GingivitisPhase 4NCT03219840
Cetylpyridium Chloride (CPC) Based Chewing Gum and Gingivitis
A Phase 4 study testing Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and Xylitol only chewing gum in people with Gingivitis and Plaque, Dental, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. 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, Dental, Periodontal Diseases
- What is being tested?
- Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and Xylitol only chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 8 Sep 2018
- Phase
- Phase 4
- 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
- Be aged 18 and older
- Be capable of giving informed consent themselves and are able and willing to participate in the study
- Patients willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
- Patients that regularly brush their teeth twice a day
Who cannot join
- Pregnant or breastfeeding women
- Patients taking long-term anti-microbial or anti-inflammatory drugs
- Patients unable or unwilling to provide informed consent
- Self-reported use of tobacco products
- Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity
- Less than 26 teeth in the mouth
Show all 9Show fewer
- Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study
- Periodontitis as indicated periodontal pockets greater than 5 millimeters on more than one site
- Inability to comply with assigned treatment regimen
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
About this study
Official title: Effects of Cetylpyridium Chloride (CPC) Based Chewing Gum Plus Tooth Brushing on Plaque Formation and Gingivitis: a Randomized, Double-Blind, Crossover, Placebo-controlled Clinical Trial
This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum in the second treatment period (21 days). The other half will be assigned to follow the same schedule but with the treatment reversed. A statistician will perform the randomization. Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival Index (GI), and percent of bleeding sites on probe (BOP).
- Conditions
- Gingivitis, Plaque, Dental, Periodontal Diseases
- Being tested
- Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum, Xylitol only chewing gum
- Keywords
- Cetylpyridium Chloride (CPC), Chewing Gum
- Medical subject headings
- Gingivitis, Dental Plaque, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gumDrug
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
Xylitol only chewing gumDrug
All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
| Study group | Role | What they receive |
|---|---|---|
| CPC + Xylitol chewing gum, then Xylitol only chewing gum | Experimental | Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and then Xylitol only chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Xylitol only chewing gum will be used for the last 21 days. Receives: Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum; Drug: Xylitol only chewing gum |
| Xylitol only chewing gum, then CPC + Xylitol chewing gum | Experimental | Xylitol only chewing gum and then Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Xylitol only chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the last 21 days. Receives: Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum; Drug: Xylitol only chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated.
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 one mm but covering less than one-third of the crown of the tooth
- Plaque covering at least one-third but less than two-thirds of the crown of the tooth
- Plaque covering two-thirds or more of the crown of the tooth
Measured: day 1
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated.
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 one mm but covering less than one-third of the crown of the tooth
- Plaque covering at least one-third but less than two-thirds of the crown of the tooth
- Plaque covering two-thirds or more of the crown of the tooth
Measured: day 22
Degree of Gingivitis as Assessed by the Gingival Index (GI)
Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated.
0 Absence of inflammation.
- Mild inflammation - slight change in color and little change in texture.
- Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure.
- Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Measured: day 1
Degree of Gingivitis as Assessed by the Gingival Index (GI)
Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated.
0 Absence of inflammation.
- Mild inflammation - slight change in color and little change in texture.
- Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure.
- Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Measured: day 22
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Bleeding on probing (BOP) as described in Ainamo \& Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for the 4 gingival areas is calculated.
0 Absence of bleeding after 30 seconds
- Bleeding after 30 seconds
- Immediate bleeding
Measured: day 1
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Bleeding on probing (BOP) as described in Ainamo \& Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for all teeth is calculated, an average of the scores for the 4 gingival areas is calculated.
0 Absence of bleeding after 30 seconds
- Bleeding after 30 seconds
- Immediate bleeding
Measured: day 22
Secondary outcomes (2)
Discoloration of Teeth as Assessed by the Vita Scale
Objective observation of Discoloration of teeth will be recorded using a Vita scale. The color of the participant's teeth is matched to the colors on the scale. The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration.
Measured: day 1
Discoloration of Teeth as Assessed by the Vita Scale
Objective observation of Discoloration of teeth will be recorded using a Vita scale. The color of the participant's teeth is matched to the colors on the scale. The colors in the scale are A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4--the letter portion of the scale indicates a tooth color of reddish-brownish (A), reddish-yellowish (B), greyish (C), or reddish-grey (D), and the number portion of the scale indicates degree of discoloration, with 1 indicating least discoloration and 4 indicating the most discoloration.
