Crowding, ToothNCT05416242

Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets

A study testing Traditional braces, Self-ligating braces and Self-ligating braces + piezocision in people with Crowding, Tooth, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 28 years
Conditions the study is for: Crowding, Tooth
What is being tested?: Traditional braces, Self-ligating braces and Self-ligating braces + piezocision
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteSyria
Study dates: 14 Apr 2019to 22 Aug 2021
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 28 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The patient's age is between 18 and 25 years
Severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction
Little's Index of Irregularity is greater than 7 mm
Overbite ranging between 0-4 mm
Normal inclination of the upper incisors
No missing teeth (except for third molars)
Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0)

Who cannot join

The presence of any systemic disease affecting orthodontic movement
The presence of congenital syndromes or cleft lip and palate
Poor oral health with a plaque index greater than (1)
Skeletal maxillary constriction

Trial locations and contacts

1 site in 1 country.

Syria1 site

University of Damascus
Damascus

Other trials in Syria

About this study

Official title: Evaluation of Patient-centered Outcomes Associated With Acceleration of Lower Incisors Decrowding Using Self-ligating Brackets With and Without Piezocision in Comparison With Traditional Brackets: A Randomized Controlled Clinical Trial

The different types of brackets (e.g., self-ligating and conventional brackets), and the various acceleration methods (e.g., corticotomy) cause varying degrees of pain and discomfort. This study will assess pain, discomfort, and other patient-centered outcomes in adults with severe crowding on the upper jaw requiring two first premolars extraction.

There are three groups:

The first group (control group): the patients in this group will be treated using conventional brackets alone.

The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.

The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

Read the detailed description

Pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. The perception of pain is affected by many factors related to the patient, such as age, gender and any previous treatment experiences, which are negatively or positively reflected on the patient's cooperation. As for the factors related to the type of orthodontic treatment provided, the pain and discomfort are proportional to the brackets system used and the forces applied, especially in the leveling and alignment stage. The amount of tooth movement is directly affected by the friction between the brackets and the wires used. The physical properties of the wire and brackets used and the dimensions of the applied wires, in addition to the type of ligation play a significant role in the amount of friction generated.

Conditions: Crowding, Tooth
Being tested: Traditional braces, Self-ligating braces, Self-ligating braces + piezocision
Keywords: Self-Ligating Brackets, Flapless corticotomy, Severe crowding, Leveling, Aligning
Medical subject headings: Malocclusion, Crowding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Traditional bracesDevice
MBT 0.022 perception traditional braces will be used without any acceleration method.
Self-ligating bracesDevice
MBT 0.022 perception Self-ligating braces will be used without any acceleration method.
Self-ligating braces + piezocisionProcedure or surgery
Flapless corticotomy will be applied for the upper anterior teeth.

Study groups in NCT05416242
Study group	Role	What they receive
Fixed appliance	Active comparator	Patients in this group will be treated using traditional brackets alone. Receives: Device: Traditional braces
Self-ligaton appliance	Experimental	Patients in this group will be treated using self-ligating brackets alone. Receives: Device: Self-ligating braces
Self-ligaton appliance + piezocision	Experimental	Patients in this group will be treated using self-ligating brackets associated with piezocision. Receives: Procedure: Self-ligating braces + piezocision

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the levels of pain
Patients will be asked this question about their feeling of pain (Item no 01):
'What is the degree of pain you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours; 4 days; 7 days; 14 days; 28 days
Change in the levels of discomfort
Patients will be asked this question about their feeling of discomfort (Item no 02):
'What is the degree of discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours; 4 days; 7 days; 14 days; 28 days
Change in the Perception of swelling
Patients will be asked this question about their feeling of swelling (Item no 03):
'What is the degree of swelling you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours; 4 days; 7 days; 14 days; 28 days
Change in the difficulty of mastication
'What is the degree of mastication difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours; 4 days; 7 days; 14 days; 28 days
Change in the difficulty of swallowing
Patients will be asked this question about their feeling of swallowing (Item no 05):
'What is the degree of swallowing difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours; 4 days; 7 days; 14 days; 28 days
Change in the perception of the jaw movement restriction
Patients will be asked this question about their feeling of the jaw movement restriction (Item no 06):
'What is the degree of the jaw movement restriction you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours; 4 days; 7 days; 14 days; 28 days
The levels of satisfaction
Patients will be asked this question about their levels of satisfaction (Item no 07): 'What is your levels of satisfaction on the orthodontic treatment provided?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no satisfaction- 100: the highest satisfaction). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: This outcome will be assessed at 28 days following the beginning of treatment
Recommendation of the procedure to a friend
Patients will be asked this question (Item no 08): 'Would you recommend a friend undergo this treatment?' Assessment will be performed using a two-point scale to answer yes or no.
Measured: This outcome will be assessed at 28 days following the beginning of treatment
The possibility of repeating the procedure
Patients will be asked this question about the possibility of repeating the procedure (Item no 09): 'Would you accept to undergo this treatment again?' Assessment will be performed using a two-point scale to answer yes or no.
Measured: This outcome will be assessed at 28 days following the beginning of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 201922 Aug 2021

