MalocclusionmalocclusionNCT05684510
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
A study testing clear aligners and traditional treatment Fixed appliances with class II elastics. in people with Malocclusion and Class II Malocclusion, run by Hama University at 1 site in Syria.
Trial summary
Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. Read more about this study
- Who is it for?
- Ages 15 to 20 years
- Conditions the study is for
- Malocclusion, Class II Malocclusion
- What is being tested?
- clear aligners and traditional treatment Fixed appliances with class II elastics.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSyria
- Study dates
- 25 Aug 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - Patients with permanent occlusion at age 15-20 years.
- Patients with class II division I (half cusp or Less) with moderate overjet (2-4mm).
- Patients with normal or horizontal growth pattern.
- Mild crowding (_<2 mm) in maxillary and mandibular arch.
- Patient with satisfactory periodontal health and good oral hygiene
- No previous orthodontic treatment
- Comprehensive medical and dental history ruling out any systemic disease.
Who cannot join
- Patients with periodontal disease.
- Patients with vertical growth pattern.
- Patients with missing or extracted teeth except third molar.
- Patients with temporomandibular joint disorder.
- Patients with Skeletal open bite.
- Patients with poor oral and gingival health
- Patients with neuromuscular disorder.
- Patients with severe skeletal class II.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
FATIMA NASHTR, MSc contact
Syria1 site, 1 recruiting
- Recruiting
Hama University
Hama, Hama Governorate
Fadi Jnaid, 988499015, Drfadijnaid@gmail.com
FATIMA NASHTR, fatimahnashtar96@gmail.com
About this study
Official title: Evaluation of Efficacy of Clear Aligners in Correction of Class II Malocclusion Using Intermaxillary Elastics: A Randomized Controlled
Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.
There are two group:
- a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
- a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.
Read the detailed description
Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.
There are two group:
- a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
- a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics. phase Intervention/treatment Condition or disease Not applicable Other: clear aligners Technique with class ii elastics. Other: fixed multibracket appliances with class ii elastics Malocclusion
Class ii Division 1 malocclusion
- Conditions
- Malocclusion, Class II Malocclusion
- Being tested
- clear aligners, traditional treatment Fixed appliances with class II elastics.
- Medical subject headings
- Malocclusion, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear alignersDevice
clear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar
traditional treatment Fixed appliances with class II elastics.Device
Agroup of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : clear aligners with class II elastics technique | Experimental | clear aligners technique A group of patients in which participants will be undergo to clear aligners treatment with class II elastics ( clear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar Receives: Device: clear aligners |
| : traditional treatment Fixed appliances with class II elastics. | Experimental | A group of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed. Receives: Device: traditional treatment Fixed appliances with class II elastics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the SNA angle
This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group
change in the SNB angle
This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved(expected to be within 4-6 months in the exp. Group and 12 months in the control group)
change in ANB angle
This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
change in SN.POG angle
This angle the represents the position of the chin bone in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
change in the mandibular length [
Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: T0: 1day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
change in SN.PP angle [
This angle the represents the amount and direction of rotation of the upper jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
change in MP.SN angle
This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Measured: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
change in overjet
Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis.
Measured: : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
change in overbite
Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis.
Measured: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start25 Aug 2026 (estimated)
- Primary completion11 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hama University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FADI JNAID, Hama University
- Investigators
- FATIMA NASHTR, MSc, Principal investigator, Hama UniversityRabab AlSabbag, Professor, Study director, Hama University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684510
- Sponsor's protocol ID
- Hama University -
- Acronym
- malocclusion
- Status last verified
- Sep 2025
- First submitted
- 5 Jan 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Clear Aligners in Correction of Class II Malocclusion Using Intermaxillary Elastics: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT05684510
- Acronym / sponsor ID
- malocclusion / Hama University -
- Conditions
- Malocclusion, Class II Malocclusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Hama UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Jan 2023 (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.
Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.
There are two group:
- a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
- a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.
Detailed description
Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances.
There are two group:
- a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
- a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics. phase Intervention/treatment Condition or disease Not applicable Other: clear aligners Technique with class ii elastics. Other: fixed multibracket appliances with class ii elastics Malocclusion
Class ii Division 1 malocclusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : clear aligners with class II elastics technique | Experimental | Device: clear alignersclear aligners technique A group of patients in which participants will be undergo to clear aligners treatment with class II elastics ( clear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar |
| : traditional treatment Fixed appliances with class II elastics. | Experimental | Device: traditional treatment Fixed appliances with class II elastics.A group of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed. |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- - Patients with permanent occlusion at age 15-20 years.
- Patients with class II division I (half cusp or Less) with moderate overjet (2-4mm).
- Patients with normal or horizontal growth pattern.
- Mild crowding (_<2 mm) in maxillary and mandibular arch.
- Patient with satisfactory periodontal health and good oral hygiene
Key exclusion criteria (8 listed)
- Patients with periodontal disease.
- Patients with vertical growth pattern.
- Patients with missing or extracted teeth except third molar.
- Patients with temporomandibular joint disorder.
- Patients with Skeletal open bite.
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 |
|---|---|---|
| clear alignersclear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar | Device | Experimental : clear aligners with class II elastics technique |
| traditional treatment Fixed appliances with class II elastics.Agroup of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed. | Device | : traditional treatment Fixed appliances with class II elastics. |
Primary outcome
Change in the SNA angle
Time frame: : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group
This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in the SNB angle
Time frame: : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved(expected to be within 4-6 months in the exp. Group and 12 months in the control group)
This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in ANB angle
Time frame: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in SN.POG angle
Time frame: : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
This angle the represents the position of the chin bone in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in the mandibular length [
Time frame: T0: 1day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in SN.PP angle [
Time frame: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
This angle the represents the amount and direction of rotation of the upper jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in MP.SN angle
Time frame: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
change in overjet
Time frame: : T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis.
change in overbite
Time frame: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- 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.
FATIMA NASHTR, MSc contact
FATIMA NASHTR, MSc principal investigator
Hama University
Rabab AlSabbag, Professor study director
Hama University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clear aligners and traditional treatment Fixed appliances with class II elastics. in people with Malocclusion and Class II Malocclusion, run by Hama 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 8 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fadi Jnaid (988499015, Drfadijnaid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the SNA angle (time frame: : T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group). 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?
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 16 Sep 2026.