Class II Division 1 MalocclusionNCT06873490
External Root Resorption and Periodontal Status During Retraction of the Upper Anterior Teeth
A study testing Electric stimulation removabel device and Traditional retraction method. in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
This RCT will include 34 patients requiring en-masse retraction of upper anterior teeth after maxillary first premolars extraction. Patients accepted into the study will be randomly assigned to one of two groups in a 1:1 allocation ratio: the electrically stimulated en-masse retraction group (ESER) and the… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Electric stimulation removabel device and Traditional retraction method.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSyria
- Study dates
- 1 Nov 2023to 15 Dec 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy adult patients, Male and female, Age range: 18-25 years.
- Class II Division 1 malocclusion :
- Mild/moderate skeletal Class II (ANB= 5-7 degrees)
- Overjet ≤10
- Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
- Permanent occlusion.
Show all 12Show fewer
- The Existence of all the upper teeth (except third molars).
- Good oral and periodontal health:
- Probing depth < 4 mm
- No radiographic evidence of bone loss.
- Gingival index ≤ 1
- Plaque index ≤ 1
Who cannot join
- Medical problems that affect tooth movement, such as corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs).
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm Radiographic evidence of bone loss Gingival index > 1 Plaque index > 1
- Patient had previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Damascus, DM20AM19
About this study
Official title: Evaluation of the External Apical Root Resorption and the Periodontal Indices After the En-masse Retraction of the Upper Anterior Teeth Stimulated by Low-intensity Electrical Stimulation: a Randomized Controlled Trial
This RCT will include 34 patients requiring en-masse retraction of upper anterior teeth after maxillary first premolars extraction.
Patients accepted into the study will be randomly assigned to one of two groups in a 1:1 allocation ratio: the electrically stimulated en-masse retraction group (ESER) and the conventional en-masse retraction group (CER). In both groups, the upper anterior teeth will be retracted en masse by applying 250 g of force on each side using closed nickel-titanium coil springs. Mini-implants will be used to provide the maximum anchorage.
The outcomes of the study will be the external apical root resorption (EARR) and the periodontal status of the upper anterior teeth during the treatment stages.
Read the detailed description
Young adult patients who visit the Department of Orthodontics at Damascus University-Faculty of Dentistry during the sample collection period will be examined to determine the orthodontic treatment plan. Written informed consent will be obtained from all patients who meet the inclusion criteria and accept to participate in the trial.
Before starting the leveling and alignment procedures on the maxillary dental arch, skeletal anchorage will be secure on the maxillary dental arch using self-drilling mini-implants (1.6 * 8 mm; 3S screw, Hubit™, Seoul, Korea) that will apply between the roots of the maxillary first molars and the second premolars. The patients will be referred for maxillary first premolars extraction at the Department of Maxillofacial Surgery, Damascus University, Faculty of Dentistry.
This study will use fixed orthodontic appliances with an MBT prescription and a 0.022-inch bracket slot (VotionTM, Ortho Technology, Florida, USA). The two groups will follow a uniform wire sequence starting from a 0.014-inch NiTi wire until they reach the 0.019*0.025-inch stainless steel basic archwire, with a 3-week interval between each wire.
The sliding technique will be used for en-masse retraction in both study groups. An orthodontic force of approximately 500 g (250 g on each side) will be applied to the crimpable hooks using bilateral closed coil nickel titanium springs (NT3 closed coil springs, American Orthodontics, Sheboygan, Wisconsin) anchored to orthodontic mini-screws. Patients will be followed up every 2 weeks during this phase to adjust the springs to maintain a constant force. The endpoint of en-masse retraction in both groups will be determined when the maxillary canines achieve a Class I relationship with the mandible and a normal incisor relationship.
The removable electrical stimulation device utilized in the study by Shaadouh et al.. to provide the electrical stimulation will be used in this trial for the same purpose.
Each patient in the low-intensity electrical stimulation group will be asked to wear a removable device for five hours daily until the completion of the retraction of the upper anterior teeth.
To evaluate external apical root resorption (EARR), digital panoramic radiographs will be taken at three time points: before orthodontic treatment (T0), before en-masse retraction (T1), and after en-masse retraction (T2). The ImageJ software (NIH and LOCI, Madison, Wisconsin, USA) was used to analyze these radiographs. The method, originally described by Linge and Linge will be used to calculate the root resorption.
