Orthodontic Appliance ComplicationNCT05191069
Effect of Moringa Oleifera Mouthwash
A study testing Moringa Oleifera Mouthwash in people with Orthodontic Appliance Complication, run by Riphah International University at 1 site in Pakistan.
Trial summary
Improvement of oral hygiene maintenance is very important during fixed orthodontic appliance treatment to prevent the degenerative effects. Different mouthwashes are available in market but this study is being conducted to check the effects of Moring Oleifera mouth wash against the development of Gingivitis… Read more about this study
- Who is it for?
- Ages 13 to 30 years
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Moringa Oleifera Mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Dec 2021to 30 Oct 2022
- Phase
- Interventional
- 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 13 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Young healthy subjects undergoing orthodontic treatment.
- Patients with all permanent teeth present without any oral pathology.
- Healthy gingiva with no bleeding on probing before start of orthodontic treatment and a normal pocket depth (1-3mm) on all teeth.
- No WSLs (score = 1
Who cannot join
- History of smoking, patients suffering from any systemic illness like diabetes.
- Gingivitis or an active periodontal disease.
- Carious lesions on labial/buccal surface of teeth.
- Mentally handicapped individuals
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Islamic International Dental Hospital
Islamabad, Islamabad, 44000
About this study
Official title: Effects of Moringa Oleifera Mouthwash in Patients Undergoing Fixed Orthodontic Appliance Treatment: a Parallel Arm, Triple Blinded, Randomized Controlled Trial
Improvement of oral hygiene maintenance is very important during fixed orthodontic appliance treatment to prevent the degenerative effects. Different mouthwashes are available in market but this study is being conducted to check the effects of Moring Oleifera mouth wash against the development of Gingivitis, Periodontitis, Plaque formation, Enamel Demineralization /white spot lesion, discoloration and bacterial load in dental plaque during the fixed orthodontic treatment.
Read the detailed description
With the increase in desire of improved facial and dental aesthetics among all social classes, the numbers of cases being treated with fixed orthodontic appliances are increasing. It is difficult to maintain certain standard of oral hygiene with the braces on, so the iatrogenic degenerative effects of fixed orthodontic appliances are somewhat inevitable. Along with proper brushing and flossing orthodontists advise the use of mouthwash as well in order to prevent or lessen the severity of gingivitis, periodontitis, gingival hyperplasia, demineralization, white spot lesions, discoloration of teeth etc.
Plenty of mouth washes are available in market containing varying concentration of different chemicals promising to improve the oral health and reduce inflammation. But all of them having certain side effects most common being the discoloration. The focus is being shifted to natural ingredients to gain the same or even better results with minimum to zero side effects. In quest of getting closer to Mother Nature Moringa Oleifera leaf was discovered in 1785 in Indian Subcontinent.
Moringa Oleifera is a nutraceutical and well known for its anti-inflammatory, anti-microbial, anti-cancer, anti-diabetes, anti-rheumatoid arthritis, hepatoprotective, Steroid-genesis modulators and neuroprotective functions and many other properties. Its leaves evidently contain various natural anti-inflammatory and anti-oxidant substances namely flavonoid, phenolic and carotenoid. Besides, MO leaves also rich in protein, vitamin C, vitamin A, calcium and potassium. Flavonoids may act as antioxidant by scavenging free radical and protecting the cell from oxidative stress. Recently quite a lot work has been done on flavonoids in dentistry which includes anti-bacterial/anti-cariogenic effects, reduction in plague formation, Treatment in surgical wounds, reduction in dentinal hypersensitivity, treatment of periodontitis and gingivitis because of its anti-inflammatory and anti-oxidative effects.
