Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
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
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)
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Wan Ying Lee, Master of Oral Science
- 電話番号：014-8416384
- メール：17125177@siswa.um.edu.my
研究場所
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Kuala Lumpur
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Kuala Lumpur、Kuala Lumpur、マレーシア、50603
- Faculty of Dentistry, Universiti Malaya
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コンタクト：
- Wan Ying Lee, Master of Oral Science
- 電話番号：014-8416384
- メール：17125177@siswa.um.edu.my
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主任研究者：
- Saritha Sivarajan
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副調査官：
- Siti Adibah Othman
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副調査官：
- Maziahtul Zawani Munshi
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主任研究者：
- Wan Ying Lee
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Two-step Angulation with Partial Unwinding Technique
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.
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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
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アクティブコンパレータ：Steady Oblique Angulation Technique
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.
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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
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Survival rate
時間枠：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.
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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.
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Success rate
時間枠：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.
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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)
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.
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Primary stability and secondary stability
時間枠：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.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient- reported outcome
時間枠：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.
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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)
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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.
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Trabecular bone volume fraction (BV/TV)
時間枠：During enmasse retraction at Month 6
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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. |
During enmasse retraction at Month 6
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Complications (inflammation, mobility, or need for replacement)
時間枠：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.
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Need for replacement Yes: Need replacement of TADs (IST < 60) No: No need replacement of TADs (IST > 60) |
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.
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研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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