Bimaxillary ProclinationNCT07715851
Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques
A study testing Temporary Anchorage Device (TAD) and Two-step Angulation with Partial Unwinding Technique in people with Bimaxillary Proclination and Bimaxillary Protrusion, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bimaxillary Proclination, Bimaxillary Protrusion
- What is being tested?
- Temporary Anchorage Device (TAD) and Two-step Angulation with Partial Unwinding Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Faculty of Dentistry, Universiti Malaya
Kuala Lumpur, Kuala Lumpur, 50603
Wan Ying Lee, Master of Oral Science, 014-8416384, 17125177@siswa.um.edu.my
Saritha Sivarajan
About this study
Official title: 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:
Read more
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
- Being tested
- Temporary Anchorage Device (TAD), Two-step Angulation with Partial Unwinding Technique
- Keywords
- miniscrew, Temporary Anchorage Device, Bimaxillary Protrusion, Stability, Survival, Patient-reported outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Two-step Angulation with Partial Unwinding TechniqueDevice
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Temporary Anchorage Device (TAD); Device: Two-step Angulation with Partial Unwinding Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
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)
- Mild pain/VAS 1-4
- Moderate pain/VAS 5-6
- 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
Measured: 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)
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.
Measured: During enmasse retraction at Month 6
Complications (inflammation, mobility, or need for replacement)
- 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
- Mobility Mobility will be checked with AnyCheck implant stability meter. Mobility (Kim et al., 2020) Yes: Mobile (IST < 60) No: Not mobile (IST > 60)
- 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bimaxillary ProclinationStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715851
- Sponsor's protocol ID
- DF CD2615/0058(P)
- Other IDs
- UMG-2026
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07715851
- Acronym / sponsor ID
- DF CD2615/0058(P)
- Conditions
- Bimaxillary Proclination, Bimaxillary Protrusion
- Keywords
- miniscrew, Temporary Anchorage Device, Bimaxillary Protrusion, Stability, Survival, Patient-reported outcome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-step Angulation with Partial Unwinding Technique | Experimental | Device: Temporary Anchorage Device (TAD), