Malocclusion, Angle Class IIPONCOSNCT03455634
Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
A study testing Twin Block and Sander bite jumping appliance in people with Malocclusion, Angle Class II, run by Visnja Katic at 1 site in Croatia.
Trial summary
Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic treatment, drop-out from orthodontic treatment and success of orthodontic treatment. Methods: evaluation before, during and at the end of orthodontic treatment. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Twin Block and Sander bite jumping appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCroatia
- Study dates
- 9 Feb 2015to 17 May 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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- distal molar occlusion, overjet >5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4
Who cannot join
- mental retardation
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University of Rijeka, Faculty of Dental Medicine
Rijeka, Primorsko-goranska County, HR-51000
About this study
Official title: Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome
Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic treatment, drop-out from orthodontic treatment and success of orthodontic treatment.
Methods: evaluation before, during and at the end of orthodontic treatment. Clinical and diagnostic evaluation of complexity before and at the end of orthodontic treatment, evaluation of awareness of treatment need, impact on social and psychological aspects, functional disturbances, impact of malocclusion on quality of life, social interaction, ability to perform daily activities.
Read the detailed description
Data will include diagnostic measurements on study casts, x-rays, and data from questionnaires given to children and parents. Statistical analyses will explore predictors of treatment success with treatment need, compliance and psycho-social domains.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Twin Block, Sander bite jumping appliance
- Keywords
- quality of life
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twin BlockDevice
functional appliances for the stimulation of the mandibular growth
Sander bite jumping applianceDevice
functional appliances for the stimulation of the mandibular growth
| Study group | Role | What they receive |
|---|---|---|
| Twin Block | Active comparator | Twin Block functional appliance Receives: Device: Twin Block |
| Sander | Active comparator | Sander bite jumping appliance Receives: Device: Sander bite jumping appliance |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overjet
sagittal distance between upper and lower anterior teeth measured in mm
Measured: baseline
Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of oral symptoms on quality of life
Measured: baseline
subscale functional limitations of CPQ 11-14 SF16
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of functional limitations on quality of life
Measured: baseline
subscale emotional well-being of CPQ 11-14 SF16
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of emotional wee-being on quality of life
Measured: baseline
subscale social well-being of CPQ 11-14 SF 16
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of social well-being on quality of life
Measured: baseline
Self-perceived satisfaction with dental appearance
rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance
Measured: baseline
Self-perceived treatment need
rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need
Measured: baseline
overall score of CPQ 11-14 SF 16 and SF8
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-32 for SF8 and 0-64 for SF16 (sum of all items in short-form 8 and 16 instruments), higher score means higher impact of oral disorders on quality of life
Measured: baseline
change in overjet
sagittal distance between upper and lower anterior teeth measured in mm
Measured: change from baseline to one year of appliance wear
Secondary outcomes (18)
Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms
P CPQ, answers on 5-point Likert scale (0-4), score range 0-24, higher score means greater impact of children's oral health status on oral symptoms, as perceived by parents / caregivers
Measured: baseline
P CPQ, subscale functional limitations
P CPQ, answers on 5-point Likert scale (0-4), score range 0-28, higher score means greater impact of children's oral health status on functional limitations, as perceived by parents / caregivers
Measured: baseline
P CPQ, subscale emotional well-being
P CPQ, answers on 5-point Likert scale (0-4), score range 0-32, higher score means greater impact of children's oral health status on emotional well-being, as perceived by parents / caregivers
Measured: baseline
P CPQ, subscale social well-being
P CPQ, answers on 5-point Likert scale (0-4), score range 0-40, higher score means greater impact of children's oral health status on social well-being, as perceived by parents / caregivers
Measured: baseline
overall score of P CPQ
P CPQ, answers on 5-point Likert scale (0-4), score range 0-124 (sum of subscales), higher score means greater impact of children's oral health status on quality of life, as perceived by parents / caregivers
Measured: baseline
parental/family activity subscale of Family Impact Scale (FIS) questionnaire
FIS questionnaire, answers on 5-point Likert scale (0-4), score range 0-20, higher score means greater impact of children's oral health status on parental/family activity, as perceived by parents / caregivers
Measured: baseline
parental emotions subscale of FIS
FIS, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of children's oral health status on parental emotions, as perceived by parents / caregivers
Measured: baseline
family conflict subscale of FIS
FIS, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of children's oral health status on family conflict, as perceived by parents / caregivers
Measured: baseline
financial burden subscale of FIS
FIS, answers on 5-point Likert scale (0-4), score range 0-4, higher score means greater impact of children's oral health status on financial burden, as perceived by parents / caregivers
Measured: baseline
overall score of FIS
FIS, answers on 5-point Likert scale (0-4), score range 0-56 (sum of subscales), higher score means greater impact of children's oral health status on family, as perceived by parents / caregivers
Measured: baseline
change in oral symptoms of CPQ 11-14 SF16
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change of oral symptoms on quality of life
Measured: change from baseline to one year of appliance wear
change in functional limitations of CPQ
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change in functional limitations on quality of life
Measured: change from baseline to one year of appliance wear
change in emotional well-being of CPQ
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change in emotional well-being on quality of life
Measured: change from baseline to one year of appliance wear
change in social well-being of CPQ
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, change in sum score from baseline to one year of appliance, higher score means greater impact of change in social well-being on quality of life
Measured: change from baseline to one year of appliance wear
change in overall score of CPQ SF8
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-32, change in sum score from baseline to one year of appliance, higher score means greater impact of change in oral disorders on quality of life
Measured: change from baseline to one year of appliance wear
validation of CPQ 11-14 in Croatia
16 items and 8 items short form questionnaires, answers on 5-point Likert scale (0-4), score range 0-64, higher score means greater impairment of quality of life
Measured: one year
validation of P CPQ in Croatia
31 items, answers on 5-point Likert scale (0-4), score range 0-124, higher score means greater impairment of childrens' quality of life perceived by their parents
Measured: one year
validation of FIS in Croatia
14 items, answers on 5-point Likert scale (0-4), score range 0-56, higher score means greater impairment of children's' quality of life perceived by their parents
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start9 Feb 2015
- Primary completion1 Apr 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IIStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visnja Katic
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Center Rijeka, University of Rijeka
- Responsible party
- Sponsor-investigator, Visnja Katic, University of Rijeka
- Investigators
- Stjepan Spalj, Study director, University of Rijeka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455634
- Sponsor's protocol ID
- 2170-24-01-15-2
- Other IDs
- 2170-29-02/1-14-5, 13.06.2.1.53, uniri-biomed-18-22, IP9
- Acronym
- PONCOS
- Status last verified
- May 2022
- First submitted
- 21 Feb 2018
- Last updated
- 26 May 2022
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Brumini M, Slaj M, Katic V, Pavlic A, Trinajstic Zrinski M, Spalj S. Parental influence is the most important predictor of child's orthodontic treatment demand in a preadolescent age. Odontology. 2020 Jan;108(1):109-116. doi: 10.1007/s10266-019-00447-1. Epub 2019 Aug 23.
PubMed 31444594Acev DP, Brumini M, Slaj M, Katic V, Spalj S. Child Perceptions Questionnaire in Croatia: Two Domains for Measuring Oral Health. Acta Stomatol Croat. 2019 Mar;53(1):47-54. doi: 10.15644/asc53/1/5.
PubMed 31118532Uhac M, Zibar Belasic T, Perkovic V, Zigante M, Spalj S. Validation of the Parental-Caregivers Perception Questionnaire (P-CPQ) in Croatia. Abstract book 6th Congress of School of Dental Medicine, University of Zagreb. Acta Stomatol Croat. 2020;54:210:212.
Brumini M, Uhac M, Zibar Belasic T, Spalj S. Parental attitude and emotional well-being mediate orthodontic treatment demand in adolescents. Abstract book 6th Congress of School of Dental Medicine, University of Zagreb. Acta Stomatol Croat. 2020;54:210:212-3.
Brumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.
Uhac M, Zibar Belasic T, Perkovic V, Matijevic M, Spalj S. Orthodontic treatment demand in young adolescents - Are parents familiar with their children's desires and reasons? Int J Paediatr Dent. 2022 May;32(3):383-391. doi: 10.1111/ipd.12893. Epub 2021 Nov 28.
PubMed 34402117Uhač M, Zibar Belašić T, Perković V, Matijević M, Špalj S. Orthodontic treatment demand in young adolescents - comparison of parents and their children. 7. Međunarodni kongres Stomatološkog fakulteta Sveučilišta u Zagrebu. Acta Stomatologica Croatica. Rovinj, Hrvatska, 21.-22.05.2021.
Spalj S, Uhac M, Brumini M. Role of parents in patient compliance during class II division 1 malocclusion. 51st SIDO International Congress on-line. 13-14.11.2020.
Marijanović M, Uhač M, Žigante M, Špalj S. Validation of the Family Impact Scale (FIS) in Croatia. 1. Kongres Fakulteta dentalne medicine u Rijeci. 1. i 2. listopada 2020.
Brumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.
Uhač M, Žigante M, Špalj S. Early Childhood Oral Health Impact Scale and orthodontics: cross-cultural adaptation in Croatia. 51st SIDO International Congress on-line. 13-14.11.2020.
Cukaj Ademi H, Zigante M, Premaraj Thyagaseely S, Tudor V, Palomo JM, Spalj S. Mandibular Advancement in Dentofacial Orthopaedics: Effects on Pharyngeal Airway, Dentoskeletal Characteristics and Quality of Life: A Randomised Controlled Trial. Orthod Craniofac Res. 2026 Feb;29(1):122-133. doi: 10.1111/ocr.70056. Epub 2025 Nov 10.
PubMed 41211711
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Malocclusion Class II/1 - Predictors for Seeking, Compliance and Outcome
- ClinicalTrials.gov ID
- NCT03455634
- Acronym / sponsor ID
- PONCOS / 2170-24-01-15-2
- Conditions
- Malocclusion, Angle Class II
- Keywords
- quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Visnja KaticUniversity, hospital or other
- Collaborators
- Clinical Hospital Center Rijeka, University of Rijeka
- Study start
- 9 Feb 2015 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 6 Mar 2018 (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.
Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic treatment, drop-out from orthodontic treatment and success of orthodontic treatment.
Methods: evaluation before, during and at the end of orthodontic treatment. Clinical and diagnostic evaluation of complexity before and at the end of orthodontic treatment, evaluation of awareness of treatment need, impact on social and psychological aspects, functional disturbances, impact of malocclusion on quality of life, social interaction, ability to perform daily activities.
Detailed description
Data will include diagnostic measurements on study casts, x-rays, and data from questionnaires given to children and parents. Statistical analyses will explore predictors of treatment success with treatment need, compliance and psycho-social domains.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Twin Block | Active comparator | Device: Twin BlockTwin Block functional appliance |
| Sander | Active comparator | Device: Sander bite jumping applianceSander bite jumping appliance |
| Control | No intervention | –no intervention |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- distal molar occlusion, overjet >5 mm, cervical vertebral maturation method stages (CS) -CS2, CS3 or CS4
Key exclusion criteria (1 listed)
- mental retardation
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 |
|---|---|---|
| Twin Blockfunctional appliances for the stimulation of the mandibular growth | Device | Twin Block |
| Sander bite jumping appliancefunctional appliances for the stimulation of the mandibular growth | Device | Sander |
Primary outcome
Overjet
Time frame: baseline
sagittal distance between upper and lower anterior teeth measured in mm
Child perception questionnaire age 11-14 (CPQ 11-14 SF16) , subscale measuring oral symptoms
Time frame: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of oral symptoms on quality of life
subscale functional limitations of CPQ 11-14 SF16
Time frame: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of functional limitations on quality of life
subscale emotional well-being of CPQ 11-14 SF16
Time frame: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of emotional wee-being on quality of life
subscale social well-being of CPQ 11-14 SF 16
Time frame: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-16, higher score means greater impact of social well-being on quality of life
Self-perceived satisfaction with dental appearance
Time frame: baseline
rating scale, answer on 5-point Likert scale (0-4), higher score means greater satisfaction with dental apperance
Self-perceived treatment need
Time frame: baseline
rating scale, answers on 5-point Likert scale (0-4), higher score means greater self-perceived treatment need
overall score of CPQ 11-14 SF 16 and SF8
Time frame: baseline
CPQ 11-14, answers on 5-point Likert scale (0-4), score range 0-32 for SF8 and 0-64 for SF16 (sum of all items in short-form 8 and 16 instruments), higher score means higher impact of oral disorders on quality of life
change in overjet
Time frame: change from baseline to one year of appliance wear
sagittal distance between upper and lower anterior teeth measured in mm
18 secondary outcomes
Parental-Caregiver Perceptions Questionnaire (P CPQ), subscale oral symptoms
Time frame: baseline
P CPQ, subscale functional limitations
Time frame: baseline
P CPQ, subscale emotional well-being
Time frame: baseline
P CPQ, subscale social well-being
Time frame: baseline
overall score of P CPQ
Time frame: baseline
parental/family activity subscale of Family Impact Scale (FIS) questionnaire
Time frame: baseline
parental emotions subscale of FIS
Time frame: baseline
family conflict subscale of FIS
Time frame: baseline
financial burden subscale of FIS
Time frame: baseline
overall score of FIS
Time frame: baseline
change in oral symptoms of CPQ 11-14 SF16
Time frame: change from baseline to one year of appliance wear
change in functional limitations of CPQ
Time frame: change from baseline to one year of appliance wear
change in emotional well-being of CPQ
Time frame: change from baseline to one year of appliance wear
change in social well-being of CPQ
Time frame: change from baseline to one year of appliance wear
change in overall score of CPQ SF8
Time frame: change from baseline to one year of appliance wear
validation of CPQ 11-14 in Croatia
Time frame: one year
validation of P CPQ in Croatia
Time frame: one year
validation of FIS in Croatia
Time frame: one year
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 26 May 2022.
