Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
Starting soon · Not applicable
Conditions studied: Bimaxillary Proclination, Bimaxillary Protrusion
In brief
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)
Key facts
- Study ID
- NCT07715851
- Run by
- University of Malaya
- People needed
- 28
- Starts
- 2026-08-01
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Overjet less than 6mm
- BPE score 0, 1 or 2
- Average vertical facial proportions
You may not qualify if…
- 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
- BPE score 3 and 4
- Vertical skeletal discrepancies e.g. high angle and low angle.
- Orthognathic treatment need
- Craniofacial disorder, cleft lip and palate, syndromes
- Low maxillary sinus level with alveolar crest height of less than 4mm
- Titanium allergy
- Pregnant woman
Where it is running
- Faculty of Dentistry, Universiti Malaya — Kuala Lumpur, Kuala Lumpur, Malaysia
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.