Previously studies have been done to check the efficacy of different herbal mouthwashes but no study has been done to check the efficacy of MO leaf extract mouth wash on the oral health of the patients having fixed orthodontic treatment
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Moringa Oleifera Mouthwash, Placebo Mouthwash
- Keywords
- Moringa Oleifera, Moringa Mouthwash, Fixed Orthodontic Treatmnet, Moringa Mouthwash in orthodontics, Orthodontics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa Oleifera MouthwashOther
15ml of the mouthwash to be used twice daily for 6 months
Placebo MouthwashOther
15ml of the mouthwash to be used twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Moringa Oleifera Mouthwash | Experimental | 15ml of Moringa Oleifera mouthwash will be given to be used twice daily for 6 months. Receives: Other: Moringa Oleifera Mouthwash |
| Placebo Mouthwash | Placebo comparator | The mouthwash will have all other ingredients other than Moringa Oleifera extract. Participants will be advised to use 15ml of Placebo mouthwash twice daily for 6 months. Receives: Other: Placebo Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Probing Depth
Changes from baseline, the probing depth scale will be used to assess the pocket depth, and is graded from 0-5, 0= no No pockets>3.5mm, no calculus/overhangs, no bleeding after probing(black band completely visible). 1=No pockets>3.5mm, no calculus/overhangs, but bleeding after probing(black band completely visible). 2= No pockets>3.5mm, but supra or subgingival calculus/overhangs(black band completely visible). 3=Probing depth 3.5-5.5mm (black band partially visible, indicating pocket of 4-5mm). 4=Probing depth> 5.5mm (black band entirely within pocket, indicating pocket of 6mm or more). 5=Furcation involvement.
Measured: 7 months
Plaque Index
Changes from base line, quantity of plaque will be assessed using plaque index, graded from 0-4, 0=Absence of microbial plaque. 1=Thin film of microbial plaque along the free gingival margin. 2=Moderate accumulation with plaque in the sulcus. 3=Large amount of plaque in sulcus or pocket along the free gingival margin.
Measured: 7 months
White spot Lesions
Changes from the baseline, white spot lesions will be assessed visually by grading from 1-4. 1= Normal, 2= Slight, 3= Severe, 4= Cavitation.
Measured: 7 months
Modified Gingival Index
Changes from the baseline, gingivitis will be assessed using this index graded from0-4, 0= Normal, 1=Mild inflammation, slight change in color, little change in texture of any portion of gingival unit. 2= Mild inflammation of entire gingival unit. 3=Moderate inflammation of entire gingival unit. 4=Severe inflammation of entire gingival unit.
Measured: 7 months
Discoloration of teeth
Changes from the baseline, discoloration will be assessed by taking photographs on every interval using the same camera at the same settings. these photographs will be assessed from by 2 panels 2 weeks apart.
Measured: 7 months
Bacterial Load In Plaque
Changes from the baseline, Colony forming units will be measured by doing microbial analysis. Quantity of CFUs for S. mutans and P. Gingivalis will be used.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start23 Dec 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulfat Bashir, Masters, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191069
- Sponsor's protocol ID
- MINS/69/2020 Rabia Afreen
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Anezi SA, Harradine NW. Quantifying plaque during orthodontic treatment: Angle Orthod. 2012 Jul;82(4):748-53. doi: 10.2319/050111-312.1. Epub 2011 Nov 1.
PubMed 22044115Atanasova S, Kovachevska I, Nashkova S, Toneva V, Zlatanovska K, Longurova N. Side effects of orthodontic treatment. Knowledge International Journal. 2018;23(2):665-71
Sioustis I, Martu M-A, Luchian I, Teodorescu C, Kappenberg-Nitescu D-C, Iovan A, et al. Clinical effects of orthodontic treatment on periodontal status. Review. Rom J of Medical and Dental Education. 2019;8(3):57-6
Haas AN, Pannuti CM, Andrade AK, Escobar EC, Almeida ER, Costa FO, Cortelli JR, Cortelli SC, Rode SD, Pedrazzi V, Oppermann RV. Mouthwashes for the control of supragingival biofilm and gingivitis in orthodontic patients: evidence-based recommendations for clinicians. Braz Oral Res. 2014 Jul 11;28(spe):1-8. doi: 10.1590/1807-3107bor-2014.vol28.0021. Epub 2014 Jul 11.
