Periodontal DiseasesNCT03364751
Effect of Switching From Cigarette Smoking to the Use of IQOS on Periodontitis Treatment Outcome
A study testing IQOS and Cigarette in people with Periodontal Diseases and Chronic Periodontitis, run by Philip Morris Products S.A. at 26 sites in Japan.
Trial summary
The purpose of this study was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the overall oral health status compared to continuing cigarette smoking. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Periodontal Diseases, Chronic Periodontitis, Periodontal Pocket
- What is being tested?
- IQOS and Cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 26 sitesJapan
- Study dates
- 7 Nov 2017to 12 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Patient is aged ≥ 30 years old.
- Patient has smoked on average at least 10 commercially available cigarettes per day for at least 5 years
- Patient has generalized chronic periodontitis (i.e., more than 30% of diseased teeth with a PD ≥ 4 mm).
Main Exclusion Criteria:
- Patient has self-reported history of diagnosed systemic diseases (e.g., stroke or acute cardiovascular event within the last 5 years, diabetes, active cancer).
- Patient received root planing therapy within the 6 months prior to Visit 1.
- Patient received surgical periodontal therapy within 3 years prior to Visit
- Patient was treated within the 3 months prior to Visit 1 with systemic antibiotics or was treated with topical antibiotics applied in the mouth.
- Continuous systemic use of steroidal or non-steroidal anti-inflammatory drugs for more than 20 days during the past 30-day period (except for low dose aspirin, i.e., ≤300 mg).
- Female patients who are pregnant, breast-feeding, or planning a pregnancy within the course of the study.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Japan26 sites
Sakai Dental Clinic
Bunkyō, Tokyo, 113-0033
Takano Dental Clinic
Chikusei, Ibaraki, 308- 0031
Kudan Dental Clinic
Chiyoda City, Tokyo, 102-0074
Yano Dental Clinic
Chōfu, Tokyo, 182-0024
Nikaido Dental Clinic
Chūō, Tokyo, 103-0027
Kimura Dental Clinic
Fukuoka, 810-0001
Yamashita Dental Office
Fukuoka, 810-0001
Yasumasu Dental Office
Fukuoka, 810-0001
Tsukiyama Dental Clinic
Fukuoka, 811-1302
Yoshida Shigeru Dental Office
Fukuoka, 812-0011
Mase Dental Clinic
Futtsu, Chiba, 293-0001
Kato Dental Clinic
Himi, Toyama, 935-0015
Yamashita Dental Clinic
Kagoshima, 890-0053
Heart Dental Clinic
Kagoshima, 892-0844
Yoshino Dental Clinic
Kawaguchi, Saitama, 332-0016
AOI Universal Hospital
Kawasaki, Kanagawa, 210-0822
Higashi Dental Office
Kumamoto, 860-0855
Matsunobu Dental Office
Miyako, Fukuoka, 800-0323
Tsudanuma Olive Dental Clinic
Narashino, Chiba, 275-0016
Taniguchi Dental Clinic
Sapporo, Hokkaido, 003-0023
Mune Dental Clinic
Setagaya City, Tokyo, 157-0072
Kikuchi Dental Clinic
Shinjuku, Tokyo, 160-0023
Saida Dental Clinic
Tokorozawa, Saitama, 359-1146
Miyata Dental Clinic
Toshima City, Tokyo, 171-0043
Tsukuba Healthcare Dental Clinic
Tsukuba, Ibaraki, 305-0834
Yoshinaga Dental Office
Uki, Kumamoto, 869-0521
About this study
Official title: A 6-month Randomized, Controlled, Open-label, 2-arm Parallel Group, Multicenter Study to Evaluate the Effect of Switching From Cigarette Smoking to the Use of IQOS in Smokers With Generalized Chronic Periodontitis on the Response to Mechanical Periodontal Treatment and Oral Health Status.
The purpose of this study was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the overall oral health status compared to continuing cigarette smoking.
