Malocclusion, Angle Class II, Division 1NCT03399422
Efficacy of Biological Technique in Upper Canine Retraction and Levels of Discomfort
A study testing i-PRF and canine retraction in people with Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.
Trial summary
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region , and the other side served as the control. Read more about this study
- Who is it for?
- Ages 15 to 27 years
- Conditions the study is for
- Malocclusion, Angle Class II, Division 1
- What is being tested?
- i-PRF and canine retraction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSyria
- Study dates
- 20 Aug 2017to 1 Aug 2019
- 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 15 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult healthy patients, Male and female, Age range: 15-27 years.
- Class II Division 1 malocclusion:
- Mild / moderate skeletal Class II (ANB ≤7) Overjet ≤10 Normal or excessive facial height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y axis) Mild to moderate crowding ≤ 4
- permanent occlusion.
- Exist 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 (corticosteroid, NSAIDs, …)
- patients have anti indication for oral surgery ( medical - social - psycho)
- 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
Show all 11Show fewer
- Patient had previous orthodontic treatment
- Craniofacial anomalies (cleft lip and palate patients)
- Smokers
- coagulation disorders and patients treated with anticoagulants.
- patients with immunodeficiency disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Upper Canine Retraction and the Levels of Acceptance and Discomfort
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region , and the other side served as the control. canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side , soldered transpalatal arch will be used as an anchor unit.
Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, over a follow-up period until a Class I canine relationship will be achieved. The levels of Pain and discomfort will be monitored using a questionnaire with a VAS scale administered three times during the first day after prf injection.
Read the detailed description
Reduced orthodontic treatment duration is important for care providers and orthodontic patients.it is also desirable that aesthetic concerns and time dependent adverse events such as discomfort, pain, external root resorption, suboptimal oral hygiene, white spot lesions and dental caries are held to the minimum. Although the surgical assisted accelerated orthodontic tooth movement (such as distraction of periodontal ligament, distraction of dentoalveolus, periodontally accelerated osteogenic orthodontics (PAOO),Corticision, orthognathic surgery, piezocision, piezopuncture and micro osteoperforation). It has been proved to be the most effective one currently, its disadvantages are: it is a bone surgery, and it causes loss of alveolar bone that undermines the periodontal support of the target teeth.
Noninvasive and nonsurgical methods have always been preferred by both the clinicians and the patients. These techniques have ranged from application of biological molecules to innovative technologies such as resonance vibration, cyclic forces, light electrical currents, magnetic field forces, low-intensity laser irradiation and low-level light therapy. Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing.
That's why the submucosal injection of platelet rich plasma (PRP) is a technique developed for accelerating orthodontic tooth movement by simulating the effects of bone insult without surgery and loss of alveolar bone, Some researchers found that prp injection created a regional acceleratory phenomenon-like effect which forms the basis of rapid tooth movement compared with conventional orthodontic treatment.
From here it has been thought about using a method to eliminate the surgical techniques' side effects. It has been found that platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
PRF characteristics in comparison to platelet rich plasma PRP are:
- its preparation is completely natural and there is no need for thrombin addition so there isn't immune reaction
- it contains stem cells
- it requires one stage centrifugation
- PRF has been reported to gradually release autologous growth factors and expressed stronger and more durable effect on the cellular proliferation and differentiation than PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic treatment, because of its benefits and easiness of using in dental clinic Study sample that consists of 20 patients, was calculated using (G-power sample size calculator), depending on the rate of canine retraction with a study power of 95%.
Allocation of the sides of intervention (PRF injection) and control sides is made by computer program (Excel).
After ensuring of the patients compliance with the terms and conditions of this study, the purpose and methods of the study will be explained to the patients using Information Sheet. In case of approval to participate, the patients asked to sign the Informed Consent.
Extra \& Intra-oral photographs, impressions and clinical examination will be made.
Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time 20ml of patients' blood will be withdrawn and centrifuged (700 rpm within 3 minutes) to get 4ml i-PRF. PRF will be injected at the area of the extracted first premolar, The first point place is in the buccal interventional side (supra periosteal injection) and the second point place is in the palatal interventional side(sub periosteal injection). PRF will be injected twice at the beginning and at the middle of the canine retraction.
All measures will be analyzed before and after canine retraction between two sides.
A questionnaire will be given to the patients to study pain level accompanying PRF injection compared to the control side. Pain will be assessed using Visual Analogue Scale (VAS) 1 (No Pain) - 10 (Worst Pain).
