ClinicalTrials.gg
CompletedNCT07716007Updated Jul 21, 2026

Bone Level Changes Using Clear Aligners Compared to Fixed Appliances in Non-Extraction Treatment of Adults

An interventional study of Fixed orthodontic appliance and Clear aligners in Dental Crowding, Alveolar Bone Loss and Malocclusion, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Aug 2024, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • 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
  • rate of alignment
  • non-extraction treatment
  • adults
03

In context

Crowding

88 studies on the registry are indexed under Crowding; 22 are open to participants now.

This study's enrollment of 20 is below the median of 36 across 74 interventional studies indexed under Crowding.

Browse Crowding studies →

Lead sponsor

Future University in Egypt is the lead sponsor of 104 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Fixed appliances (Group FA)

    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.

    Device: Fixed orthodontic appliance

  • Experimental
    Clear aligners (Group CA)

    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

    Device: Clear aligners

Interventions

  • DeviceFixed orthodontic appliance

    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.

    Also known as: Conventional labial brackets, pre-adjusted edgewise appliance (0.022 MBT)

  • DeviceClear 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.

    Also known as: sequential clear aligners, Thermoformed removable aligners

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (T0) and end of alignment phase (T3)) (approximately 6 months)

Secondary outcomes

  1. 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.

    Time frame: Baseline (T0) and end of alignment phase (≈ 6 months)

  2. 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.

    Time frame: Baseline (T0) and end of alignment phase (≈ 6 months)

  3. 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.

    Time frame: Baseline (T0), 8 weeks (T1), 16 weeks (T2) and end of alignment (T3, ≈ 24 weeks / 6 months)

07

Study locations

1 site
  • Faculty of Oral and Dental Medicine, Future University in Egypt (Department of Orthodontics)
    Cairo, 11865, Egypt
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2024 to primary completion in Jul 2025, 11 months.

Of 50 non-industry interventional studies with no phase under Crowding, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's 11 months is below that.

Counting every sponsor, half of 52 studies reached it within 17 months; a quarter within 11 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2026
First posted
Jul 21, 2026
StartActual
Aug 15, 2024
Primary completionActual
Jul 25, 2025
CompletionActual
Apr 15, 2026
Last update
Jul 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07716007
Responsible party
Ahmed Mohamed Hesham (Postgraduate researcher (orthodontic resident), Department of Orthodontics, Future University in Egypt) — Principal investigator
First posted
Jul 21, 2026
Start date
Aug 15, 2024
Primary completion
Jul 25, 2025
Completion
Apr 15, 2026
Last update
Jul 21, 2026

Study contacts

ahmed mohamed hesham elzoghary
principal investigator · Faculty of Oral and Dental Medicine, Future University in Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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