- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07259720
Dento-Alveolar Changes in Maxillary Incisors After En-Masse Retraction Using Two Power-Arm Heights (DA-RET)
Dento-Alveolar Changes in Maxillary Incisors After Orthodontic En-mass Retraction by Two Levels of Force Application
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Orthodontic Department, Faculty of Dentistry - Al-Azhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
- 1. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Smoking history. 4. Presence of periodontal diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (before retraction) and after space closure (approximately 6-9 months)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZH-ORTHO-RET-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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