Dental CrowdingNCT07716007
Bone Level Changes Using Clear Aligners Compared to Fixed Appliances in Non-Extraction Treatment of Adults
A study testing Fixed orthodontic appliance and Clear aligners in people with Dental Crowding and Alveolar Bone Loss, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This study compares two common ways of straightening teeth in adults who have mild-to-moderate crowding of the lower front teeth and do not need any teeth removed: clear aligners and traditional fixed braces. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Crowding, Alveolar Bone Loss, Malocclusion
- What is being tested?
- Fixed orthodontic appliance and Clear aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2024to 15 Apr 2026
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18-25 years of age, of both sexes.
- Mild-to-moderate mandibular anterior crowding (2-6 mm).
- Angle Class I molar relationship with normal overjet (1-3 mm) and overbite (1-2 mm).
- Full permanent dentition with a healthy periodontium.
- Normal anteroposterior and vertical skeletal pattern.
Who cannot join
- Any local or systemic condition, or trauma, capable of affecting craniofacial growth and development.
- History of previous orthodontic or interceptive treatment.
- Loss of periodontal attachment.
- Craniofacial anomalies, facial asymmetry or skeletal discrepancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Oral and Dental Medicine, Future University in Egypt (Department of Orthodontics)
Cairo, 11865
About this study
Official title: Evaluation of Bone Level Changes Using Clear Aligners Compared to Fixed Appliances in Non-extraction Treatment of Adult Patients: A Randomized Clinical Trial
This study compares two common ways of straightening teeth in adults who have mild-to-moderate crowding of the lower front teeth and do not need any teeth removed: clear aligners and traditional fixed braces.
The main aim is to find out whether the two methods differ in how they affect the bone that surrounds the teeth. Using three-dimensional X-ray scans (cone-beam CT) and digital models of the teeth taken before and during treatment, the researchers measure the level and thickness of the bone around the lower front teeth, the tilt (inclination) of the lower front teeth, and how quickly the crowding is corrected.
Adults are randomly assigned to receive either clear aligners or fixed braces, and the same measurements are compared between the two groups over about six months.
- Conditions
- Dental Crowding, Alveolar Bone Loss, Malocclusion
- Being tested
- Fixed orthodontic appliance, Clear aligners
- Keywords
- clear aligners, fixed orthodontic appliances, alveolar bone level, alveolar bone thickness, cone-beam computed tomography, incisor inclination, torque, Little's Irregularity Index, rate of alignment, non-extraction treatment, adults
- Medical subject headings
- Crowding, Alveolar Bone Loss, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed orthodontic applianceDevice
Also called Conventional labial brackets, pre-adjusted edgewise appliance (0.022 MBT)
Brackets bonded first-molar-to-first-molar; alignment sequence 0.014" NiTi → 0.016" NiTi → 0.016 × 0.022" NiTi → 0.017 × 0.025" stainless steel. Interproximal reduction performed on assigned contacts where indicated.
Clear alignersDevice
Also called sequential clear aligners, Thermoformed removable aligners
Digital intraoral scan and staging (3Shape Ortho Analyzer); 3D-printed models thermoformed into aligners; attachments bonded where planned; sequential aligners worn ~22 h/day. Interproximal reduction per contact from canine-to-canine is done.
| Study group | Role | What they receive |
|---|---|---|
| Fixed appliances (Group FA) | Active comparator | Conventional pre-adjusted edgewise fixed appliance (0.022-inch slot, MBT prescription) bonded from first molar to first molar; levelling and alignment with a sequence of nickel-titanium and stainless-steel archwires over approximately six months. Receives: Device: Fixed orthodontic appliance |
| Clear aligners (Group CA) | Experimental | Three-dimensionally printed, thermoformed clear aligners with bonded attachments and interproximal reduction as indicated; worn ~22 hours/day and changed per the digital staging, with clinical review every four weeks over approximately six months Receives: Device: Clear aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar bone level
Change (mm) in the distance from the cemento-enamel junction to the alveolar crest on the labial and lingual aspects of the mandibular central incisors, lateral incisors and canines, measured on CBCT (OnDemand software), calculated as the difference between baseline and end-of-alignment values.
Measured: Baseline (T0) and end of alignment phase (T3)) (approximately 6 months)
Secondary outcomes (3)
Change in alveolar bone thickness
Change (mm) in labial and lingual alveolar bone thickness measured at 3 mm and 6 mm from the CEJ and at the root apex of the mandibular central incisors, lateral incisors and canines on CBCT (OnDemand software), from baseline to end of alignment.
Measured: Baseline (T0) and end of alignment phase (≈ 6 months)
Change in mandibular incisor inclination (torque)
Change (degrees) in the inner angle between the long axis of each mandibular central incisors, lateral incisors and canines and the mandibular plane, measured on the sagittal view of CBCT (Invivo/Anatomage software), from baseline to end of alignment.
Measured: Baseline (T0) and end of alignment phase (≈ 6 months)
Rate of alignment (Little's Irregularity Index)
Reduction in mandibular anterior crowding quantified by Little's Irregularity Index (mm) - the sum of the displaced anatomic contact points from canine to canine - measured on serial digital models; the change across time points and the percentage improvement from baseline describe the rate of alignment.
