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

14. juli 2026 oppdatert av: University of Malaya

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)

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

28

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Faculty of Dentistry, Universiti Malaya
        • Ta kontakt med:
        • Hovedetterforsker:
          • Saritha Sivarajan
        • Underetterforsker:
          • Siti Adibah Othman
        • Underetterforsker:
          • Maziahtul Zawani Munshi
        • Hovedetterforsker:
          • Wan Ying Lee

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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
Enhet: 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 (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
Aktiv komparator: 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.
Enhet: 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
Enhet: 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 (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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Survival rate
Tidsramme: 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)
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
Tidsramme: 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
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
Tidsramme: 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
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient- reported outcome
Tidsramme: 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
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)
Tidsramme: 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.
During enmasse retraction at Month 6
Complications (inflammation, mobility, or need for replacement)
Tidsramme: 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)
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Malaya

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

31. juli 2028

Studiet fullført (Antatt)

31. juli 2028

Datoer for studieregistrering

Først innsendt

9. juli 2026

Først innsendt som oppfylte QC-kriteriene

14. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • DF CD2615/0058(P)
  • UMG-2026 (Annet stipend/finansieringsnummer: Universiti Malaya)

Plan for individuelle deltakerdata (IPD)

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NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Nei

produkt produsert i og eksportert fra USA

Nei

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