A questionnaire will be given to the patients to study their acceptance of new treatment approach with comprehensive orthodontic treatments.
- Conditions
- Malocclusion, Angle Class II, Division 1
- Being tested
- i-PRF, canine retraction
- Keywords
- i-PRF (injectable platelet rich fibrin), canine retraction, pain and discomfort
- Medical subject headings
- Malocclusion, Angle Class II, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-PRFBiological
i-PRF (injectable platelet rich fibrin) assisted upper canine retraction
canine retractionProcedure or surgery
upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
| Study group | Role | What they receive |
|---|---|---|
| i-PRF assisted upper canine retraction | Experimental | I-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars Receives: Biological: i-PRF; Procedure: canine retraction |
| conventional upper canine retraction | Experimental | Conventional upper canine retraction will be performed in the other side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars Receives: Procedure: canine retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the rate of canine retraction
The rate of canine retraction defines as the distance traveled in millimeters (mm) divided by the time required (in week).
Orthodontic models will be taken before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1).
The distance of canine retraction will be calculated by measuring the difference between the initial cast and the final cast using the method described by Ziegler and Ingervall, which rely on Stable palatal reference Points (the medial ends of the third palatal rugae, Midpalatal Suture) and the tips of the canines and then this distance will be divided by the number of intervals (weeks) to give the rate of retraction in millimeters per week.
Measurements will be made from the orthodontic models manually by direct technique using digital dental calipers.
Measured: Before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1) which will be approximately after 6 months from the beginning of canine retraction
Secondary outcomes (1)
pain levels
A questionnaire will be given to the patients to study pain level accompanying PRF injection compared to the control side.
Pain will be assessed using Visual Analogue Scale (VAS) 1 (No Pain) - 10 (Worst Pain)
Measured: on the first day after an hour, 2 hours and 6 hours of PRF injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start20 Aug 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class II, Division 1Studies 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
- Crossover
- Model description
- Two Arms injectable platelet rich fibrin group: consisted of two subgroups Experimental group : injectable platelet rich fibrin assisted upper canine retraction Control group: conventional upper canine retraction
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rania Haddad, PhD., Study director, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399422
- Sponsor's protocol ID
- UDDS-Ortho-02-2018
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
Publications
Rosvall MD, Fields HW, Ziuchkovski J, Rosenstiel SF, Johnston WM. Attractiveness, acceptability, and value of orthodontic appliances. Am J Orthod Dentofacial Orthop. 2009 Mar;135(3):276.e1-12; discussion 276-7. doi: 10.1016/j.ajodo.2008.09.020.
PubMed 19268820Almpani K, Kantarci A. Nonsurgical Methods for the Acceleration of the Orthodontic Tooth Movement. Front Oral Biol. 2016;18:80-91. doi: 10.1159/000382048. Epub 2015 Nov 24.
PubMed 26599121Gulec A, Bakkalbasi BC, Cumbul A, Uslu U, Alev B, Yarat A. Effects of local platelet-rich plasma injection on the rate of orthodontic tooth movement in a rat model: A histomorphometric study. Am J Orthod Dentofacial Orthop. 2017 Jan;151(1):92-104. doi: 10.1016/j.ajodo.2016.05.016.
PubMed 28024792Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
PubMed 19089687Naik B, Karunakar P, Jayadev M, Marshal VR. Role of Platelet rich fibrin in wound healing: A critical review. J Conserv Dent. 2013 Jul;16(4):284-93. doi: 10.4103/0972-0707.114344.
PubMed 23956527Ziegler P, Ingervall B. A clinical study of maxillary canine retraction with a retraction spring and with sliding mechanics. Am J Orthod Dentofacial Orthop. 1989 Feb;95(2):99-106. doi: 10.1016/0889-5406(89)90388-0.
PubMed 2916474Zeitounlouian T, Haddad R, Brad B, Ballouk MA, Fudalej P. Does the application of autologous injectable Platelet-Rich Fibrin (i-PRF) affect the patient's daily performance during the retraction of upper canines? A single-centre randomized split-mouth controlled trial. BMC Oral Health. 2023 Nov 17;23(1):872. doi: 10.1186/s12903-023-03646-z.
PubMed 37978474
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Efficacy of Injectable Platelet Rich Fibrin (i-PRF) in Upper Canine Retraction and the Levels of Acceptance and Discomfort
- ClinicalTrials.gov ID
- NCT03399422
- Acronym / sponsor ID
- UDDS-Ortho-02-2018
- Conditions
- Malocclusion, Angle Class II, Division 1
- Keywords
- i-PRF (injectable platelet rich fibrin), canine retraction, pain and discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 16 Jan 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.
