NCT07259720

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

November 1, 2025

Enrollment Period

Same day

First QC Date

November 21, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

En-masse retraction Power arm lenghth CBCT Bone remodeling

Outcome Measures

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.

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

Study Arms (2)

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.

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.

Procedure: TAD-supported En-masse Retraction

Interventions

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.

Group 1: 5 mm Power ArmGroup 2: 9 mm Power Arm

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthodontic Department, Faculty of Dentistry - Al-Azhar University

Cairo, Egypt

Location

Related Links

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student - Orthodontics

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 2, 2025

Study Start

November 1, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2025

Last Updated

December 2, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations