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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Survival rate
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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.)