Class II MalocclusionNCT05656898

Evaluation of the Levels of Pain and Discomfort and Periodontal Status Between Two Acceleration Methods of Upper Anterior Teeth Retraction

A study testing Piezocision+GaALAs diode laser, Piezocision and Orthodontic fixed appliance in people with Class II Malocclusion, 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 17 to 28 years
Conditions the study is for: Class II Malocclusion
What is being tested?: Piezocision+GaALAs diode laser, Piezocision and Orthodontic fixed appliance
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSyria
Study dates: 9 Feb 2021to 15 May 2023
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 17 to 28 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Adult healthy patients, Male and female, Age range: 17-28 years.
Class II Division 1 malocclusion :
Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7)
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)
Mild to moderate crowding ≤ 4

Show all 13Show fewer

Permanent occlusion.
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 (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

Show all 9Show fewer

Gingival index > 1
Plaque index > 1
The patient had previous orthodontic treatment

Trial locations and contacts

1 site in 1 country.

Syria1 site

University of Damascus
Damascus

Other trials in Syria

About this study

Official title: Comparison Between the Flapless Corticotomy Enhanced by the Later Application of Low-intensity Laser Therapy on Patient-centred Outcomes and Periodontal Health in Patients Undergoing en Masse Retraction of Upper Anterior Teeth

60 patients will be treated by extraction of maxillary first premolars by applying mini-screws between the maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). They will be divided randomly into three groups in this trial. The prolonged duration of the treatment period can cause many side effects such as white spots, caries, periodontal diseases, and pain and discomfort. So many efforts have been made to reduce the treatment time. Many procedures have been introduced to accelerate orthodontic tooth movement, which can category as surgical or non-surgical. Piezocision is a minimally invasive surgical method for accelerating orthodontic tooth movement and shortening treatment time. Low-level laser therapy (LLLT) is one of the physical acceleration methods that have contributed to decreasing treatment time.

Read the detailed description

Closed nickel-titanium coil springs applying 250 g of force per side will be used for retraction of the maxillary anterior teeth.

The en-masse retraction will be obtained with two nickel-titanium coil springs placed between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane, a force of 250 g will be applied on each side to perform en-masse retraction. The retraction will be stopped when a Class I canine relation is achieved and a good incisor relation is obtained or spaces lateral to canines are closed.

Regarding the Piezocision, vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars. The incisions will be 5 mm long and start 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8 mm in length. No suturing will be needed.

Regarding the piezocision with the later application of low-level laser therapy (LLLT):

After seven weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) 10 seconds per point will be applied on each tooth of the six maxillary anterior teeth according to this protocol: the root will be divided theoretically into 2 halves; gingival and cervical, and the laser will be applied in the centre of each half from both buccal and palatal sides which means 4 application points and total energy of 16 Joules per tooth. The LLLT will be applied 5 times in the first month of en masse retraction. After that, the irradiation will be repeated every two weeks, until the class, I canine relationship will be achieved and/or spaces lateral to incisors were closed

Conditions: Class II Malocclusion
Being tested: Piezocision+GaALAs diode laser, Piezocision, Orthodontic fixed appliance
Medical subject headings: Overbite

What participants receive

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

Piezocision+GaALAs diode laserDevice
After seven weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) 10 seconds per point will be applied on each tooth of the six maxillary anterior teeth .
PiezocisionDevice
Vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars.
Orthodontic fixed applianceDevice
Closed nickel-titanium coil springs applying 250 g of force per side will be used for retraction of the maxillary anterior teeth.

Study groups in NCT05656898
Study group	Role	What they receive
Piezosurgery pulse Low-level laser therapy	Experimental	Piezocision will be applied in this group of patients using a piezosurgery knife and after 6 weeks of initial retraction, low-level laser therapy will be applied in this group of patients using a diode laser device. Receives: Device: Piezocision+GaALAs diode laser
Piezosurgery	Experimental	Piezocision will be applied in this group of patients using a piezosurgery knife. Receives: Device: Piezocision
Traditional treatment	Active comparator	En masse retraction in this group will be performed in a conventional method. Receives: Device: Orthodontic fixed appliance

What is being measured

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

Change in the levels of pain during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of pain during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of discomfort during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of discomfort during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of swelling during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of swelling during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of eating difficulty during the first month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of eating difficulty during the third month of treatment assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Change in the levels of satisfaction assessed by the VAS
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Measured: These levels will be assessed only at day 14 of month 3 following the commencement of the retraction.
Recommendation of the procedure to a friend
Patients are asked if they would recommend the procedure to a friend. This question is going to be answered by "Yes" or "No", i.e., dichotomous scale.
Measured: This question is going to be posed only at day 14 of month 3 following the commencement of the retraction.