The gingival index (GI), the papillary bleeding index (PBI), and the dental plaque index (DPI) will be measured on the upper anterior teeth at the previous assessment times.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Electric stimulation removabel device, Traditional retraction method.
- 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.
Electric stimulation removabel deviceDevice
The device will be used to stimulate orthodontic tooth movement through a specific design used to deliver the current to the mucosa around the teeth being retracted.
Traditional retraction method.Procedure or surgery
In this intervention, the upper anterior teeth will be retracted together backward using the traditional retraction method. No acceleration devices will be used in conjunction with this procedure.
| Study group | Role | What they receive |
|---|---|---|
| Electric stimulation with retraction | Experimental | Electric current will be applied in this group of patients using a removable device. Receives: Device: Electric stimulation removabel device |
| Traditional retraction | Active comparator | No acceleration method will be performed in this group. Only the traditional method of retraction will be followed. Receives: Procedure: Traditional retraction method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in external apical root resorption
The root length will be measured for each root of six upper anterior teeth. The method originally described by Linge and Linge will be used. The amount of root resorption (in millimeters) will be calculated using the following equation: Root Resorption = Root Length (T0) - (Root Length (T1) × Correction Factor). The Correction Factor will be calculated by dividing the crown Length (T0) to the crown Length (T1).
Measured: The digital panoramic radiographs will be taken at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Secondary outcomes (4)
Change in the Gingival Index
Assessment will be performed using a gingival probe according to Silness and Loe.
(0) = Normal gingiva.
- = Mild inflammation: slight color change, slight edema. No bleeding on probing.
- = Moderate inflammation: redness, edema and glazing. Bleeding on probing.
- = Sever inflammation: marked redness and edema, ulceration, and tendency to spontaneous bleeding
Measured: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Change in the Dental Plaque index
Assessment will be performed using a gingival probe according to Silness and Loe.
(0) = No plaque.
- = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after disclosing solution or using the probe on the tooth surface.
- = Moderate accumulation of soft deposits within the gingival pocket, or on the tooth and gingival margin, which can be seen with the naked eye.
- = Abundance of soft matter within the gingival pocket and/or the tooth and gingival margin.
Measured: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Change in the Bleeding Index
The Bleeding index will be used to assess the status of periodontal tissues and the amount of congestion in the gingival margins around the anterior teeth.
According to Muhlemann, an assessment will be performed using a gingival probe. (0) = No bleeding.
- = A single discrete bleeding point appears.
- = Several isolated bleeding points or a single fine line of blood appears.
- = The interdental triangle fills with blood shortly after probing.
- = Profuse bleeding occurs after probing; blood flows immediately into the marginal sulcus.
Measured: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Change in Gingival Recession
This will be measured in millimeters from the cement-enamel junction to the gingival margin level around the six anterior teeth.
Measured: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Nov 2023
- Primary completion13 Mar 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Class II Division 1 MalocclusionStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rashad Ibrahem Shaadouh, DDS MSc, Principal investigator, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873490
- Sponsor's protocol ID
- UDDS-Ortho-2-2025
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaadouh RI, Hajeer MY, Al-Sabbagh R, Alam MK, Mahmoud G, Idris G. A Novel Method to Accelerate Orthodontic Tooth Movement Using Low-Intensity Direct Electrical Current in Patients Requiring en-Masse Retraction of the Upper Anterior Teeth: A Preliminary Clinical Report. Cureus. 2023 May 24;15(5):e39438. doi: 10.7759/cureus.39438. eCollection 2023 May.
PubMed 37234453Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. II. Increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current. Am J Orthod. 1980 Jan;77(1):33-47. doi: 10.1016/0002-9416(80)90222-5.
PubMed 6243448Spadari GS, Zaniboni E, Vedovello SA, Santamaria MP, do Amaral ME, Dos Santos GM, Esquisatto MA, Mendonca FA, Santamaria M Jr. Electrical stimulation enhances tissue reorganization during orthodontic tooth movement in rats. Clin Oral Investig. 2017 Jan;21(1):111-120. doi: 10.1007/s00784-016-1759-6. Epub 2016 Feb 26.
