GingivitisPhase 1NCT04921371
Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
A Phase 1 study testing Colgate® Cavity Protection Toothpaste, Listerine® Cool Mint® and Concept Curve Winter Series Toothbrush in people with Gingivitis and Plaque, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Plaque
- What is being tested?
- Colgate® Cavity Protection Toothpaste, Listerine® Cool Mint® and Concept Curve Winter Series Toothbrush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 19 Dec 2019
- Phase
- Phase 1
- 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
- Adequate oral hygiene (That is brush teeth daily and exhibit no signs or oral neglect)
- A minimum of 20 gradable teeth including 4 molars with scorable 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
- A mean gingival index greater than or equal to (>=) 1.95 per the Modified Gingival Index at Baseline (for those in the randomized treatment group)
- A mean gingival index less than or equals to (<=) 0.75 per the Modified Gingival Index at Baseline (for those in the healthy reference group)
- A mean plaque index >= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline (for those in randomized treatment groups)
- Greater than or equal to 10 percent (%) bleeding sites at baseline (for those in randomized treatment groups)
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 1 visit
- More than three sites that have periodontal pockets depths measuring 5mm or greater in depth
- Teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group)
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- 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 1 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.
About this study
Official title: Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.
- Conditions
- Gingivitis, Plaque
- Being tested
- Colgate® Cavity Protection Toothpaste, Listerine® Cool Mint®, Concept Curve Winter Series Toothbrush, 5% Hydroalcohol Mouthrinse, Mouthrinse Prototype 1
- Medical subject headings
- Gingivitis, Plaque, Amyloid
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.
Listerine® Cool Mint®Other
Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily.
Concept Curve Winter Series ToothbrushOther
Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
5% Hydroalcohol MouthrinseOther
Participants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily.
Mouthrinse Prototype 1Other
Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily.
Mouthrinse Prototype 2Other
Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Reference Group | Other | Participants who are identified as healthy will be a comparison group. This group will participate in the examinations and plaque sampling only and will not receive a prophylaxis or product. Receives: Other: Colgate® Cavity Protection Toothpaste; Other: Concept Curve Winter Series Toothbrush |
| 5% Hydroalcohol Mouthrinse (Negative control) | Experimental | Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 milliliter (mL) of 5 percent (%) Hydroalcohol Mouthrinse twice daily (morning and evening) up to 6 weeks. Receives: Other: Colgate® Cavity Protection Toothpaste; Other: Concept Curve Winter Series Toothbrush; Other: 5% Hydroalcohol Mouthrinse |
| Listerine® Cool Mint® (Positive control) | Experimental | Participants after brushing with Colgate® Cavity protection toothpaste and Concept curve winter series Toothbrush will rinse mouth for 30 seconds with 20 mL of Listerine® Cool Mint® twice daily (morning and evening) up to 6 weeks. Receives: Other: Colgate® Cavity Protection Toothpaste; Other: Listerine® Cool Mint®; Other: Concept Curve Winter Series Toothbrush |
| Mouthrinse Prototype 1 | Experimental | Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 mL of Mouthrinse Prototype 1 twice daily (morning and evening) up to 6 weeks. Receives: Other: Colgate® Cavity Protection Toothpaste; Other: Concept Curve Winter Series Toothbrush; Other: Mouthrinse Prototype 1 |
| Mouthrinse Prototype 2 | Experimental | Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 mL of Mouthrinse Prototype 2 twice daily (morning and evening) up to 6 weeks. Receives: Other: Colgate® Cavity Protection Toothpaste; Other: Concept Curve Winter Series Toothbrush; Other: Mouthrinse Prototype 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-mouth Mean Modified Gingival Index (Mean MGI) 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 Plaque Index (Mean PI) After 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: 6 weeks
Secondary outcomes (4)
Whole-mouth Mean Plaque Index (Mean PI) After 4 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: 4 weeks
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 4 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: 4 weeks
Whole-mouth Mean Expanded Bleeding Index (Mean BI) After 4 and 6 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: 4 and 6 Weeks
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index After 4 and 6 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: 4 and 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start8 Oct 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Milleman, DDS, Principal investigator, Salus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04921371
- Sponsor's protocol ID
- CCSORC001793
- Other IDs
- CCSORC001793
- Status last verified
- Sep 2023
- First submitted
- 4 Jun 2021
- Last updated
- 28 Sep 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
Min K, Glowacki AJ, Bosma ML, McGuire JA, Tian S, McAdoo K, DelSasso A, Fourre T, Gambogi RJ, Milleman J, Milleman KR. Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial. BMC Oral Health. 2024 May 18;24(1):578. doi: 10.1186/s12903-024-04365-9.
PubMed 38762482
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
- ClinicalTrials.gov ID
- NCT04921371
- Acronym / sponsor ID
- CCSORC001793
- Conditions
- Gingivitis, Plaque
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 10 Jun 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.