First posted13 Jun 2022
Study start14 Apr 2019
Primary completion7 Oct 2020
Study completion22 Aug 2021

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 Crowding, ToothStudies 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: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05416242
Sponsor's protocol ID: UDDS-Ortho-11-2022
Status last verified: Jun 2022
First submitted: 5 Jun 2022
Last updated: 14 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jahanbin A, Hasanzadeh N, Khaki S, Shafaee H. Comparison of self-ligating Damon3 and conventional MBT brackets regarding alignment efficiency and pain experience: A randomized clinical trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):281-288. doi: 10.15171/joddd.2019.043.
PubMed 32190212
Fleming PS, Dibiase AT, Sarri G, Lee RT. Pain experience during initial alignment with a self-ligating and a conventional fixed orthodontic appliance system. A randomized controlled clinical trial. Angle Orthod. 2009 Jan;79(1):46-50. doi: 10.2319/121007-579.1.
PubMed 19123718
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
PubMed 30991984
Lai TT, Chiou JY, Lai TC, Chen T, Wang HY, Li CH, Chen MH. Perceived pain for orthodontic patients with conventional brackets or self-ligating brackets over 1 month period: A single-center, randomized controlled clinical trial. J Formos Med Assoc. 2020 Jan;119(1 Pt 2):282-289. doi: 10.1016/j.jfma.2019.05.014. Epub 2019 Jun 14.
PubMed 31208826
Tecco S, D'Attilio M, Tete S, Festa F. Prevalence and type of pain during conventional and self-ligating orthodontic treatment. Eur J Orthod. 2009 Aug;31(4):380-4. doi: 10.1093/ejo/cjp003. Epub 2009 May 22.
PubMed 19465738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Not yet recruiting
Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment
Malaligned Teeth, Crowding of Teeth

All Crowding, Tooth trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Patient-centered Outcomes Associated With Acceleration of Lower Incisors Decrowding Using Self-ligating Brackets With and Without Piezocision in Comparison With Traditional Brackets: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT05416242
Acronym / sponsor ID: UDDS-Ortho-11-2022
Conditions: Crowding, Tooth
Keywords: Self-Ligating Brackets, Flapless corticotomy, Severe crowding, Leveling, Aligning
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 14 Apr 2019 (actual)
Primary completion: 7 Oct 2020 (actual)
Study completion: 22 Aug 2021 (actual)
First posted: 13 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

There are three groups:

The first group (control group): the patients in this group will be treated using conventional brackets alone.

The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone.

The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Fixed appliance	Active comparator	Device: Traditional bracesPatients in this group will be treated using traditional brackets alone.
Self-ligaton appliance	Experimental	Device: Self-ligating bracesPatients in this group will be treated using self-ligating brackets alone.
Self-ligaton appliance + piezocision	Experimental	Procedure: Self-ligating braces + piezocisionPatients in this group will be treated using self-ligating brackets associated with piezocision.