- Results publication: PubMed 31444594Brumini M, Slaj M, Katic V, Pavlic A, Trinajstic Zrinski M, Spalj S. Parental influence is the most important predictor of child's orthodontic treatment demand in a preadolescent age. Odontology. 2020 Jan;108(1):109-116. doi: 10.1007/s10266-019-00447-1. Epub 2019 Aug 23.
- Results publication: PubMed 31118532Acev DP, Brumini M, Slaj M, Katic V, Spalj S. Child Perceptions Questionnaire in Croatia: Two Domains for Measuring Oral Health. Acta Stomatol Croat. 2019 Mar;53(1):47-54. doi: 10.15644/asc53/1/5.
- Results publicationUhac M, Zibar Belasic T, Perkovic V, Zigante M, Spalj S. Validation of the Parental-Caregivers Perception Questionnaire (P-CPQ) in Croatia. Abstract book 6th Congress of School of Dental Medicine, University of Zagreb. Acta Stomatol Croat. 2020;54:210:212.
- Results publicationBrumini M, Uhac M, Zibar Belasic T, Spalj S. Parental attitude and emotional well-being mediate orthodontic treatment demand in adolescents. Abstract book 6th Congress of School of Dental Medicine, University of Zagreb. Acta Stomatol Croat. 2020;54:210:212-3.
- Results publicationBrumini M. Predictors of orthodontic treatment demand in early adolescence (dissertation). Rijeka; University of Rijeka, Faculty of Medicine: 2020.
- Results publication: PubMed 34402117Uhac M, Zibar Belasic T, Perkovic V, Matijevic M, Spalj S. Orthodontic treatment demand in young adolescents - Are parents familiar with their children's desires and reasons? Int J Paediatr Dent. 2022 May;32(3):383-391. doi: 10.1111/ipd.12893. Epub 2021 Nov 28.
- Results publicationUhač M, Zibar Belašić T, Perković V, Matijević M, Špalj S. Orthodontic treatment demand in young adolescents - comparison of parents and their children. 7. Međunarodni kongres Stomatološkog fakulteta Sveučilišta u Zagrebu. Acta Stomatologica Croatica. Rovinj, Hrvatska, 21.-22.05.2021.
- Results publicationSpalj S, Uhac M, Brumini M. Role of parents in patient compliance during class II division 1 malocclusion. 51st SIDO International Congress on-line. 13-14.11.2020.
- Results publicationMarijanović M, Uhač M, Žigante M, Špalj S. Validation of the Family Impact Scale (FIS) in Croatia. 1. Kongres Fakulteta dentalne medicine u Rijeci. 1. i 2. listopada 2020.
- Results publicationBrumini M, Špalj S. Child Perceptions Questionnaire - validation protocol. 8th Virtual world congress of dental students. Zagreb, 20.-22.05.2020.
- Results publicationUhač M, Žigante M, Špalj S. Early Childhood Oral Health Impact Scale and orthodontics: cross-cultural adaptation in Croatia. 51st SIDO International Congress on-line. 13-14.11.2020.
- Derived from this study: PubMed 41211711Cukaj Ademi H, Zigante M, Premaraj Thyagaseely S, Tudor V, Palomo JM, Spalj S. Mandibular Advancement in Dentofacial Orthopaedics: Effects on Pharyngeal Airway, Dentoskeletal Characteristics and Quality of Life: A Randomised Controlled Trial. Orthod Craniofac Res. 2026 Feb;29(1):122-133. doi: 10.1111/ocr.70056. Epub 2025 Nov 10.
- Individual participant dataSharing planned: Undecided
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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.
Stjepan Spalj study director
University of Rijeka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twin Block and Sander bite jumping appliance in people with Malocclusion, Angle Class II, run by Visnja Katic at 1 site in Croatia.
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 1 inclusion and 1 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 26 May 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 Croatia. 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?
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?
Overjet (time frame: baseline). The study lists 9 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 NCT03455634, which also lists 12 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 26 May 2022.