Note: "IQOS" is the Tobacco Heating System (THS) with Marlboro Heatsticks, marketed in Japan under the brand name IQOS
Read the detailed description
This was a randomized, controlled, open-label, 2-arm, parallel group ambulatory study with the randomization stratified by daily cigarette consumption over the month (30 days) prior to Visit 1 (10-19 cigarettes/day vs. > 19 cigarettes/day) and disease severity recorded at Visit 1 (< 5 mm Pocket Depth [PD] vs. ≥ 5 mm PD) based on the most severely diseased tooth, in smokers with generalized chronic periodontitis who are randomized to either switch from cigarette smoking to IQOS use or continuing cigarette smoking.
- Conditions
- Periodontal Diseases, Chronic Periodontitis, Periodontal Pocket, Tooth Mobility, Gingival Diseases, Smoking, Cigarette
- Being tested
- IQOS, Cigarette
- Keywords
- Oral Health, Smoking, Cigarette, Reduced risk product, Tobacco heating system, THS, Modified risk tobacco product, Clinical attachment level
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis, Periodontal Pocket, Tooth Mobility, Gingival Diseases, Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IQOSOther
Patients will switch from cigarette smoking to ad libitum IQOS use.
CigaretteOther
Patients will continue to smoke cigarettes ad libitum.
| Study group | Role | What they receive |
|---|---|---|
| IQOS arm | Active comparator | ~86 patients, switching from cigarette smoking to IQOS use. Receives: Other: IQOS |
| Cigarette arm | Active comparator | ~86 patients, continuing cigarette smoking. Receives: Other: Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Measured: At 6 months
Secondary outcomes (17)
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Measured: At 3 months
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Measured: At 3 months and 6 months
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Measured: From baseline to 3 months and 6 months
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change from baseline will be measured in sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Measured: From baseline to 3 months and 6 months
Full-mouth Periodontal PD Change Over Time.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Change in mean full-mouth PD will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Measured: From baseline to 3 months and 6 months
Full-mouth Clinical Attachment Level (CAL) Over Time.
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Change in mean full-mouth CAL will be measured, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
Measured: From baseline to 3 months and 6 months
Peridontal PD Reduction.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean PD change will be measured in sites with initial PD < 4 mm, and with initial PD of 4 mm to <5 mm, 5 mm to < 6 mm, 6 mm to < 7 mm and ≥ 7 mm.
Measured: From baseline to 3 months and 6 months
Clinical Attachment Level Improvement
Clinical attachment level (CAL) is the measured distance from cementoenamel junction (CEJ) to the bottom of pocket using a periodontal probe. Mean CAL change will be measured in sites with initial PD < 4 mm, and with initial PD of 4 mm to <5 mm, 5 mm to < 6 mm, 6 mm to < 7 mm and ≥ 7 mm.
Measured: From baseline to 3 months and 6 months
Number of Periodontally Diseased Sites.
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Any change will be recorded in the number of periodontally diseased sites with Pocket Depth (PD) < 4 mm, with PD 4 mm to < 5mm, with PD 5 mm to < 6 mm , with PD 6 mm to < 7 mm and with PD ≥ 7 mm. PD is the distance from the gingival margin to which a probe penetrates into the pocket.
Measured: From baseline to 3 months and 6 months
Gingival Inflammation
Gingival inflammation will be measured by calculating the gingival index (GI) score for each target tooth.
The gingival index (GI) scores each site on a 0 to 3 scale, with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding.
Measured: From baseline to 3 months and 6 months
Tooth Mobility
Tooth mobility will be graded according to Miller's mobility index (MMI), which is the most widely accepted method for routine clinical examinations of tooth mobility. The tooth is held between the metallic handles of two instruments and moved in the buccolingual or buccopalatal direction, and the moved distance is visually estimated by the person conducting the examination.
Grade 0: Physiologic movement within 0.2 mm; Grade 1: Slight mobility, tooth can be moved 0.2 - 1 mm labiolingually; Grade 2: Moderate mobility, tooth can be moved 1 - 2 mm labiolingually or mesiodistally; Grade 3: Severe mobility, tooth can be moved more than 2 mm labiolingually or mesiodistally, or ability to depress the tooth in a vertical direction.