PubMed 25055220Jeyakumar J, Sculean A, Eick S. Anti-biofilm Activity of Oral Health-care Products Containing Chlorhexidine Digluconate and Citrox. Oral Health Prev Dent. 2020 Oct 27;18(4):981-990. doi: 10.3290/j.ohpd.a45437.
PubMed 33215489Van Strydonck DA, Slot DE, Van der Velden U, Van der Weijden F. Effect of a chlorhexidine mouthrinse on plaque, gingival inflammation and staining in gingivitis patients: a systematic review. J Clin Periodontol. 2012 Nov;39(11):1042-55. doi: 10.1111/j.1600-051X.2012.01883.x. Epub 2012 Sep 7.
PubMed 22957711Dubey DK, Dora J, Kumar A, Gulsan RK. A multipurpose tree-Moringa oleifera. International Journal of Pharmaceutical and Chemical Sciences. 2013;2(1):415-23
Sankari SL, Babu NA, Rani V, Priyadharsini C, Masthan KM. Flavonoids - Clinical effects and applications in dentistry: A review. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S26-9. doi: 10.4103/0975-7406.137256.
PubMed 25210379Panche AN, Diwan AD, Chandra SR. Flavonoids: an overview. J Nutr Sci. 2016 Dec 29;5:e47. doi: 10.1017/jns.2016.41. eCollection 2016.
PubMed 28620474Buakaew W, Sranujit RP, Noysang C, Sangouam S, Suphrom N, Thongsri Y, Potup P, Usuwanthim K. Evaluation of Mouthwash Containing Citrus hystrix DC., Moringa oleifera Lam. and Azadirachta indica A. Juss. Leaf Extracts on Dental Plaque and Gingivitis. Plants (Basel). 2021 Jun 6;10(6):1153. doi: 10.3390/plants10061153.
PubMed 34204096Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
PubMed 5237684
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moringa Oleifera Mouthwash in Patients Undergoing Fixed Orthodontic Appliance Treatment: a Parallel Arm, Triple Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05191069
- Acronym / sponsor ID
- MINS/69/2020 Rabia Afreen
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Moringa Oleifera, Moringa Mouthwash, Fixed Orthodontic Treatmnet, Moringa Mouthwash in orthodontics, Orthodontics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 13 Jan 2022 (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.
Improvement of oral hygiene maintenance is very important during fixed orthodontic appliance treatment to prevent the degenerative effects. Different mouthwashes are available in market but this study is being conducted to check the effects of Moring Oleifera mouth wash against the development of Gingivitis, Periodontitis, Plaque formation, Enamel Demineralization /white spot lesion, discoloration and bacterial load in dental plaque during the fixed orthodontic treatment.
Detailed description
With the increase in desire of improved facial and dental aesthetics among all social classes, the numbers of cases being treated with fixed orthodontic appliances are increasing. It is difficult to maintain certain standard of oral hygiene with the braces on, so the iatrogenic degenerative effects of fixed orthodontic appliances are somewhat inevitable. Along with proper brushing and flossing orthodontists advise the use of mouthwash as well in order to prevent or lessen the severity of gingivitis, periodontitis, gingival hyperplasia, demineralization, white spot lesions, discoloration of teeth etc.
Plenty of mouth washes are available in market containing varying concentration of different chemicals promising to improve the oral health and reduce inflammation. But all of them having certain side effects most common being the discoloration. The focus is being shifted to natural ingredients to gain the same or even better results with minimum to zero side effects. In quest of getting closer to Mother Nature Moringa Oleifera leaf was discovered in 1785 in Indian Subcontinent.
Moringa Oleifera is a nutraceutical and well known for its anti-inflammatory, anti-microbial, anti-cancer, anti-diabetes, anti-rheumatoid arthritis, hepatoprotective, Steroid-genesis modulators and neuroprotective functions and many other properties. Its leaves evidently contain various natural anti-inflammatory and anti-oxidant substances namely flavonoid, phenolic and carotenoid. Besides, MO leaves also rich in protein, vitamin C, vitamin A, calcium and potassium. Flavonoids may act as antioxidant by scavenging free radical and protecting the cell from oxidative stress. Recently quite a lot work has been done on flavonoids in dentistry which includes anti-bacterial/anti-cariogenic effects, reduction in plague formation, Treatment in surgical wounds, reduction in dentinal hypersensitivity, treatment of periodontitis and gingivitis because of its anti-inflammatory and anti-oxidative effects.
Previously studies have been done to check the efficacy of different herbal mouthwashes but no study has been done to check the efficacy of MO leaf extract mouth wash on the oral health of the patients having fixed orthodontic treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moringa Oleifera Mouthwash | Experimental | Other: Moringa Oleifera Mouthwash15ml of Moringa Oleifera mouthwash will be given to be used twice daily for 6 months. |
| Placebo Mouthwash | Placebo comparator | Other: Placebo MouthwashThe mouthwash will have all other ingredients other than Moringa Oleifera extract. Participants will be advised to use 15ml of Placebo mouthwash twice daily for 6 months. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Young healthy subjects undergoing orthodontic treatment.
- Patients with all permanent teeth present without any oral pathology.
- Healthy gingiva with no bleeding on probing before start of orthodontic treatment and a normal pocket depth (1-3mm) on all teeth.
- No WSLs (score = 1
Key exclusion criteria (4 listed)
- History of smoking, patients suffering from any systemic illness like diabetes.
- Gingivitis or an active periodontal disease.
- Carious lesions on labial/buccal surface of teeth.
- Mentally handicapped individuals
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 |
|---|---|---|
| Moringa Oleifera Mouthwash15ml of the mouthwash to be used twice daily for 6 months | Other | Moringa Oleifera Mouthwash |
| Placebo Mouthwash15ml of the mouthwash to be used twice daily for 6 months | Other | Placebo Mouthwash |
Primary outcome
Periodontal Probing Depth
Time frame: 7 months
Changes from baseline, the probing depth scale will be used to assess the pocket depth, and is graded from 0-5, 0= no No pockets>3.5mm, no calculus/overhangs, no bleeding after probing(black band completely visible). 1=No pockets>3.5mm, no calculus/overhangs, but bleeding after probing(black band completely visible). 2= No pockets>3.5mm, but supra or subgingival calculus/overhangs(black band completely visible). 3=Probing depth 3.5-5.5mm (black band partially visible, indicating pocket of 4-5mm). 4=Probing depth> 5.5mm (black band entirely within pocket, indicating pocket of 6mm or more). 5=Furcation involvement.
Plaque Index
Time frame: 7 months
Changes from base line, quantity of plaque will be assessed using plaque index, graded from 0-4, 0=Absence of microbial plaque. 1=Thin film of microbial plaque along the free gingival margin. 2=Moderate accumulation with plaque in the sulcus. 3=Large amount of plaque in sulcus or pocket along the free gingival margin.
White spot Lesions
Time frame: 7 months
Changes from the baseline, white spot lesions will be assessed visually by grading from 1-4. 1= Normal, 2= Slight, 3= Severe, 4= Cavitation.
Modified Gingival Index
Time frame: 7 months
Changes from the baseline, gingivitis will be assessed using this index graded from0-4, 0= Normal, 1=Mild inflammation, slight change in color, little change in texture of any portion of gingival unit. 2= Mild inflammation of entire gingival unit. 3=Moderate inflammation of entire gingival unit. 4=Severe inflammation of entire gingival unit.
Discoloration of teeth
Time frame: 7 months
Changes from the baseline, discoloration will be assessed by taking photographs on every interval using the same camera at the same settings. these photographs will be assessed from by 2 panels 2 weeks apart.