Twenty patients need therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines, will be divided randomly into two groups, and will randomly assigned to one side of the maxillary arch at the first premolar region , and the other side served as the control. canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side , soldered transpalatal arch will be used as an anchor unit.
Pre- and post distalization dental casts will be evaluated to study rate of canine distalization, over a follow-up period until a Class I canine relationship will be achieved. The levels of Pain and discomfort will be monitored using a questionnaire with a VAS scale administered three times during the first day after prf injection.
Detailed description
Reduced orthodontic treatment duration is important for care providers and orthodontic patients.it is also desirable that aesthetic concerns and time dependent adverse events such as discomfort, pain, external root resorption, suboptimal oral hygiene, white spot lesions and dental caries are held to the minimum. Although the surgical assisted accelerated orthodontic tooth movement (such as distraction of periodontal ligament, distraction of dentoalveolus, periodontally accelerated osteogenic orthodontics (PAOO),Corticision, orthognathic surgery, piezocision, piezopuncture and micro osteoperforation). It has been proved to be the most effective one currently, its disadvantages are: it is a bone surgery, and it causes loss of alveolar bone that undermines the periodontal support of the target teeth.
Noninvasive and nonsurgical methods have always been preferred by both the clinicians and the patients. These techniques have ranged from application of biological molecules to innovative technologies such as resonance vibration, cyclic forces, light electrical currents, magnetic field forces, low-intensity laser irradiation and low-level light therapy. Endogenously produced biologicals have been tested based on their roles in the turnover of alveolar bone in response to orthodontic tooth movement as well as during wound healing.
That's why the submucosal injection of platelet rich plasma (PRP) is a technique developed for accelerating orthodontic tooth movement by simulating the effects of bone insult without surgery and loss of alveolar bone, Some researchers found that prp injection created a regional acceleratory phenomenon-like effect which forms the basis of rapid tooth movement compared with conventional orthodontic treatment.
From here it has been thought about using a method to eliminate the surgical techniques' side effects. It has been found that platelet rich fibrin (PRF) has the ability to enhance tissue regeneration, accelerate wound healing and inducing stem cells differentiation through its growth factors (GFs).
PRF characteristics in comparison to platelet rich plasma PRP are:
- its preparation is completely natural and there is no need for thrombin addition so there isn't immune reaction
- it contains stem cells
- it requires one stage centrifugation
- PRF has been reported to gradually release autologous growth factors and expressed stronger and more durable effect on the cellular proliferation and differentiation than PRP in vitro This is the first study in the world that will use i-PRF with Orthodontic treatment, because of its benefits and easiness of using in dental clinic Study sample that consists of 20 patients, was calculated using (G-power sample size calculator), depending on the rate of canine retraction with a study power of 95%.
Allocation of the sides of intervention (PRF injection) and control sides is made by computer program (Excel).
After ensuring of the patients compliance with the terms and conditions of this study, the purpose and methods of the study will be explained to the patients using Information Sheet. In case of approval to participate, the patients asked to sign the Informed Consent.
Extra \& Intra-oral photographs, impressions and clinical examination will be made.
Canine retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side at the same time 20ml of patients' blood will be withdrawn and centrifuged (700 rpm within 3 minutes) to get 4ml i-PRF. PRF will be injected at the area of the extracted first premolar, The first point place is in the buccal interventional side (supra periosteal injection) and the second point place is in the palatal interventional side(sub periosteal injection). PRF will be injected twice at the beginning and at the middle of the canine retraction.
All measures will be analyzed before and after canine retraction between two sides.
A questionnaire will be given to the patients to study pain level accompanying PRF injection compared to the control side. Pain will be assessed using Visual Analogue Scale (VAS) 1 (No Pain) - 10 (Worst Pain).
A questionnaire will be given to the patients to study their acceptance of new treatment approach with comprehensive orthodontic treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two Arms injectable platelet rich fibrin group: consisted of two subgroups Experimental group : injectable platelet rich fibrin assisted upper canine retraction Control group: conventional upper canine retraction
| Arm | Type | Receives |
|---|---|---|
| i-PRF assisted upper canine retraction | Experimental | Biological: i-PRF, Procedure: canine retractionI-PRF assisted upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars |
| conventional upper canine retraction | Experimental | Procedure: canine retractionConventional upper canine retraction will be performed in the other side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars |
Who may qualify
- Ages
- 15 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Adult healthy patients, Male and female, Age range: 15-27 years.
