Skeletal Class I Non-extraction Patients With Dental CrowdingNCT07090746
Evaluation of Dentoalveolar Changes of Clear Aligners Versus Fixed Orthodontic Appliances on Skeletal Class I Non-extraction Patients With Dental Crowding
A study testing Clear aligner and Fixed orthodontic appliance in people with Skeletal Class I Non-extraction Patients With Dental Crowding, run by Mansoura University at 1 site in Egypt.
Trial summary
To evaluate dentoalveolar changes of clear aligners versus fixed orthodontic appliances on skeletal class I non-extraction patients with dental crowding. Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Skeletal Class I Non-extraction Patients With Dental Crowding
- What is being tested?
- Clear aligner and Fixed orthodontic appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2023to Jan 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 18 to 22 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Complete permanent dentition.
- Angle Class I malocclusion cases with mild to moderate crowding (2-6 mm) that can be resolved by dental expansion and interproximal reduction (IPR).
- Good oral hygiene.
Who cannot join
- Bad oral hygiene.
- Previous orthodontic treatment.
- Periodontal disease and previous periodontal surgery procedures.
- Systemic diseases and/or craniofacial syndromes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dentoalveolar Changes of Clear Aligners Versus Fixed Orthodontic Appliances on Skeletal Class I Non-extraction Patients With Dental Crowding: Randomized Controlled Clinical Trial
To evaluate dentoalveolar changes of clear aligners versus fixed orthodontic appliances on skeletal class I non-extraction patients with dental crowding.
- Being tested
- Clear aligner, Fixed orthodontic appliance
- Keywords
- clear aligners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear alignerDevice
Clear aligner
Fixed orthodontic applianceDevice
Fixed orthodontic appliance
| Study group | Role | What they receive |
|---|---|---|
| Non extraction crowding cases for clear aligner | Active comparator | Not described Receives: Device: Clear aligner |
| Non extraction crowding cases for fixed orthodontic appliance | Active comparator | Not described Receives: Device: Fixed orthodontic appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar bone thickness
Alveolar bone thickness will be assessed in vestibular and oral sides, parallel to the cervical reference line (CRL) at 3 different evels and expressed in millimeters.
Measured: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
Alveolar bone height
Alveolar bone height loss will be measured perpendicularly to the CRL in both vestibular and oral sides. It will be represented as the difference between pretreatment and post treatment distance from alveolar crest to the CRL, expressed in millimeters.
Measured: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
Secondary outcomes (2)
Comparison of transverse dental changes between the two groups.
Assessment of inter-molar and inter-canine widths
Measured: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
Assessment of Apical root resorption
comparison of root length changes after treatment
Measured: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Dec 2023
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Class I Non-extraction Patients With Dental CrowdingStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kholod Elbady, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090746
- Sponsor's protocol ID
- A0208023OR
- Status last verified
- Jul 2025
- First submitted
- 2 Jun 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dentoalveolar Changes of Clear Aligners Versus Fixed Orthodontic Appliances on Skeletal Class I Non-extraction Patients With Dental Crowding: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07090746
- Acronym / sponsor ID
- A0208023OR
- Keywords
- clear aligners
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Dec 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate dentoalveolar changes of clear aligners versus fixed orthodontic appliances on skeletal class I non-extraction patients with dental crowding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non extraction crowding cases for clear aligner | Active comparator | Device: Clear aligner |
| Non extraction crowding cases for fixed orthodontic appliance | Active comparator | Device: Fixed orthodontic appliance |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Complete permanent dentition.
- Angle Class I malocclusion cases with mild to moderate crowding (2-6 mm) that can be resolved by dental expansion and interproximal reduction (IPR).
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Bad oral hygiene.
- Previous orthodontic treatment.
- Periodontal disease and previous periodontal surgery procedures.
- Systemic diseases and/or craniofacial syndromes.
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 alignerClear aligner | Device | Non extraction crowding cases for clear aligner |
| Fixed orthodontic applianceFixed orthodontic appliance | Device | Non extraction crowding cases for fixed orthodontic appliance |
Primary outcome
Alveolar bone thickness
Time frame: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
Alveolar bone thickness will be assessed in vestibular and oral sides, parallel to the cervical reference line (CRL) at 3 different evels and expressed in millimeters.
Alveolar bone height
Time frame: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
Alveolar bone height loss will be measured perpendicularly to the CRL in both vestibular and oral sides. It will be represented as the difference between pretreatment and post treatment distance from alveolar crest to the CRL, expressed in millimeters.
2 secondary outcomes
Comparison of transverse dental changes between the two groups.
Time frame: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
Assessment of Apical root resorption
Time frame: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.
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 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 aligner and Fixed orthodontic appliance in people with Skeletal Class I Non-extraction Patients With Dental Crowding, run by Mansoura University at 1 site in Egypt.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Jan 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 Egypt. 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?
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?
Alveolar bone thickness (time frame: From date of randomization until the date of first documented acceptable teeth alignment, assessed up to 12 months.). The study lists 2 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 27 Jan 2026.