Bacterial Load In Plaque
Time frame: 3 months
Changes from the baseline, Colony forming units will be measured by doing microbial analysis. Quantity of CFUs for S. mutans and P. Gingivalis will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Background: PubMed 22044115Al-Anezi SA, Harradine NW. Quantifying plaque during orthodontic treatment: Angle Orthod. 2012 Jul;82(4):748-53. doi: 10.2319/050111-312.1. Epub 2011 Nov 1.
- BackgroundAtanasova S, Kovachevska I, Nashkova S, Toneva V, Zlatanovska K, Longurova N. Side effects of orthodontic treatment. Knowledge International Journal. 2018;23(2):665-71
- BackgroundSioustis I, Martu M-A, Luchian I, Teodorescu C, Kappenberg-Nitescu D-C, Iovan A, et al. Clinical effects of orthodontic treatment on periodontal status. Review. Rom J of Medical and Dental Education. 2019;8(3):57-6
- Background: PubMed 25055220Haas AN, Pannuti CM, Andrade AK, Escobar EC, Almeida ER, Costa FO, Cortelli JR, Cortelli SC, Rode SD, Pedrazzi V, Oppermann RV. Mouthwashes for the control of supragingival biofilm and gingivitis in orthodontic patients: evidence-based recommendations for clinicians. Braz Oral Res. 2014 Jul 11;28(spe):1-8. doi: 10.1590/1807-3107bor-2014.vol28.0021. Epub 2014 Jul 11.
- Background: PubMed 33215489Jeyakumar J, Sculean A, Eick S. Anti-biofilm Activity of Oral Health-care Products Containing Chlorhexidine Digluconate and Citrox. Oral Health Prev Dent. 2020 Oct 27;18(4):981-990. doi: 10.3290/j.ohpd.a45437.
- Background: PubMed 22957711Van Strydonck DA, Slot DE, Van der Velden U, Van der Weijden F. Effect of a chlorhexidine mouthrinse on plaque, gingival inflammation and staining in gingivitis patients: a systematic review. J Clin Periodontol. 2012 Nov;39(11):1042-55. doi: 10.1111/j.1600-051X.2012.01883.x. Epub 2012 Sep 7.
- BackgroundDubey DK, Dora J, Kumar A, Gulsan RK. A multipurpose tree-Moringa oleifera. International Journal of Pharmaceutical and Chemical Sciences. 2013;2(1):415-23
- Background: PubMed 25210379Sankari SL, Babu NA, Rani V, Priyadharsini C, Masthan KM. Flavonoids - Clinical effects and applications in dentistry: A review. J Pharm Bioallied Sci. 2014 Jul;6(Suppl 1):S26-9. doi: 10.4103/0975-7406.137256.
- Background: PubMed 28620474Panche AN, Diwan AD, Chandra SR. Flavonoids: an overview. J Nutr Sci. 2016 Dec 29;5:e47. doi: 10.1017/jns.2016.41. eCollection 2016.
- Background: PubMed 34204096Buakaew W, Sranujit RP, Noysang C, Sangouam S, Suphrom N, Thongsri Y, Potup P, Usuwanthim K. Evaluation of Mouthwash Containing Citrus hystrix DC., Moringa oleifera Lam. and Azadirachta indica A. Juss. Leaf Extracts on Dental Plaque and Gingivitis. Plants (Basel). 2021 Jun 6;10(6):1153. doi: 10.3390/plants10061153.
- Background: PubMed 5237684Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- 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.
Ulfat Bashir, Masters principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa Oleifera Mouthwash in people with Orthodontic Appliance Complication, run by Riphah International University at 1 site in Pakistan.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2022. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 Probing Depth (time frame: 7 months). 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?
On the ClinicalTrials.gov record for NCT05191069, which also lists 11 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 13 Jan 2022; AzTrials last refreshed its copy on 1 Nov 2026.