GingivitisNCT06510179
Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients
A study testing Toothbrushing in people with Gingivitis and Orthodontics, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the effectiveness of different toothbrushes in patients with fixed orthodontic appliances who have gingival inflammation. The main questions it aims to answer are: 1. Is a single-tufted toothbrush as effective as orthodontic or conventional toothbrushes? 2. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Gingivitis, Orthodontics
- What is being tested?
- Toothbrushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 30 Apr 2024
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients who had at least 22 teeth with brackets (excluding third molars)
- 18-35 yo
- had a diagnosis of dental plaque biofilm-induced gingivitis defined as ≥10% of --sites with bleeding on probing (BoP) and mean probing depth (PD) ≤3 mm
- were systemically healthy, non-smokers, or smoked \<10 cigarettes per day for at least five years
- had not used antibiotics for the last three months
- were not pregnant.
Who cannot join
- patients who smoked ≥ 10 cigarettes per day for at least five years
- who had less than 26 teeth with brackets
- were younger than 18 years of age or older than 35 years of age
- were periodontally healthy or had periodontitis
- who had systemic disease
- had used antibiotics in the last three months were pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Okan University Dental Hospital
Istanbul, Tuzla, 34947
About this study
Official title: Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients With Gingivitis: a Randomized Controlled Study
The goal of this clinical trial is to compare the effectiveness of different toothbrushes in patients with fixed orthodontic appliances who have gingival inflammation. The main questions it aims to answer are:
- Is a single-tufted toothbrush as effective as orthodontic or conventional toothbrushes?
- What are the effects of these toothbrushes on dental biofilm removal and gingival inflammation? Researchers will compare conventional toothbrushes, orthodontic toothbrushes, and single-tufted toothbrushes after professional mechanical debridement and oral hygiene instruction.
Read more
Participants will:
- Receive nonsurgical periodontal therapy
- According to the group they are involved, they will receive an oral hygiene kit (toothbrush and toothpaste) and instruction
- They will participate in the recalls in the first week, sixth week, and third month.
Read the detailed description
Fixed orthodontic treatment is often the preferred method for the treatment of malocclusion and involves using complex devices like brackets and arch wires. These devices create areas that retain plaque, making effective plaque removal more challenging. Studies have shown that patients with fixed orthodontic appliances tend to have increased plaque accumulation.1,2 These patients are more susceptible to gingival inflammation due to this plaque-accumulating environment. The essential role of dental biofilm in gingivitis is well-documented, and removing biofilm can reverse the condition.3 Previous animal studies on dentition with reduced periodontium have shown that orthodontic forces and tooth movements do not induce gingival inflammation without plaque.4-7 However, in the presence of plaque, similar forces can result in vertical bone defects and attachment loss, especially with tipping and intruding movements.4 Effective dental biofilm control is crucial for improving oral hygiene especially in orthodontic patients.
Orthodontic patients face challenges with mechanical plaque removal, requiring various strategies to control plaque formation, prevent gingivitis, and maintain the periodontal health.8 Mechanical plaque removal with toothbrushes and interdental devices is the most common method for controlling plaque at home. Most patients prefer manual toothbrushes, whether conventional or orthodontic, due to their lower cost and ease of use. Although powered toothbrushes are more effective than manual ones in reducing plaque and gingivitis both short and long term in non-orthodontic patients, the effectiveness of powered versus manual toothbrushes is still uncertain for the orthodontic patients. A recent systematic review and meta-analysis concluded that there was no significant difference between manual and powered toothbrushes in reducing plaque accumulation or gingivitis in patients with fixed orthodontic devices.9 Selecting oral hygiene instruments that are most appropriate for each patient\'s specific needs is crucial for motivating orthodontic patients. Manual orthodontic toothbrushes have undergone advancements in bristle design and material. Many types of toothbrush options have been promoted for orthodontic patients. The use of orthodontic toothbrushes is currently preferred over other types of toothbrushes due to their bristle design, which makes it easier to clean the area around the brackets. Since orthodontic toothbrushes typically feature a V-shaped groove, while the shorter bristles within the groove are designed to clean the middle bracket area, the longer bristles are intended to clean the surroundings of the brackets. Studies comparing the effectiveness of orthodontic and conventional toothbrushes in reducing plaque and gingivitis on teeth with fixed appliances have shown conflicting results.8,10-12 More recently, single-tufted brushes have been investigated for their effectiveness in plaque removal. Single-tufted toothbrushes are recommended as an adjunctive device for surfaces and areas of the teeth that are not easily reached with other oral hygiene devices, such as the distal surfaces of molars, furcation areas, irregular gingival margins and areas of crowded teeth.13,14 Hasegawa et al., who first compared the effectiveness of single-tufted toothbrushes with the golden standard conventional toothbrush in controlling newly formed biofilm in the dentogingival area of healthy individuals, found it effective at controlling short-term dental biofilm neoformation on the dentogingival area.15 There are limited studies comparing the plaque removal efficacy of single-tufted brushes with conventional toothbrushes15,16, and one study has investigated in orthodontic patients.17 However, none of them has monitored their periodontal health in the long term and have compared single-tufted toothbrushes with conventional and orthodontic toothbrushes together. It was hypothesized that single-tufted toothbrushes are more effective in plaque removal and the healing of gingival inflammation than conventional toothbrushes and as effective as orthodontic toothbrushes. Therefore, it was aimed to evaluate the long-term effectiveness of different toothbrushes in removing plaque and gingival inflammation in individuals under fixed orthodontic treatment for gingivitis.