Measured: Baseline (T0), 8 weeks (T1), 16 weeks (T2) and end of alignment (T3, ≈ 24 weeks / 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start15 Aug 2024
- Primary completion25 Jul 2025
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CrowdingStudies 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
- Model description
- Two arms in parallel; participants are assigned 1:1 to clear aligners or fixed appliances for the full \~6-month levelling and alignment phase.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Hesham, Future University in Egypt
- Investigators
- ahmed mohamed hesham elzoghary, Principal investigator, Faculty of Oral and Dental Medicine, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716007
- Sponsor's protocol ID
- FUE.REC (18)/7-2024
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bone Level Changes Using Clear Aligners Compared to Fixed Appliances in Non-extraction Treatment of Adult Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07716007
- Acronym / sponsor ID
- FUE.REC (18)/7-2024
- Conditions
- Dental Crowding, Alveolar Bone Loss, Malocclusion
- Keywords
- clear aligners, fixed orthodontic appliances, alveolar bone level, alveolar bone thickness, cone-beam computed tomography, incisor inclination, torque, Little's Irregularity Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 21 Jul 2026 (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.
This study compares two common ways of straightening teeth in adults who have mild-to-moderate crowding of the lower front teeth and do not need any teeth removed: clear aligners and traditional fixed braces.
The main aim is to find out whether the two methods differ in how they affect the bone that surrounds the teeth. Using three-dimensional X-ray scans (cone-beam CT) and digital models of the teeth taken before and during treatment, the researchers measure the level and thickness of the bone around the lower front teeth, the tilt (inclination) of the lower front teeth, and how quickly the crowding is corrected.
Adults are randomly assigned to receive either clear aligners or fixed braces, and the same measurements are compared between the two groups over about six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms in parallel; participants are assigned 1:1 to clear aligners or fixed appliances for the full ~6-month levelling and alignment phase.
| Arm | Type | Receives |
|---|---|---|
| Fixed appliances (Group FA) | Active comparator | Device: Fixed orthodontic applianceConventional pre-adjusted edgewise fixed appliance (0.022-inch slot, MBT prescription) bonded from first molar to first molar; levelling and alignment with a sequence of nickel-titanium and stainless-steel archwires over approximately six months. |
| Clear aligners (Group CA) | Experimental | Device: Clear alignersThree-dimensionally printed, thermoformed clear aligners with bonded attachments and interproximal reduction as indicated; worn ~22 hours/day and changed per the digital staging, with clinical review every four weeks over approximately six months |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults 18-25 years of age, of both sexes.
- Mild-to-moderate mandibular anterior crowding (2-6 mm).
- Angle Class I molar relationship with normal overjet (1-3 mm) and overbite (1-2 mm).
- Full permanent dentition with a healthy periodontium.
- Normal anteroposterior and vertical skeletal pattern.
Key exclusion criteria (4 listed)
- Any local or systemic condition, or trauma, capable of affecting craniofacial growth and development.
- History of previous orthodontic or interceptive treatment.
- Loss of periodontal attachment.
- Craniofacial anomalies, facial asymmetry or skeletal discrepancy.
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 |
|---|---|---|
| Fixed orthodontic applianceAlso: Conventional labial brackets, pre-adjusted edgewise appliance (0.022 MBT)Brackets bonded first-molar-to-first-molar; alignment sequence 0.014" NiTi → 0.016" NiTi → 0.016 × 0.022" NiTi → 0.017 × 0.025" stainless steel. Interproximal reduction performed on assigned contacts where indicated. | Device | Fixed appliances (Group FA) |
| Clear alignersAlso: sequential clear aligners, Thermoformed removable alignersDigital intraoral scan and staging (3Shape Ortho Analyzer); 3D-printed models thermoformed into aligners; attachments bonded where planned; sequential aligners worn ~22 h/day. Interproximal reduction per contact from canine-to-canine is done. | Device | Clear aligners (Group CA) |
Primary outcome
Change in alveolar bone level
Time frame: Baseline (T0) and end of alignment phase (T3)) (approximately 6 months)
Change (mm) in the distance from the cemento-enamel junction to the alveolar crest on the labial and lingual aspects of the mandibular central incisors, lateral incisors and canines, measured on CBCT (OnDemand software), calculated as the difference between baseline and end-of-alignment values.
3 secondary outcomes
Change in alveolar bone thickness
Time frame: Baseline (T0) and end of alignment phase (≈ 6 months)
Change in mandibular incisor inclination (torque)
Time frame: Baseline (T0) and end of alignment phase (≈ 6 months)
Rate of alignment (Little's Irregularity Index)
Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2) and end of alignment (T3, ≈ 24 weeks / 6 months)
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 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Crowding
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RecruitingObservational study
Exploration of the Utility of Dental-dedicated MRI for Dentistry
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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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed mohamed hesham elzoghary principal investigator
Faculty of Oral and Dental Medicine, Future University in Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed orthodontic appliance and Clear aligners in people with Dental Crowding and Alveolar Bone Loss, run by Future University in Egypt 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 5 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 21 Jul 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?
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 alveolar bone level (time frame: Baseline (T0) and end of alignment phase (T3)) (approximately 6 months)). 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 21 Jul 2026.