Malocclusion, Angle Class II, Division 1DA-RETNCT07259720
Dento-Alveolar Changes in Maxillary Incisors After En-Masse Retraction Using Two Power-Arm Heights
A study testing TAD-supported En-masse Retraction in people with Malocclusion, Angle Class II, Division 1, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Malocclusion, Angle Class II, Division 1
- What is being tested?
- TAD-supported En-masse Retraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Nov 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Smoking history. 4. Presence of periodontal diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Orthodontic Department, Faculty of Dentistry - Al-Azhar University
Cairo
About this study
Official title: Dento-Alveolar Changes in Maxillary Incisors After Orthodontic En-mass Retraction by Two Levels of Force Application
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.
- Conditions
- Malocclusion, Angle Class II, Division 1
- Being tested
- TAD-supported En-masse Retraction
- Keywords
- En-masse retraction Power arm lenghth CBCT Bone remodeling
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAD-supported En-masse RetractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: 5 mm Power Arm | Experimental | 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. Receives: Procedure: TAD-supported En-masse Retraction |
| Group 2: 9 mm Power Arm | Experimental | 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. Receives: Procedure: TAD-supported En-masse Retraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before retraction) and after space closure (approximately 6-9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Nov 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class II, Division 1Studies 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
- Participants were randomly assigned into two parallel groups receiving different power-arm lengths (5 mm vs 9 mm) during en-masse retraction. Each group followed the same orthodontic protocol except for the intervention difference.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rania Alzany, Faculty of Dental Medicine for Girls
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259720
- Sponsor's protocol ID
- AZH-ORTHO-RET-2025
- Acronym
- DA-RET
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dento-Alveolar Changes in Maxillary Incisors After Orthodontic En-mass Retraction by Two Levels of Force Application
- ClinicalTrials.gov ID
- NCT07259720
- Acronym / sponsor ID
- DA-RET / AZH-ORTHO-RET-2025
- Conditions
- Malocclusion, Angle Class II, Division 1
- Keywords
- En-masse retraction Power arm lenghth CBCT Bone remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 2 Dec 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned into two parallel groups receiving different power-arm lengths (5 mm vs 9 mm) during en-masse retraction. Each group followed the same orthodontic protocol except for the intervention difference.
| Arm | Type | Receives |
|---|---|---|
| Group 1: 5 mm Power Arm | Experimental | Procedure: TAD-supported En-masse RetractionOrthodontic 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. |
| Group 2: 9 mm Power Arm | Experimental | Procedure: TAD-supported En-masse RetractionOrthodontic 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Smoking history. 4. Presence of periodontal diseases.
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 |
|---|---|---|
| TAD-supported En-masse RetractionOrthodontic 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. | Procedure or surgery | Group 1: 5 mm Power Arm, Group 2: 9 mm Power Arm |
Primary outcome
Dentoalveolar changes of maxillary incisors after en-masse retraction using different power arm heights
Time frame: Baseline (before retraction) and after space closure (approximately 6-9 months)
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.
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 2 Dec 2025.
- CBCT-based evaluation of en-masse retraction biomechanics.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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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.
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 TAD-supported En-masse Retraction in people with Malocclusion, Angle Class II, Division 1, run by Faculty of Dental Medicine for Girls 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 2 inclusion and 1 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 2 Dec 2025. 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?
Dentoalveolar changes of maxillary incisors after en-masse retraction using different power arm heights (time frame: Baseline (before retraction) and after space closure (approximately 6-9 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 2 Dec 2025.