- Conditions
- Gingivitis, Orthodontics
- Being tested
- Toothbrushing
- Keywords
- orthodontic appliances, oral hygiene, toothbrushing, gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothbrushingOther
Patients brush their teeth using the technique instructed to them using the toothbrush provided.
| Study group | Role | What they receive |
|---|---|---|
| Conventional toothbrush group | Active comparator | Patients are instructed with the modified Bass technique. In this technique, the toothbrush bristles are positioned 45° to the long axis of the tooth towards the base of the tooth at the gum line with a gentle back-and-forth rolling motion, then swept towards the occlusal surface of the teeth. To adapt to orthodontic braces, the same movement is repeated with the bristles positioned just occlusal to the brackets. Receives: Other: Toothbrushing |
| Orthodontic toothbrush group | Experimental | The patients in this group are instructed to brush with the Bass technique. In this technique, the toothbrush is placed on the gingival margin with its bristles at 45° to the long axis of the tooth. It is demonstrated by making back-and-forth movements and vibrating the brush at short intervals without lifting the bristles. Receives: Other: Toothbrushing |
| Single-tufted toothbrush group | Experimental | In this group, a single-tooth circular brushing technique first developed by Jiri Sedelmayer was explained, and dental plaque removal is demonstrated with circular movements around the brackets and following the gingival margin of each tooth. Receives: Other: Toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival inflammation
Löe \& Silnesss Gingival index
Measured: at the baseline, first week, sixth week and third month
bleeding on probing
bleeding on probing
Measured: at the baseline, first week, sixth week and third month
Secondary outcomes (1)
Dental biofilm
Turesky modification of Quigley-Hein plaque Index
Measured: at the baseline, first week, sixth week and third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Aug 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will randomly allocate one of three groups (Conventional toothbrush group, orthodontic toothbrush group, or single-tufted toothbrush group).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GOKCE AYKOL SAHIN, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510179
- Sponsor's protocol ID
- 2023/30 Rev-1/ 681
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The authors have not yet decided on data sharing. Revisions will be made when it is determined on which website it can be published.
Publications
Lee DW, Moon IS. The plaque-removing efficacy of a single-tufted brush on the lingual and buccal surfaces of the molars. J Periodontal Implant Sci. 2011 Jun;41(3):131-4. doi: 10.5051/jpis.2011.41.3.131. Epub 2011 Jun 30.
PubMed 21811688Rafe Z, Vardimon A, Ashkenazi M. Comparative study of 3 types of toothbrushes in patients with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):92-5. doi: 10.1016/j.ajodo.2006.01.018.
PubMed 16849078ElShehaby M, Mofti B, Montasser MA, Bearn D. Powered vs manual tooth brushing in patients with fixed orthodontic appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2020 Nov;158(5):639-649. doi: 10.1016/j.ajodo.2020.04.018. Epub 2020 Sep 17.
PubMed 32951930Ericsson I, Thilander B, Lindhe J. Periodontal conditions after orthodontic tooth movements in the dog. Angle Orthod. 1978 Jul;48(3):210-8. doi: 10.1043/0003-3219(1978)0482.0.CO;2. No abstract available.
PubMed 280130Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.
PubMed 15312097Diamanti-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol. 1987 Jul;14(6):326-33. doi: 10.1111/j.1600-051x.1987.tb00979.x.
PubMed 3509967Zachrisson S, Zachrisson BU. Gingival condition associated with orthodontic treatment. Angle Orthod. 1972 Jan;42(1):26-34. doi: 10.1043/0003-3219(1972)0422.0.CO;2. No abstract available.
PubMed 4500561Aykol-Sahin G, Ay-Kocabas B, Mert B, Usta H. Effectiveness of different types of toothbrushes on periodontal health in orthodontic patients with gingivitis: A randomized controlled study. BMC Oral Health. 2024 Oct 25;24(1):1289. doi: 10.1186/s12903-024-05084-x.
