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

NCT07715851 | Not Yet Recruiting DMC

• 2 other identifiers: DF CD2615/0058(P)UMG-2026
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

miniscrew; Temporary Anchorage Device; Bimaxillary Protrusion; Stability; Survival; Patient-reported outcome

Outcome Measures

Primary Outcomes (3)

• Survival rate

  Survival Rate Percentage of TADs that remain physically retained in bone (not necessarily stable for orthodontic load) over 6 months, regardless of whether they are functionally useful (Schätzle et al., 2009) Citeria of Survived TADs Retain in bone regardless function and complications. Mininum value:0% Maximum value: 100% Higher value indicate greater percentage of TADs that remain physically retained in bone (not necessarily stable for orthodontic load)

  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

  Success Rate Percentage of TADs that remain functionally stable and serve their orthodontic purpose throughout treatment, without mobility, infection, or premature failure (Dalessandri et al., 2014) Citeria of Success TADs (Sharma et al., 2011) * No inflammation of soft tissue surrounding TADs * No clinically detectable mobility (IST \> 60) * Anchorage function sustained until the end of the purpose for which the TADs were used Mininum value:0% Maximum value: 100% Higher value indicate higher percentage of TADs that remain functionally stable and serve their orthodontic purpose throughout treatment, without mobility, infection, or premature failure

  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

  Primary stability Mechanical retention of a TAD immediately after placement, derived from the mechanical interlocking between the screw threads and the surrounding bone (Seifi \& Matini, 2016) Secondary stability Biological stabilisation of a TAD that occurs after healing and remodelling, primarily due to bone apposition and osseointegration around the device (Wu et al., 2021) AnyCheck Implant Stability Meter (Figure 3.8) to determine stability of TADs by measuring implant Stability Test (iST) value at insertion T0 to T9. Min value: 1 Max value: 99 Higher value indicate high stability of TADs Interpretation of iST (Kim et al., 2020) IST Range Interpretation \<60 Low primary stability 60-64 Moderate stability \>64 High stability

  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 Outcomes (3)

• Patient- reported outcome

  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)

  During enmasse retraction at Month 6

• Complications (inflammation, mobility, or need for replacement)

  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.

Study Arms (2)

Two-step Angulation with Partial Unwinding Technique

EXPERIMENTAL

This is a split-mouth randomized clinical trial design where each participant serves as their own internal control. This arm represents the specific jaw quadrants randomized to receive Temporary Anchorage Device (TAD) insertion using a two-step angulation with a partial unwinding technique. The TAD is first placed parallel to the occlusal plane to create a cortical bone indentation (guided by a rubber depth stopper based on CBCT bone thickness), partially backed out (derotated) by half a turn, and subsequently reangulated to a final seating angle of 30-45 degree relative to the occlusal plane between the second premolar and first permanent molar.

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

Steady Oblique Angulation Technique

ACTIVE COMPARATOR

This is a split-mouth randomized clinical trial design where each participant serves as their own internal control. This arm represents the specific jaw quadrants randomized to receive Temporary Anchorage Device (TAD) insertion via a single-step, steady oblique angulation approach. The screw is inserted directly into the alveolar bone at a constant angle of 30 to 45 degree relative to the occlusal plane, targeted anatomically between the second premolar and first permanent molar.

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

Interventions

Temporary Anchorage Device (TAD) DEVICE

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

Steady Oblique Angulation Technique; Two-step Angulation with Partial Unwinding Technique

Two-step Angulation with Partial Unwinding Technique DEVICE

* 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

Steady Oblique Angulation Technique; Two-step Angulation with Partial Unwinding Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Central Study Contacts

Wan Ying Lee, Master of Oral Science

CONTACT

014-8416384; 17125177@siswa.um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: CBCT datasets will be de-identified and assigned unique random codes by an independent researcher. This ensures that the examiner measuring bone volume fraction and TAD stability remains blinded to the quadrant-specific technique and the subject's group affiliation. The final statistical analysis will be performed on coded datasets, ensuring that the statistician remains unaware of the 'steady oblique' versus 'two-step insertion with partial unwinding' assignments until the analysis is complete and the code is broken.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 21, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)