PubMed 26917494Shaadouh RI, Hajeer MY, Awawdeh MA, Jaber ST, Mahmoud GA, Almasri IA. Effectiveness of low-intensity electrical current in accelerating the en-masse retraction of the upper anterior teeth following first-premolar extraction in young adult patients with Class II division 1 malocclusion: A randomized controlled clinical trial. Int Orthod. 2024 Dec;22(4):100921. doi: 10.1016/j.ortho.2024.100921. Epub 2024 Sep 23.
PubMed 39316889Shaadouh RI, Hajeer MY, Alam MK, Jaber ST. Effect of Low-Intensity Electrical Stimulation on External Apical Root Resorption and Periodontal Indices Following En-Masse Retraction of Upper Anterior Teeth in Young Adults: A Randomized Controlled Trial. Clin Exp Dent Res. 2025 Aug;11(4):e70188. doi: 10.1002/cre2.70188.
PubMed 40762524
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the External Apical Root Resorption and the Periodontal Indices After the En-masse Retraction of the Upper Anterior Teeth Stimulated by Low-intensity Electrical Stimulation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06873490
- Acronym / sponsor ID
- UDDS-Ortho-2-2025
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 12 Mar 2025 (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.
This RCT will include 34 patients requiring en-masse retraction of upper anterior teeth after maxillary first premolars extraction.
Patients accepted into the study will be randomly assigned to one of two groups in a 1:1 allocation ratio: the electrically stimulated en-masse retraction group (ESER) and the conventional en-masse retraction group (CER). In both groups, the upper anterior teeth will be retracted en masse by applying 250 g of force on each side using closed nickel-titanium coil springs. Mini-implants will be used to provide the maximum anchorage.
The outcomes of the study will be the external apical root resorption (EARR) and the periodontal status of the upper anterior teeth during the treatment stages.
Detailed description
Young adult patients who visit the Department of Orthodontics at Damascus University-Faculty of Dentistry during the sample collection period will be examined to determine the orthodontic treatment plan. Written informed consent will be obtained from all patients who meet the inclusion criteria and accept to participate in the trial.
Before starting the leveling and alignment procedures on the maxillary dental arch, skeletal anchorage will be secure on the maxillary dental arch using self-drilling mini-implants (1.6 * 8 mm; 3S screw, Hubit™, Seoul, Korea) that will apply between the roots of the maxillary first molars and the second premolars. The patients will be referred for maxillary first premolars extraction at the Department of Maxillofacial Surgery, Damascus University, Faculty of Dentistry.
This study will use fixed orthodontic appliances with an MBT prescription and a 0.022-inch bracket slot (VotionTM, Ortho Technology, Florida, USA). The two groups will follow a uniform wire sequence starting from a 0.014-inch NiTi wire until they reach the 0.019*0.025-inch stainless steel basic archwire, with a 3-week interval between each wire.
The sliding technique will be used for en-masse retraction in both study groups. An orthodontic force of approximately 500 g (250 g on each side) will be applied to the crimpable hooks using bilateral closed coil nickel titanium springs (NT3 closed coil springs, American Orthodontics, Sheboygan, Wisconsin) anchored to orthodontic mini-screws. Patients will be followed up every 2 weeks during this phase to adjust the springs to maintain a constant force. The endpoint of en-masse retraction in both groups will be determined when the maxillary canines achieve a Class I relationship with the mandible and a normal incisor relationship.
The removable electrical stimulation device utilized in the study by Shaadouh et al.. to provide the electrical stimulation will be used in this trial for the same purpose.
Each patient in the low-intensity electrical stimulation group will be asked to wear a removable device for five hours daily until the completion of the retraction of the upper anterior teeth.
To evaluate external apical root resorption (EARR), digital panoramic radiographs will be taken at three time points: before orthodontic treatment (T0), before en-masse retraction (T1), and after en-masse retraction (T2). The ImageJ software (NIH and LOCI, Madison, Wisconsin, USA) was used to analyze these radiographs. The method, originally described by Linge and Linge will be used to calculate the root resorption.
The gingival index (GI), the papillary bleeding index (PBI), and the dental plaque index (DPI) will be measured on the upper anterior teeth at the previous assessment times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electric stimulation with retraction | Experimental | Device: Electric stimulation removabel deviceElectric current will be applied in this group of patients using a removable device. |
| Traditional retraction | Active comparator | Procedure: Traditional retraction method.No acceleration method will be performed in this group. Only the traditional method of retraction will be followed. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- Healthy adult patients, Male and female, Age range: 18-25 years.