PubMed 39455996
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Types of Toothbrushes on Periodontal Health in Orthodontic Patients With Gingivitis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06510179
- Acronym / sponsor ID
- 2023/30 Rev-1/ 681
- Conditions
- Gingivitis, Orthodontics
- Keywords
- orthodontic appliances, oral hygiene, toothbrushing, gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effectiveness of different toothbrushes in patients with fixed orthodontic appliances who have gingival inflammation. The main questions it aims to answer are:
- Is a single-tufted toothbrush as effective as orthodontic or conventional toothbrushes?
- What are the effects of these toothbrushes on dental biofilm removal and gingival inflammation? Researchers will compare conventional toothbrushes, orthodontic toothbrushes, and single-tufted toothbrushes after professional mechanical debridement and oral hygiene instruction.
Participants will:
- Receive nonsurgical periodontal therapy
- According to the group they are involved, they will receive an oral hygiene kit (toothbrush and toothpaste) and instruction
- They will participate in the recalls in the first week, sixth week, and third month.
Detailed description
Fixed orthodontic treatment is often the preferred method for the treatment of malocclusion and involves using complex devices like brackets and arch wires. These devices create areas that retain plaque, making effective plaque removal more challenging. Studies have shown that patients with fixed orthodontic appliances tend to have increased plaque accumulation.1,2 These patients are more susceptible to gingival inflammation due to this plaque-accumulating environment. The essential role of dental biofilm in gingivitis is well-documented, and removing biofilm can reverse the condition.3 Previous animal studies on dentition with reduced periodontium have shown that orthodontic forces and tooth movements do not induce gingival inflammation without plaque.4-7 However, in the presence of plaque, similar forces can result in vertical bone defects and attachment loss, especially with tipping and intruding movements.4 Effective dental biofilm control is crucial for improving oral hygiene especially in orthodontic patients.
Orthodontic patients face challenges with mechanical plaque removal, requiring various strategies to control plaque formation, prevent gingivitis, and maintain the periodontal health.8 Mechanical plaque removal with toothbrushes and interdental devices is the most common method for controlling plaque at home. Most patients prefer manual toothbrushes, whether conventional or orthodontic, due to their lower cost and ease of use. Although powered toothbrushes are more effective than manual ones in reducing plaque and gingivitis both short and long term in non-orthodontic patients, the effectiveness of powered versus manual toothbrushes is still uncertain for the orthodontic patients. A recent systematic review and meta-analysis concluded that there was no significant difference between manual and powered toothbrushes in reducing plaque accumulation or gingivitis in patients with fixed orthodontic devices.9 Selecting oral hygiene instruments that are most appropriate for each patient\'s specific needs is crucial for motivating orthodontic patients. Manual orthodontic toothbrushes have undergone advancements in bristle design and material. Many types of toothbrush options have been promoted for orthodontic patients. The use of orthodontic toothbrushes is currently preferred over other types of toothbrushes due to their bristle design, which makes it easier to clean the area around the brackets. Since orthodontic toothbrushes typically feature a V-shaped groove, while the shorter bristles within the groove are designed to clean the middle bracket area, the longer bristles are intended to clean the surroundings of the brackets. Studies comparing the effectiveness of orthodontic and conventional toothbrushes in reducing plaque and gingivitis on teeth with fixed appliances have shown conflicting results.8,10-12 More recently, single-tufted brushes have been investigated for their effectiveness in plaque removal. Single-tufted toothbrushes are recommended as an adjunctive device for surfaces and areas of the teeth that are not easily reached with other oral hygiene devices, such as the distal surfaces of molars, furcation areas, irregular gingival margins and areas of crowded teeth.13,14 Hasegawa et al., who first compared the effectiveness of single-tufted toothbrushes with the golden standard conventional toothbrush in controlling newly formed biofilm in the dentogingival area of healthy individuals, found it effective at controlling short-term dental biofilm neoformation on the dentogingival area.15 There are limited studies comparing the plaque removal efficacy of single-tufted brushes with conventional toothbrushes15,16, and one study has investigated in orthodontic patients.17 However, none of them has monitored their periodontal health in the long term and have compared single-tufted toothbrushes with conventional and orthodontic toothbrushes together. It was hypothesized that single-tufted toothbrushes are more effective in plaque removal and the healing of gingival inflammation than conventional toothbrushes and as effective as orthodontic toothbrushes. Therefore, it was aimed to evaluate the long-term effectiveness of different toothbrushes in removing plaque and gingival inflammation in individuals under fixed orthodontic treatment for gingivitis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Patients will randomly allocate one of three groups (Conventional toothbrush group, orthodontic toothbrush group, or single-tufted toothbrush group).