Measured: From baseline to 3 months and 6 months
Presence of Plaque on Tooth Surfaces in Full Mouth
Plaque will be measured using the plaque control record (PCR) percentage.
Measured: From baseline to 3 months and 6 months
Inflammatory Status in Periodontal Pockets
Gum inflammation was measured using percentage of teeth bleeding on probing (BOP).
BOP in full mouth was measured to assess inflammatory status in the pocket and was assessed as YES or NO of bleeding at 6 sites per tooth. Gently probing (approximately 20 g pressure), the bleeding site within 30 seconds was assessed as YES.
Measured: From baseline to 3 months and 6 months
Concentrations of Urinary Nicotine Equivalents (NEQ)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (mg/g creat).
Measured: From baseline to 3 months and 6 months
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (pg/mg creat).
Measured: From baseline to 3 months and 6 months
Concentrations of 2-cyanoethylmercapturic Acid (CEMA)
This biomarker of exposure to a tobacco smoke constituent will be measured in patients who switch to IQOS use and patients who continue cigarette smoking. Concentrations measured in urine and expressed as concentration adjusted for creatinine (ng/mg creat).
Measured: From baseline to 3 months and 6 months
Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.
Self-reported use of tobacco or nicotine containing products will be measured over the study in patients switching to IQOS use and patients who continue cigarette smoking.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start7 Nov 2017
- Primary completion21 Dec 2018
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christelle Haziza, PhD, Study chair, Philip Morris Products S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364751
- Sponsor's protocol ID
- P1-OHS-01-JP
- Status last verified
- Jan 2023
- First submitted
- 23 Nov 2017
- Last updated
- 30 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pouly S, Ng WT, Benzimra M, Soulan A, Blanc N, Zanetti F, Picavet P, Baker G, Haziza C. Effect of Switching to the Tobacco Heating System Versus Continued Cigarette Smoking on Chronic Generalized Periodontitis Treatment Outcome: Protocol for a Randomized Controlled Multicenter Study. JMIR Res Protoc. 2021 Jan 18;10(1):e15350. doi: 10.2196/15350.
PubMed 33459599Effect of switching from cigarette smoking to the use of the tobacco heating system on periodontitis treatment outcome: Periodontal parameter results from a multicenter Japanese study Authors: Pouly, Sandrine; Ng, Wee Teck; Blanc, Nicolas; Hession, Paul; Zanetti, Filippo; Battey, James N. D.; de La Bourdonnaye, Guillaume; Heremans, Annie; Haziza, Christelle Journal Title: Frontiers in dental medicine Publication Date: 7/22/2022 Volume: 3 DOI: 10.3389/fdmed.2022.915079
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month Randomized, Controlled, Open-label, 2-arm Parallel Group, Multicenter Study to Evaluate the Effect of Switching From Cigarette Smoking to the Use of IQOS in Smokers With Generalized Chronic Periodontitis on the Response to Mechanical Periodontal Treatment and Oral Health Status.
- ClinicalTrials.gov ID
- NCT03364751
- Acronym / sponsor ID
- P1-OHS-01-JP
- Conditions
- Periodontal Diseases, Chronic Periodontitis, Periodontal Pocket, Tooth Mobility, Gingival Diseases, Smoking, Cigarette
- Keywords
- Oral Health, Smoking, Cigarette, Reduced risk product, Tobacco heating system, THS, Modified risk tobacco product, Clinical attachment level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Posted 18 Feb 2021
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 was to demonstrate in patients with generalized chronic periodontitis that switching from cigarette smoking to using IQOS improves the response to periodontal therapy and the overall oral health status compared to continuing cigarette smoking.