- Class II Division 1 malocclusion :
- Permanent occlusion.
- The Existence of all the upper teeth (except third molars).
- Good oral and periodontal health:
Key exclusion criteria (6 listed)
- Medical problems that affect tooth movement, such as corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs).
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm Radiographic evidence of bone loss Gingival index > 1 Plaque index > 1
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 |
|---|---|---|
| Electric stimulation removabel deviceThe device will be used to stimulate orthodontic tooth movement through a specific design used to deliver the current to the mucosa around the teeth being retracted. | Device | Electric stimulation with retraction |
| Traditional retraction method.In this intervention, the upper anterior teeth will be retracted together backward using the traditional retraction method. No acceleration devices will be used in conjunction with this procedure. | Procedure or surgery | Traditional retraction |
Primary outcome
Change in external apical root resorption
Time frame: The digital panoramic radiographs will be taken at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
The root length will be measured for each root of six upper anterior teeth. The method originally described by Linge and Linge will be used. The amount of root resorption (in millimeters) will be calculated using the following equation: Root Resorption = Root Length (T0) - (Root Length (T1) × Correction Factor). The Correction Factor will be calculated by dividing the crown Length (T0) to the crown Length (T1).
4 secondary outcomes
Change in the Gingival Index
Time frame: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Change in the Dental Plaque index
Time frame: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Change in the Bleeding Index
Time frame: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
Change in Gingival Recession
Time frame: Evaluation will be performed at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 6 months).
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 12 Mar 2025.
- Background: PubMed 37234453Shaadouh RI, Hajeer MY, Al-Sabbagh R, Alam MK, Mahmoud G, Idris G. A Novel Method to Accelerate Orthodontic Tooth Movement Using Low-Intensity Direct Electrical Current in Patients Requiring en-Masse Retraction of the Upper Anterior Teeth: A Preliminary Clinical Report. Cureus. 2023 May 24;15(5):e39438. doi: 10.7759/cureus.39438. eCollection 2023 May.
- Background: PubMed 6243448Davidovitch Z, Finkelson MD, Steigman S, Shanfeld JL, Montgomery PC, Korostoff E. Electric currents, bone remodeling, and orthodontic tooth movement. II. Increase in rate of tooth movement and periodontal cyclic nucleotide levels by combined force and electric current. Am J Orthod. 1980 Jan;77(1):33-47. doi: 10.1016/0002-9416(80)90222-5.
- Background: PubMed 26917494Spadari GS, Zaniboni E, Vedovello SA, Santamaria MP, do Amaral ME, Dos Santos GM, Esquisatto MA, Mendonca FA, Santamaria M Jr. Electrical stimulation enhances tissue reorganization during orthodontic tooth movement in rats. Clin Oral Investig. 2017 Jan;21(1):111-120. doi: 10.1007/s00784-016-1759-6. Epub 2016 Feb 26.
- Background: PubMed 39316889Shaadouh RI, Hajeer MY, Awawdeh MA, Jaber ST, Mahmoud GA, Almasri IA. Effectiveness of low-intensity electrical current in accelerating the en-masse retraction of the upper anterior teeth following first-premolar extraction in young adult patients with Class II division 1 malocclusion: A randomized controlled clinical trial. Int Orthod. 2024 Dec;22(4):100921. doi: 10.1016/j.ortho.2024.100921. Epub 2024 Sep 23.
- Derived from this study: PubMed 40762524Shaadouh RI, Hajeer MY, Alam MK, Jaber ST. Effect of Low-Intensity Electrical Stimulation on External Apical Root Resorption and Periodontal Indices Following En-Masse Retraction of Upper Anterior Teeth in Young Adults: A Randomized Controlled Trial. Clin Exp Dent Res. 2025 Aug;11(4):e70188. doi: 10.1002/cre2.70188.
- 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.
Rashad Ibrahem Shaadouh, DDS MSc principal investigator
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electric stimulation removabel device and Traditional retraction method. in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
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 12 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 12 Mar 2025. 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 Syria. 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?
Change in external apical root resorption (time frame: The digital panoramic radiographs will be taken at: (T1) one day before treatment commencement, (T2) at the end of the levelling stage (expected to occur within 3 - 4 months), (T3) one day after the end of retraction (expected to occur within 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 NCT06873490, which also lists 5 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 12 Mar 2025.