Timeline

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

9 Feb 202115 May 2023

First posted19 Dec 2022
Study start9 Feb 2021
Primary completion2 Dec 2022
Study completion15 May 2023

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 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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05656898
Sponsor's protocol ID: UDDS-Ortho-16-2021
Status last verified: Sep 2023
First submitted: 7 Dec 2022
Last updated: 29 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.
PubMed 32909702
Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038.
PubMed 35796046
Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
PubMed 27129491
Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
PubMed 24326120
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

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

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
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Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
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Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
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Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
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Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
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All Class II Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between the Flapless Corticotomy Enhanced by the Later Application of Low-intensity Laser Therapy on Patient-centred Outcomes and Periodontal Health in Patients Undergoing en Masse Retraction of Upper Anterior Teeth
ClinicalTrials.gov ID: NCT05656898
Acronym / sponsor ID: UDDS-Ortho-16-2021
Conditions: Class II Malocclusion
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 9 Feb 2021 (actual)
Primary completion: 2 Dec 2022 (actual)
Study completion: 15 May 2023 (actual)
First posted: 19 Dec 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.

Detailed description

Closed nickel-titanium coil springs applying 250 g of force per side will be used for retraction of the maxillary anterior teeth.

Regarding the piezocision with the later application of low-level laser therapy (LLLT):

Study design

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

Arm	Type	Receives
Piezosurgery pulse Low-level laser therapy	Experimental	Device: Piezocision+GaALAs diode laserPiezocision will be applied in this group of patients using a piezosurgery knife and after 6 weeks of initial retraction, low-level laser therapy will be applied in this group of patients using a diode laser device.
Piezosurgery	Experimental	Device: PiezocisionPiezocision will be applied in this group of patients using a piezosurgery knife.
Traditional treatment	Active comparator	Device: Orthodontic fixed applianceEn masse retraction in this group will be performed in a conventional method.

Who may qualify

Ages: 17 to 28 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (13 listed)

Adult healthy patients, Male and female, Age range: 17-28 years.
Class II Division 1 malocclusion :
Permanent occlusion.
Existence of all the upper teeth (except third molars).
Good oral and periodontal health:

Key exclusion criteria (9 listed)

Medical problems that affect tooth movement (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:
The patient had previous orthodontic treatment

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
Piezocision+GaALAs diode laserAfter seven weeks of piezosurgery, GaALAs diode laser (wavelength: 810 nm and exposure time of 10 seconds\point) 10 seconds per point will be applied on each tooth of the six maxillary anterior teeth .	Device	Piezosurgery pulse Low-level laser therapy
PiezocisionVertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars.	Device	Piezosurgery
Orthodontic fixed applianceClosed nickel-titanium coil springs applying 250 g of force per side will be used for retraction of the maxillary anterior teeth.	Device	Traditional treatment

Primary outcome

Change in the levels of pain during the first month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of pain during the third month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog Scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of discomfort during the first month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of discomfort during the third month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of swelling during the first month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of swelling during the third month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of eating difficulty during the first month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of eating difficulty during the third month of treatment assessed by the VAS
Time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Change in the levels of satisfaction assessed by the VAS
Time frame: These levels will be assessed only at day 14 of month 3 following the commencement of the retraction.
Assessment will be performed using questionnaires via the Visual Analog scale (VAS). The Visual Analog Scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no pain - 100: the worst pain).
Recommendation of the procedure to a friend
Time frame: This question is going to be posed only at day 14 of month 3 following the commencement of the retraction.
Patients are asked if they would recommend the procedure to a friend. This question is going to be answered by "Yes" or "No", i.e., dichotomous scale.

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 29 Sep 2023.
Background: PubMed 32909702Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.
Background: PubMed 35796046Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038.
Background: PubMed 27129491Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
Background: PubMed 24326120Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
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.
Individual participant dataSharing planned: No

Related trials for Class II Malocclusion

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children

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.

Mudar Mohammad Mousa, DDS principal investigator

Department of orthodontics, Damascus University, Syria

Mohammad Y. Hajeer, DDS,MSc,PhD study director

Department of orthodontics, Damascus University, 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 Piezocision+GaALAs diode laser, Piezocision and Orthodontic fixed appliance in people with Class II 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 13 inclusion and 9 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 29 Sep 2023. 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 during the first month of treatment assessed by the VAS (time frame: Time 1: 12 hours, Time 2: Day 1, Time 3: Day 3, Time 4: Day 7, Time 5: Day 14, following the commencement of the retraction.). The study lists 10 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 NCT05656898, 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 29 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.