Measured: day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start18 Oct 2017
- Primary completion8 Sep 2018
- Study completion8 Sep 2018
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.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CONFADENT Oral Technology, Kiss Industries LLC
- Responsible party
- Sponsor
- Investigators
- Flavia Lakschevitz, DDS, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219840
- Sponsor's protocol ID
- HSC-DB-17-0313
- Status last verified
- Jan 2021
- First submitted
- 13 Jul 2017
- Last updated
- 8 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cetylpyridium Chloride (CPC) Based Chewing Gum Plus Tooth Brushing on Plaque Formation and Gingivitis: a Randomized, Double-Blind, Crossover, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03219840
- Acronym / sponsor ID
- HSC-DB-17-0313
- Conditions
- Gingivitis, Plaque, Dental, Periodontal Diseases
- Keywords
- Cetylpyridium Chloride (CPC), Chewing Gum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- CONFADENT Oral Technology, Kiss Industries LLC
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 8 Sep 2018 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 8 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This placebo-controlled, double-blinded, randomized crossover study evaluates the plaque and gingivitis reducing capacity of Cetylpyridium Chloride (CPC) chewing gum, with mechanical oral hygiene. The study will enroll 73 students, faculty, and staff from the UTHealth School of Dentistry. Half of the eligible participants will be randomly assigned to get the CPC gum in the first treatment period (21 days), a wash-out period of 21 days, and then a placebo gum in the second treatment period (21 days). The other half will be assigned to follow the same schedule but with the treatment reversed. A statistician will perform the randomization. Primary outcomes are assessed by validated tools, such as the Plaque Index (PI), Gingival Index (GI), and percent of bleeding sites on probe (BOP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-blind, Crossover, Placebo-controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| CPC + Xylitol chewing gum, then Xylitol only chewing gum | Experimental | Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum, Drug: Xylitol only chewing gumCetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and then Xylitol only chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Xylitol only chewing gum will be used for the last 21 days. |
| Xylitol only chewing gum, then CPC + Xylitol chewing gum | Experimental | Drug: Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum, Drug: Xylitol only chewing gumXylitol only chewing gum and then Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. Xylitol only chewing gum will be used for the first 21 days, then there will be a washout period of 21 days, and finally Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum will be used for the last 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be aged 18 and older
- Be capable of giving informed consent themselves and are able and willing to participate in the study
- Patients willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
- Patients that regularly brush their teeth twice a day
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women
- Patients taking long-term anti-microbial or anti-inflammatory drugs
- Patients unable or unwilling to provide informed consent
- Self-reported use of tobacco products
- Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity
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 |
|---|---|---|
| Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gumAll subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. | Drug | CPC + Xylitol chewing gum, then Xylitol only chewing gum, Xylitol only chewing gum, then CPC + Xylitol chewing gum |
| Xylitol only chewing gumAll subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated. | Drug | CPC + Xylitol chewing gum, then Xylitol only chewing gum, Xylitol only chewing gum, then CPC + Xylitol chewing gum |
Primary outcome
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Time frame: day 1
Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 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 one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index
Time frame: day 22
Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index, where a score of 0 to 5 will be assigned to each facial and lingual non-restored surface of all teeth that are present with the exception of third molars at baseline and week 3 of the study, as follows. For each participant, an average of the scores for all teeth is calculated. 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 one mm but covering less than one-third of the crown of the tooth 4. Plaque covering at least one-third but less than two-thirds of the crown of the tooth 5. Plaque covering two-thirds or more of the crown of the tooth
Degree of Gingivitis as Assessed by the Gingival Index (GI)
Time frame: day 1
Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation. 1. Mild inflammation - slight change in color and little change in texture. 2. Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure. 3. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Degree of Gingivitis as Assessed by the Gingival Index (GI)
Time frame: day 22
Gingivitis will be assessed using the Gingival Index (GI), where a score of 0 to 3 will be assigned to six teeth, representing six segments of jaws, at baseline and week 3 of the study according to the following criteria. For each participant, an average of the scores for all 6 teeth is calculated. 0 Absence of inflammation. 1. Mild inflammation - slight change in color and little change in texture. 2. Moderate inflammation - moderate glazing, redness, edema, and hypertrophy. Bleeding on pressure. 3. Severe inflammation - marked redness and hypertrophy. Tendency to spontaneous bleeding. Ulceration.
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Time frame: day 1
Bleeding on probing (BOP) as described in Ainamo \& Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds 1. Bleeding after 30 seconds 2. Immediate bleeding
Degree of Gingival Bleeding as Assessed by the Bleeding on Probing (BOP) Index
Time frame: day 22
Bleeding on probing (BOP) as described in Ainamo \& Bay 1975 will be assessed, where each of 4 gingival areas (disto-buccal, midbuccal, mid-lingual, and mesio-lingual) around each tooth will be light probed and scored from 0 to 2 as follows. For each participant, an average of the scores for all teeth is calculated, an average of the scores for the 4 gingival areas is calculated. 0 Absence of bleeding after 30 seconds 1. Bleeding after 30 seconds 2. Immediate bleeding
2 secondary outcomes
Discoloration of Teeth as Assessed by the Vita Scale
Time frame: day 1
Discoloration of Teeth as Assessed by the Vita Scale
Time frame: day 22
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Active, not recruitingObservational study
Comparison of Saliva Characteristics and Oral Health in Pregnant and Non-pregnant Women
Plaque Induced Gingivitis
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.
Flavia Lakschevitz, DDS, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum and Xylitol only chewing gum in people with Gingivitis and Plaque, Dental, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 9 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 8 Feb 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?
Yes. Results are posted in the registry (first posted 8 Feb 2021). 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?
Degree of Plaque as Assessed by the Turesky Modification of the Quigley-Hein Plaque Index (time frame: day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.