Who may qualify

Ages: 18 to 28 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

The patient's age is between 18 and 25 years
Severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction
Little's Index of Irregularity is greater than 7 mm
Overbite ranging between 0-4 mm
Normal inclination of the upper incisors

Key exclusion criteria (4 listed)

The presence of any systemic disease affecting orthodontic movement
The presence of congenital syndromes or cleft lip and palate
Poor oral health with a plaque index greater than (1)
Skeletal maxillary constriction

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
Traditional bracesMBT 0.022 perception traditional braces will be used without any acceleration method.	Device	Fixed appliance
Self-ligating bracesMBT 0.022 perception Self-ligating braces will be used without any acceleration method.	Device	Self-ligaton appliance
Self-ligating braces + piezocisionFlapless corticotomy will be applied for the upper anterior teeth.	Procedure or surgery	Self-ligaton appliance + piezocision

Primary outcome

Change in the levels of pain
Time frame: After 24 hours; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of pain (Item no 01): 'What is the degree of pain you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the levels of discomfort
Time frame: After 24 hours; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of discomfort (Item no 02): 'What is the degree of discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the Perception of swelling
Time frame: After 24 hours; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of swelling (Item no 03): 'What is the degree of swelling you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the difficulty of mastication
Time frame: After 24 hours; 4 days; 7 days; 14 days; 28 days
'What is the degree of mastication difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the difficulty of swallowing
Time frame: After 24 hours; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of swallowing (Item no 05): 'What is the degree of swallowing difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the perception of the jaw movement restriction
Time frame: After 24 hours; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of the jaw movement restriction (Item no 06): 'What is the degree of the jaw movement restriction you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
The levels of satisfaction
Time frame: This outcome will be assessed at 28 days following the beginning of treatment
Patients will be asked this question about their levels of satisfaction (Item no 07): 'What is your levels of satisfaction on the orthodontic treatment provided?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no satisfaction- 100: the highest satisfaction). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Recommendation of the procedure to a friend
Time frame: This outcome will be assessed at 28 days following the beginning of treatment
Patients will be asked this question (Item no 08): 'Would you recommend a friend undergo this treatment?' Assessment will be performed using a two-point scale to answer yes or no.
The possibility of repeating the procedure
Time frame: This outcome will be assessed at 28 days following the beginning of treatment
Patients will be asked this question about the possibility of repeating the procedure (Item no 09): 'Would you accept to undergo this treatment again?' Assessment will be performed using a two-point scale to answer yes or no.

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 14 Jun 2022.
Background: PubMed 32190212Jahanbin A, Hasanzadeh N, Khaki S, Shafaee H. Comparison of self-ligating Damon3 and conventional MBT brackets regarding alignment efficiency and pain experience: A randomized clinical trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):281-288. doi: 10.15171/joddd.2019.043.
Background: PubMed 19123718Fleming PS, Dibiase AT, Sarri G, Lee RT. Pain experience during initial alignment with a self-ligating and a conventional fixed orthodontic appliance system. A randomized controlled clinical trial. Angle Orthod. 2009 Jan;79(1):46-50. doi: 10.2319/121007-579.1.
Background: PubMed 30991984Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
Background: PubMed 31208826Lai TT, Chiou JY, Lai TC, Chen T, Wang HY, Li CH, Chen MH. Perceived pain for orthodontic patients with conventional brackets or self-ligating brackets over 1 month period: A single-center, randomized controlled clinical trial. J Formos Med Assoc. 2020 Jan;119(1 Pt 2):282-289. doi: 10.1016/j.jfma.2019.05.014. Epub 2019 Jun 14.
Background: PubMed 19465738Tecco S, D'Attilio M, Tete S, Festa F. Prevalence and type of pain during conventional and self-ligating orthodontic treatment. Eur J Orthod. 2009 Aug;31(4):380-4. doi: 10.1093/ejo/cjp003. Epub 2009 May 22.
Individual participant dataSharing planned: No

Related trials for Crowding, Tooth

Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
Dental Crowding, Dental Occlusion, Traumatic
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Not yet recruiting
Effect of Different Adhesive Systems on White Spot Lesions During Fixed Orthodontic Treatment
Malaligned Teeth, Crowding of Teeth

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.

Heba M Al-Ibrahim, DDS,MSc principal investigator

Department of orthodontics, Damascus University, Syria

Mohammad Y Hajeer, DDS,MSc,PhD study director

Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria.

Issam ِAlkhoury, DDS,MSc,PhD study director

Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, 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 Traditional braces, Self-ligating braces and Self-ligating braces + piezocision in people with Crowding, Tooth, 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 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 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 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 the levels of pain (time frame: After 24 hours; 4 days; 7 days; 14 days; 28 days). 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 NCT05416242, 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 14 Jun 2022.