The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Reference Group | Other | Other: Colgate® Cavity Protection Toothpaste, Other: Concept Curve Winter Series ToothbrushParticipants who are identified as healthy will be a comparison group. This group will participate in the examinations and plaque sampling only and will not receive a prophylaxis or product. |
| 5% Hydroalcohol Mouthrinse (Negative control) | Experimental | Other: Colgate® Cavity Protection Toothpaste, Other: Concept Curve Winter Series Toothbrush, Other: 5% Hydroalcohol MouthrinseParticipants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 milliliter (mL) of 5 percent (%) Hydroalcohol Mouthrinse twice daily (morning and evening) up to 6 weeks. |
| Listerine® Cool Mint® (Positive control) | Experimental | Other: Colgate® Cavity Protection Toothpaste, Other: Listerine® Cool Mint®, Other: Concept Curve Winter Series ToothbrushParticipants after brushing with Colgate® Cavity protection toothpaste and Concept curve winter series Toothbrush will rinse mouth for 30 seconds with 20 mL of Listerine® Cool Mint® twice daily (morning and evening) up to 6 weeks. |
| Mouthrinse Prototype 1 | Experimental | Other: Colgate® Cavity Protection Toothpaste, Other: Concept Curve Winter Series Toothbrush, Other: Mouthrinse Prototype 1Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 mL of Mouthrinse Prototype 1 twice daily (morning and evening) up to 6 weeks. |
| Mouthrinse Prototype 2 | Experimental | Other: Colgate® Cavity Protection Toothpaste, Other: Concept Curve Winter Series Toothbrush, Other: Mouthrinse Prototype 2Participants after brushing with Colgate® Cavity protection toothpaste and Concept Curve winter series toothbrush will rinse mouth for 30 seconds with 20 mL of Mouthrinse Prototype 2 twice daily (morning and evening) up to 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adequate oral hygiene (That is brush teeth daily and exhibit no signs or oral neglect)
- A minimum of 20 gradable teeth including 4 molars with scorable 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
- A mean gingival index greater than or equal to (>=) 1.95 per the Modified Gingival Index at Baseline (for those in the randomized treatment group)
- A mean gingival index less than or equals to (<=) 0.75 per the Modified Gingival Index at Baseline (for those in the healthy reference group)
- A mean plaque index >= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline (for those in randomized treatment groups)
Key exclusion criteria (6 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 1 visit
- More than three sites that have periodontal pockets depths measuring 5mm or greater in depth
- Teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group)
- History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
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 | 5% Hydroalcohol Mouthrinse (Negative control), Healthy Reference Group, Listerine® Cool Mint® (Positive control), Mouthrinse Prototype 1, Mouthrinse Prototype 2 |
| Listerine® Cool Mint®Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily. | Other | Listerine® Cool Mint® (Positive control) |
| Concept Curve Winter Series ToothbrushParticipants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided. | Other | 5% Hydroalcohol Mouthrinse (Negative control), Healthy Reference Group, Listerine® Cool Mint® (Positive control), Mouthrinse Prototype 1, Mouthrinse Prototype 2 |
| 5% Hydroalcohol MouthrinseParticipants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily. | Other | 5% Hydroalcohol Mouthrinse (Negative control) |
| Mouthrinse Prototype 1Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily. | Other | Mouthrinse Prototype 1 |
| Mouthrinse Prototype 2Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily. | Other | Mouthrinse Prototype 2 |
Primary outcome
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 6 Weeks of Product Use
Time frame: 6 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 Plaque Index (Mean PI) After 6 Weeks of Product Use
Time frame: 6 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 Plaque Index (Mean PI) After 4 Weeks of Product Use
Time frame: 4 weeks
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 4 Weeks of Product Use
Time frame: 4 weeks
Whole-mouth Mean Expanded Bleeding Index (Mean BI) After 4 and 6 Weeks of Product Use
Time frame: 4 and 6 Weeks
Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index After 4 and 6 Weeks of Product Use
Time frame: 4 and 6 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 2023.
- Derived from this study: PubMed 38762482Min K, Glowacki AJ, Bosma ML, McGuire JA, Tian S, McAdoo K, DelSasso A, Fourre T, Gambogi RJ, Milleman J, Milleman KR. Quantitative analysis of the effects of essential oil mouthrinses on clinical plaque microbiome: a parallel-group, randomized trial. BMC Oral Health. 2024 May 18;24(1):578. doi: 10.1186/s12903-024-04365-9.
- 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.
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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.
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?
A Phase 1 study testing Colgate® Cavity Protection Toothpaste, Listerine® Cool Mint® and Concept Curve Winter Series Toothbrush in people with Gingivitis and Plaque, run by Johnson & Johnson Consumer Inc. (J&JCI) 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 6 inclusion and 6 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (Mean MGI) After 6 Weeks of Product Use (time frame: 6 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 NCT04921371, which also lists 1 linked publication.
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 2023.