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CompletedNCT07259720DA-RETUpdated Dec 2, 2025

Dento-Alveolar Changes in Maxillary Incisors After En-Masse Retraction Using Two Power-Arm Heights

An interventional study of TAD-supported En-masse Retraction in Malocclusion, Angle Class II, Division 1, sponsored by Faculty of Dental Medicine for Girls. Completed at 1 site in Egypt. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Nov 2023, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study summary

This study aims to evaluate the dento-alveolar changes associated with en-masse retraction of the maxillary anterior teeth using two different power-arm lengths to produce two distinct levels of force application. Twenty patients were randomly assigned into two equal groups. Group I received en-masse retraction using a 5-mm power arm, while Group II was treated using a 9-mm power arm. Cone-beam computed tomography (CBCT) was used to measure changes in buccal bone thickness at 3 mm, 6 mm, and 9 mm levels before and after retraction. The purpose of the study is to assess the influence of power-arm length on force direction, bone remodeling, and the safety of anterior tooth movement.

Read the detailed description

The study was conducted to assess the dento-alveolar changes that occur during the en-masse retraction of maxillary anterior teeth when using two different power-arm lengths. Twenty orthodontic patients who required extraction of the maxillary first premolars as part of their treatment plan were included. Patients were selected according to well-defined inclusion criteria to ensure uniformity in skeletal pattern, dental status, and oral health. Any patients with previous orthodontic treatment, periodontal problems, or systemic conditions that could influence bone metabolism were excluded.

After obtaining approval from the Research Ethics Committee, participants were randomly divided into two equal groups. In Group I, retraction was carried out using a 5-mm power arm, while Group II was treated with a 9-mm power arm incorporated into the main archwire. All patients were treated with the same fixed orthodontic system, and temporary anchorage devices (TADs) were placed bilaterally to provide maximum anchorage. The archwire sequence, appointment intervals, and force application protocol were standardized for both groups to reduce variability.

Cone-beam computed tomography (CBCT) scans were taken for each patient before initiating retraction and after the completion of space closure. Buccal bone thickness was measured at three levels along the root (3 mm, 6 mm, and 9 mm from the cementoenamel junction). Measurements were recorded on the right and left sides and averaged. Additional clinical parameters-including the amount of anterior tooth movement, changes in incisor inclination, and any alterations in the occlusal plane-were evaluated to understand the mechanical implications of each power-arm length.

The main focus of the study was to determine how the length of the power arm affects the direction of force, the biomechanics of retraction, and the subsequent pattern of alveolar bone remodeling. All measurements were analyzed using appropriate statistical tests to compare differences between groups and between pre- and post-treatment values. The study aims to provide practical clinical guidance regarding the optimal choice of power-arm length to achieve effective, controlled anterior retraction while maintaining alveolar bone health.

02

Conditions studied

  • Malocclusion, Angle Class II, Division 1

Keywords

  • En-masse retraction Power arm lenghth CBCT Bone remodeling
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In context

Malocclusion, Angle Class II

124 studies on the registry are indexed under Malocclusion, Angle Class II; 19 are open to participants now.

This study's enrollment of 20 is below the median of 34 across 115 interventional studies indexed under Malocclusion, Angle Class II.

Browse Malocclusion, Angle Class II studies →

Lead sponsor

Faculty of Dental Medicine for Girls is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 1. Aged from 18 to 25 years. 2. Patients indicated for extraction of maxillary first premolars (those with Angle's Class I bimaxillary protrusion or Angle's Class II Division I malocclusion).

    3. Good oral hygiene. 4. Healthy compliant and motivated patient. 5. Full dentition in maxillary arch except wisdom teeth.

Exclusion criteria

Exclusion Criteria:

  • 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Smoking history. 4. Presence of periodontal diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Group 1: 5 mm Power Arm

    Orthodontic en-masse retraction using temporary anchorage devices (TADs) with a 5 mm power arm height for force application. Maxillary incisors are retracted as a single unit following first premolar extraction.

    Procedure: TAD-supported En-masse Retraction

  • Experimental
    Group 2: 9 mm Power Arm

    Orthodontic en-masse retraction using temporary anchorage devices (TADs) with a 9 mm power arm height for force application. Maxillary incisors are retracted as a single unit following first premolar extraction.

    Procedure: TAD-supported En-masse Retraction

Interventions

  • ProcedureTAD-supported En-masse Retraction

    Orthodontic en-masse retraction of maxillary incisors using temporary anchorage devices (TADs) with different power arm heights following first premolar extraction. The intervention involves controlled retraction mechanics using a 0.017×0.025 stainless steel archwire and vertical power arms to alter the moment-arm and force system.

06

What researchers measure

Primary outcomes

  1. Dentoalveolar changes of maxillary incisors after en-masse retraction using different power arm heights

    Evaluation of maxillary incisor dentoalveolar changes following orthodontic en-masse retraction using temporary anchorage devices (TADs) with different power arm heights. Measurements include incisor inclination, root position, buccal and palatal alveolar bone thickness, and alveolar crest level changes assessed by CBCT.

    Time frame: Baseline (before retraction) and after space closure (approximately 6-9 months)

07

Study locations

1 site
  • Orthodontic Department, Faculty of Dentistry - Al-Azhar University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No — Individual participant data (IPD) will not be shared because the study is retrospective and the data includes identifiable clinical and radiographic records that cannot be publicly released.

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 Nov 2023 to primary completion in Nov 2023, 0 months.

Of 86 non-industry interventional studies with no phase under Malocclusion, Angle Class II, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 22. This study's 0 months is below that.

Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 11 and three quarters within 22.

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

Registered
Nov 21, 2025
First posted
Dec 2, 2025
StartActual
Nov 1, 2023
Primary completionActual
Nov 1, 2023
CompletionActual
Nov 1, 2025
Last update
Dec 2, 2025
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 Dec 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07259720
Lead sponsor
Faculty of Dental Medicine for Girls
Responsible party
Rania Alzany (Postgraduate Student - Orthodontics, Faculty of Dental Medicine for Girls) — Principal investigator
First posted
Dec 2, 2025
Start date
Nov 1, 2023
Primary completion
Nov 1, 2023
Completion
Nov 1, 2025
Last update
Dec 2, 2025

Oversight

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

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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