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

Official title

Survival, Success, Stability, and Patient Comfort of Temporary Anchorage Devices Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques: A Split-Mouth Randomised Clinical Trial

Overview

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)

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 (unwind

Primary outcome measures

• Survival rate [Time frame: Post alignment (at the start of enmasse retraction), and subsequently at monthly intervals during en-masse retraction: Month 1, Month 2, Months 3, Month 4, Months 5, Months 6.]
• Success rate [Time frame: at immediate post-insertion (Day 0), post alignment (at the start of en-masse retraction), and subsequently at monthly intervals during en-masse retraction: Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6.]
• Primary stability and secondary stability [Time frame: at immediate post-insertion (Day 0), post alignment (at the start of en-masse retraction), and subsequently at monthly intervals during en-masse retraction: Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6.]

Secondary outcome measures (3)

• Patient- reported outcome [Time frame: at immediate post-insertion (Day 0), post alignment (at the start of en-masse retraction), and subsequently at monthly intervals during en-masse retraction: Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6.]
• Trabecular bone volume fraction (BV/TV) [Time frame: During enmasse retraction at Month 6]
• Complications (inflammation, mobility, or need for replacement) [Time frame: at immediate post-insertion (Day 0), post alignment (at the start of en-masse retraction), and subsequently at monthly intervals during en-masse retraction: Month 1, Month 2, Month 3, Month 4, Month 5, and Month 6.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Malaysia · 1 center

• Faculty of Dentistry, Universiti Malaya — Kuala Lumpur

Identifiers

NCT: NCT07715851 · DF CD2615/0058(P) · UMG-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