- Class II Division 1 malocclusion:
- Mild / moderate skeletal Class II (ANB ≤7) Overjet ≤10 Normal or excessive facial height (Clinically and then cephalometry assessed using these angles : SN-MP , MM , Y axis) Mild to moderate crowding ≤ 4
- permanent occlusion.
- Exist all the upper teeth (except third molars).
Key exclusion criteria (11 listed)
- Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
- patients have anti indication for oral surgery ( medical - social - psycho)
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal 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 |
|---|---|---|
| i-PRFi-PRF (injectable platelet rich fibrin) assisted upper canine retraction | Biological | i-PRF assisted upper canine retraction |
| canine retractionupper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars | Procedure or surgery | conventional upper canine retraction, i-PRF assisted upper canine retraction |
Primary outcome
Change of the rate of canine retraction
Time frame: Before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1) which will be approximately after 6 months from the beginning of canine retraction
The rate of canine retraction defines as the distance traveled in millimeters (mm) divided by the time required (in week). Orthodontic models will be taken before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1). The distance of canine retraction will be calculated by measuring the difference between the initial cast and the final cast using the method described by Ziegler and Ingervall, which rely on Stable palatal reference Points (the medial ends of the third palatal rugae, Midpalatal Suture) and the tips of the canines and then this distance will be divided by the number of intervals (weeks) to give the rate of retraction in millimeters per week. Measurements will be made from the orthodontic models manually by direct technique using digital dental calipers.
1 secondary outcome
pain levels
Time frame: on the first day after an hour, 2 hours and 6 hours of PRF injection
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 5 Feb 2020.
- Background: PubMed 19268820Rosvall MD, Fields HW, Ziuchkovski J, Rosenstiel SF, Johnston WM. Attractiveness, acceptability, and value of orthodontic appliances. Am J Orthod Dentofacial Orthop. 2009 Mar;135(3):276.e1-12; discussion 276-7. doi: 10.1016/j.ajodo.2008.09.020.
- Background: PubMed 26599121Almpani K, Kantarci A. Nonsurgical Methods for the Acceleration of the Orthodontic Tooth Movement. Front Oral Biol. 2016;18:80-91. doi: 10.1159/000382048. Epub 2015 Nov 24.
- Background: PubMed 28024792Gulec A, Bakkalbasi BC, Cumbul A, Uslu U, Alev B, Yarat A. Effects of local platelet-rich plasma injection on the rate of orthodontic tooth movement in a rat model: A histomorphometric study. Am J Orthod Dentofacial Orthop. 2017 Jan;151(1):92-104. doi: 10.1016/j.ajodo.2016.05.016.
- Background: PubMed 19089687Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
- Background: PubMed 23956527Naik B, Karunakar P, Jayadev M, Marshal VR. Role of Platelet rich fibrin in wound healing: A critical review. J Conserv Dent. 2013 Jul;16(4):284-93. doi: 10.4103/0972-0707.114344.
- Background: PubMed 2916474Ziegler P, Ingervall B. A clinical study of maxillary canine retraction with a retraction spring and with sliding mechanics. Am J Orthod Dentofacial Orthop. 1989 Feb;95(2):99-106. doi: 10.1016/0889-5406(89)90388-0.
- Derived from this study: PubMed 37978474Zeitounlouian T, Haddad R, Brad B, Ballouk MA, Fudalej P. Does the application of autologous injectable Platelet-Rich Fibrin (i-PRF) affect the patient's daily performance during the retraction of upper canines? A single-centre randomized split-mouth controlled trial. BMC Oral Health. 2023 Nov 17;23(1):872. doi: 10.1186/s12903-023-03646-z.
- Individual participant dataSharing planned: No. The Individual participant data will be only available for the researchers in the department of Orthodontics, Damascus University
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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.
Rania Haddad, PhD. study director
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 i-PRF and canine retraction in people with Malocclusion, Angle Class II, Division 1, 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 7 inclusion and 11 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 5 Feb 2020. 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 of the rate of canine retraction (time frame: Before the beginning of canine retraction and every 28 days until the canines will be in the proper position (class 1) which will be approximately after 6 months from the beginning of canine retraction). 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 NCT03399422, which also lists 7 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 5 Feb 2020.