste for brushing teeth twice daily.	Other	5 Percent (%) Hydroalcohol Mouth Rinse, AFEO-Containing Mouth Rinse, Listerine Cool Mint Mouth Rinse (Marketed product)
Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead FormulaParticipants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.	Other	AFEO-Containing Mouth Rinse
Concept Curve Winter Series ToothbrushParticipants will brush teeth at least one minute with provided bristled toothbrush.	Device	5 Percent (%) Hydroalcohol Mouth Rinse, AFEO-Containing Mouth Rinse, Listerine Cool Mint Mouth Rinse (Marketed product)
Listerine Cool Mint FlossParticipants will use marketed fluoride-containing dentifrice, floss.	Device	5 Percent (%) Hydroalcohol Mouth Rinse, AFEO-Containing Mouth Rinse, Listerine Cool Mint Mouth Rinse (Marketed product)

Primary outcome

Whole-Mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
Time frame: 12 Weeks
Gingivitis will be assessed by the 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).
Whole Mouth Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
Time frame: 12 Weeks
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter [mm]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).

4 secondary outcomes

Whole Mouth Mean Turesky Plaque Index (TPI) Score After 1 and 6 Weeks of Product use
Time frame: 1 Week and 6 Weeks
Whole-Mouth Mean Modified Gingival Index (MGI) Score After 6 Weeks of Product use
Time frame: 6 Weeks
Whole-Mouth Mean Expanded Bleeding Index (EBI) Score After 6 and 12 Weeks of Product use
Time frame: 6 Weeks and 12 Weeks
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index Score After 6 and 12 Weeks of Product use
Time frame: 6 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 7 Aug 2023.
Background: PubMed 23531957Leite RS, Marlow NM, Fernandes JK, Hermayer K. Oral health and type 2 diabetes. Am J Med Sci. 2013 Apr;345(4):271-273. doi: 10.1097/MAJ.0b013e31828bdedf.
Background: PubMed 29507945Qaseem A, Wilt TJ, Kansagara D, Horwitch C, Barry MJ, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Fitterman N, Balzer K, Boyd C, Humphrey LL, Iorio A, Lin J, Maroto M, McLean R, Mustafa R, Tufte J. Hemoglobin A1c Targets for Glycemic Control With Pharmacologic Therapy for Nonpregnant Adults With Type 2 Diabetes Mellitus: A Guidance Statement Update From the American College of Physicians. Ann Intern Med. 2018 Apr 17;168(8):569-576. doi: 10.7326/M17-0939. Epub 2018 Mar 6.
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.

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 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 9 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 7 Aug 2023. 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?

Whole-Mouth Mean Modified Gingival Index (MGI) 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 NCT04449952, which also lists 2 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 7 Aug 2023.