Note: "IQOS" is the Tobacco Heating System (THS) with Marlboro Heatsticks, marketed in Japan under the brand name IQOS
Detailed description
This was a randomized, controlled, open-label, 2-arm, parallel group ambulatory study with the randomization stratified by daily cigarette consumption over the month (30 days) prior to Visit 1 (10-19 cigarettes/day vs. > 19 cigarettes/day) and disease severity recorded at Visit 1 (< 5 mm Pocket Depth [PD] vs. ≥ 5 mm PD) based on the most severely diseased tooth, in smokers with generalized chronic periodontitis who are randomized to either switch from cigarette smoking to IQOS use or continuing cigarette smoking.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IQOS arm | Active comparator | Other: IQOS~86 patients, switching from cigarette smoking to IQOS use. |
| Cigarette arm | Active comparator | Other: Cigarette~86 patients, continuing cigarette smoking. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| IQOSPatients will switch from cigarette smoking to ad libitum IQOS use. | Other | IQOS arm |
| CigarettePatients will continue to smoke cigarettes ad libitum. | Other | Cigarette arm |
Primary outcome
Periodontal Pocket Depth (PD) Change From Baseline at 6 Months
Time frame: At 6 months
Pocket depth (PD) is the distance from the gingival margin to which a probe penetrates into the pocket. Mean Periodontal PD change from baseline will be measured in all sites with initial PD ≥ 4 mm, following mechanical periodontal therapy, in patients who switch to IQOS use compared to those who continue cigarette smoking.
17 secondary outcomes
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm)
Time frame: At 3 months
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm)
Time frame: At 3 months and 6 months
Periodontal Pocket Depth (PD) Change Over Time. (Mean PD in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Time frame: From baseline to 3 months and 6 months
Clinical Attachment Level (CAL) Change Over Time (Mean CAL in All Subjects With Initial PD ≥ 4 mm) - Descriptive Statistics
Time frame: From baseline to 3 months and 6 months
Full-mouth Periodontal PD Change Over Time.
Time frame: From baseline to 3 months and 6 months
Full-mouth Clinical Attachment Level (CAL) Over Time.
Time frame: From baseline to 3 months and 6 months
Peridontal PD Reduction.
Time frame: From baseline to 3 months and 6 months
Clinical Attachment Level Improvement
Time frame: From baseline to 3 months and 6 months
Number of Periodontally Diseased Sites.
Time frame: From baseline to 3 months and 6 months
Gingival Inflammation
Time frame: From baseline to 3 months and 6 months
Tooth Mobility
Time frame: From baseline to 3 months and 6 months
Presence of Plaque on Tooth Surfaces in Full Mouth
Time frame: From baseline to 3 months and 6 months
Inflammatory Status in Periodontal Pockets
Time frame: From baseline to 3 months and 6 months
Concentrations of Urinary Nicotine Equivalents (NEQ)
Time frame: From baseline to 3 months and 6 months
Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
Time frame: From baseline to 3 months and 6 months
Concentrations of 2-cyanoethylmercapturic Acid (CEMA)
Time frame: From baseline to 3 months and 6 months
Use of Tobacco or Nicotine-containing Products in Patients Switching to IQOS Use and Patients Who Continue Cigarette Smoking.
Time frame: From baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33459599Pouly S, Ng WT, Benzimra M, Soulan A, Blanc N, Zanetti F, Picavet P, Baker G, Haziza C. Effect of Switching to the Tobacco Heating System Versus Continued Cigarette Smoking on Chronic Generalized Periodontitis Treatment Outcome: Protocol for a Randomized Controlled Multicenter Study. JMIR Res Protoc. 2021 Jan 18;10(1):e15350. doi: 10.2196/15350.
- Results publicationEffect of switching from cigarette smoking to the use of the tobacco heating system on periodontitis treatment outcome: Periodontal parameter results from a multicenter Japanese study Authors: Pouly, Sandrine; Ng, Wee Teck; Blanc, Nicolas; Hession, Paul; Zanetti, Filippo; Battey, James N. D.; de La Bourdonnaye, Guillaume; Heremans, Annie; Haziza, Christelle Journal Title: Frontiers in dental medicine Publication Date: 7/22/2022 Volume: 3 DOI: 10.3389/fdmed.2022.915079
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Haziza, PhD study chair
Philip Morris Products S.A.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IQOS and Cigarette in people with Periodontal Diseases and Chronic Periodontitis, run by Philip Morris Products S.A. at 26 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Japan. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 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?
Periodontal Pocket Depth (PD) Change From Baseline at 6 Months (time frame: At 6 months). 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 NCT03364751, 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 30 Jan 2023.