Bimaxillary Proclination, Bimaxillary Protrusion
Conditions
Keywords
miniscrew, Temporary Anchorage Device, Bimaxillary Protrusion, Stability, Survival, Patient-reported outcome
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)
Interventions
DEVICETemporary 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
DEVICETwo-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
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 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. | 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) |
| Success rate | 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. | 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 |
| Primary stability and secondary 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Patient perception of pain at each quadrant (upper right, upper left, lower right, and lower left jaw) will be measured with a four-point Likert scale correlated with a 10-point Visual Analogue Scale (VAS). Perceptions of swelling, chewing difficulty, and cleaning difficulty at each jaw quadrant will be captured using categorical dichotomous responses (Yes or No). Patient reported outcome questionnaires (Appendix 2): Patient perception of pain 0: No pain/VAS 0) 1. Mild pain/VAS 1-4 2. Moderate pain/VAS 5-6 3. Severe or worsening pain/VAS 7-10 Perceptions of swelling, chewing difficulty, and cleaning difficulty Yes: Presence of swelling/ chewing difficulty/ cleaning difficulty No: Absence of swelling/ chewing difficulty/ cleaning difficulty |
| Trabecular bone volume fraction (BV/TV) | During enmasse retraction at Month 6 | Percentage of the volume of mineralized trabecular bone (bone volume, BV) to the total volume (TV) of the region of interest within cancellous bone. Association between maxillary and mandibular trabeculae bone volume fraction with TADs stability, survival and success White region: (Bruker, 2013) Solid regions of the bony trabeculae areas within the range of the binary threshold selection Black region: Spaces among the bong mandibular trabeculae Min value: 1% Max value: 99% Higher value indicate higher percentage of the volume of mineralized trabecular bone (bone volume, BV) to the total volume (TV) of the region of interest within cancellous bone. ercentage of the volume of mineralized trabecular bone (bone volume, BV) to the total volume (TV) of the region of interest within cancellous bone. |
| 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. | 1. Inflammation Redness, swelling or bleeding on touching around the neck of the TADs (Park et al., 2006; Samrit et al., 2012) Inflammation (Park et al., 2006; Samrit et al., 2012) Yes: Presence of redness, swelling or bleeding on touching around the neck of the TADs No: Absence of redness, swelling or bleeding on touching around the neck of the TADs 2. Mobility Mobility will be checked with AnyCheck implant stability meter. Mobility (Kim et al., 2020) Yes: Mobile (IST \< 60) No: Not mobile (IST \> 60) 3. Need for replacement of TADs Removal and reinsertion of a TADs at a new or the same site due to loss of stability, inflammation, root contact, soft-tissue complications, or poor anchorage performance during orthodontic treatment. Need for replacement Yes: Need replacement of TADs (IST \< 60) No: No need replacement of TADs (IST \> 60) |
Countries
Malaysia
Contacts
CONTACTWan Ying Lee, Master of Oral Science
Outcome results
None listed