Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques

Summary

The goal of this clinical trial is to learn if two-step angulation Temporary Anchorage Devices (TADs) insertion technique better for survival, stability and patient-reported outcomes. It will also learn about how the trabecular bone volume fraction measured from pre-treatment CBCT imaging influences the stability, survival, and overall clinical success of TADs. The clinical trial will be carried out among fit and healthy adults aged 18 years old above who require extraction of all four permanent first premolars, planned for maximum anchorage using bilateral maxillary and mandibular TADs.

The main questions it aims to answer are:

In orthodontic patients,

* does the two-step angulation insertion technique for TADs provide superior survival, stability, and patient-reported outcomes, with acceptable complication rates?
* how are these outcomes influenced by maxillary and mandibular trabecular bone volume fraction measured on CBCT?

Researchers will compare two-step angulation insertion technique to steady oblique-angled TADs insertion technique to see it provide more superior survival, stability, and patient-reported outcomes, with acceptable complication rates.

Participants will:

* be taken CBCT radiography before TADs insertion
* receive both TADs insertion technique either right or left on both maxilla and mandible between second premolars and first molars
* fill up patient reported outcome questionnaire At immediate post-insertion (T0), post alignment (T1), and subsequently at monthly intervals during en-masse retraction: 1 month (T2), 2 months (T3), 3 months (T4), 4 months (T5), 5 months (T6), 6 months (T7)
* visit the clinic for measurement of TADs stability, clinical assessment of inflammation, mobility and the need for replacement at immediate post-insertion (T0), post alignment (T1), and subsequently at monthly intervals during en-masse retraction: 1 month (T2), 2 months (T3), 3 months (T4), 4 months (T5), 5 months (T6), 6 months (T7)

Conditions

• Bimaxillary Proclination
• Bimaxillary Protrusion

Interventions

DEVICE

Temporary Anchorage Device (TAD)

The TAD (1.6 mm diameter X 6 mm length; J2, Dual-Top Anchor System, Jeil Medical, Seoul, Korea) will be inserted directly against cortical bone surface at 30-45° to the occlusal plane, targeted anatomically between second premolar and first permanent molar. The device will be manually driven into the alveolar bone using a manual torque driver calibrated to a 10 Ncm torque value

DEVICE

Two-step Angulation with Partial Unwinding Technique

* The TAD (1.6 mm diameter X 6 mm length; J2, Dual-Top Anchor System, Jeil Medical, Seoul, Korea) is initially placed against cortical bone surface parallel to the occlusal plane between second premolar and first permanent molar to create an initial osseous indentation. * A slitted rubber stopper will be used to mark the depth of the TAD tip penetration through the cortical bone, predetermined via CBCT assessment of local cortical bone thickness. * The TAD will undergo partial derotation (unwinding) by half the total number of initial insertion turns to slightly back the device away from the cortical bone. * The TADs will then be reangulated to an oblique path of 30-45° relative to the occlusal plane before completing final seating between second premolar and first permanent molar

Sponsors & Collaborators

• University of Malaya

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2028-07-31

Completion

2028-07-31

Countries

• Malaysia

Study Locations