| Arm | Type | Receives |
|---|---|---|
| Conventional toothbrush group | Active comparator | Other: ToothbrushingPatients are instructed with the modified Bass technique. In this technique, the toothbrush bristles are positioned 45° to the long axis of the tooth towards the base of the tooth at the gum line with a gentle back-and-forth rolling motion, then swept towards the occlusal surface of the teeth. To adapt to orthodontic braces, the same movement is repeated with the bristles positioned just occlusal to the brackets. |
| Orthodontic toothbrush group | Experimental | Other: ToothbrushingThe patients in this group are instructed to brush with the Bass technique. In this technique, the toothbrush is placed on the gingival margin with its bristles at 45° to the long axis of the tooth. It is demonstrated by making back-and-forth movements and vibrating the brush at short intervals without lifting the bristles. |
| Single-tufted toothbrush group | Experimental | Other: ToothbrushingIn this group, a single-tooth circular brushing technique first developed by Jiri Sedelmayer was explained, and dental plaque removal is demonstrated with circular movements around the brackets and following the gingival margin of each tooth. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- patients who had at least 22 teeth with brackets (excluding third molars)
- 18-35 yo
- had a diagnosis of dental plaque biofilm-induced gingivitis defined as ≥10% of --sites with bleeding on probing (BoP) and mean probing depth (PD) ≤3 mm
- were systemically healthy, non-smokers, or smoked \<10 cigarettes per day for at least five years
- had not used antibiotics for the last three months
Key exclusion criteria (6 listed)
- patients who smoked ≥ 10 cigarettes per day for at least five years
- who had less than 26 teeth with brackets
- were younger than 18 years of age or older than 35 years of age
- were periodontally healthy or had periodontitis
- who had systemic disease
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 |
|---|---|---|
| ToothbrushingPatients brush their teeth using the technique instructed to them using the toothbrush provided. | Other | Conventional toothbrush group, Orthodontic toothbrush group, Single-tufted toothbrush group |
Primary outcome
Gingival inflammation
Time frame: at the baseline, first week, sixth week and third month
Löe \& Silnesss Gingival index
bleeding on probing
Time frame: at the baseline, first week, sixth week and third month
bleeding on probing
1 secondary outcome
Dental biofilm
Time frame: at the baseline, first week, sixth week and third month
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 19 Jul 2024.
- Results publication: PubMed 21811688Lee DW, Moon IS. The plaque-removing efficacy of a single-tufted brush on the lingual and buccal surfaces of the molars. J Periodontal Implant Sci. 2011 Jun;41(3):131-4. doi: 10.5051/jpis.2011.41.3.131. Epub 2011 Jun 30.
- Results publication: PubMed 16849078Rafe Z, Vardimon A, Ashkenazi M. Comparative study of 3 types of toothbrushes in patients with fixed orthodontic appliances. Am J Orthod Dentofacial Orthop. 2006 Jul;130(1):92-5. doi: 10.1016/j.ajodo.2006.01.018.
- Results publication: PubMed 32951930ElShehaby M, Mofti B, Montasser MA, Bearn D. Powered vs manual tooth brushing in patients with fixed orthodontic appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2020 Nov;158(5):639-649. doi: 10.1016/j.ajodo.2020.04.018. Epub 2020 Sep 17.
- Results publication: PubMed 280130Ericsson I, Thilander B, Lindhe J. Periodontal conditions after orthodontic tooth movements in the dog. Angle Orthod. 1978 Jul;48(3):210-8. doi: 10.1043/0003-3219(1978)0482.0.CO;2. No abstract available.
- Results publication: PubMed 15312097Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol. 2004 Sep;31(9):749-57. doi: 10.1111/j.1600-051X.2004.00563.x.
- Results publication: PubMed 3509967Diamanti-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol. 1987 Jul;14(6):326-33. doi: 10.1111/j.1600-051x.1987.tb00979.x.
- Results publication: PubMed 4500561Zachrisson S, Zachrisson BU. Gingival condition associated with orthodontic treatment. Angle Orthod. 1972 Jan;42(1):26-34. doi: 10.1043/0003-3219(1972)0422.0.CO;2. No abstract available.
- Derived from this study: PubMed 39455996Aykol-Sahin G, Ay-Kocabas B, Mert B, Usta H. Effectiveness of different types of toothbrushes on periodontal health in orthodontic patients with gingivitis: A randomized controlled study. BMC Oral Health. 2024 Oct 25;24(1):1289. doi: 10.1186/s12903-024-05084-x.
- Individual participant dataSharing planned: Undecided. The authors have not yet decided on data sharing. Revisions will be made when it is determined on which website it can be published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrushing in people with Gingivitis and Orthodontics, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. 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 Turkey (Türkiye). 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?
Gingival inflammation (time frame: at the baseline, first week, sixth week and third month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510179, which also lists 8 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 19 Jul 2024.