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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Malaya

About this trial

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)

Eligibility criteria

Qualifiers

Age range: 18 years old and above

Bimaxillary proclination with maximum anchorage control with TAD in maxilla and mandible

Extraction of all four permanent first premolar as part of orthodontic treatment

Crowding in the upper and lower incisors (< 5.0mm)

Disqualifiers

Systemic diseases such as diabetes, osteoporosis

On long term use of antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroid and calcium channel blockers that would affect the bone biology

Cigarette smoking, vaping, history of smoking

Impacted / missing teeth at the treatment site

Trial design

Treatments tested in this trial

  • Temporary Anchorage Device (TAD)
  • Two-step Angulation with Partial Unwinding Technique

Treatment groups

28 Participants
are divided into 2 treatment groups

Sponsors and collaborators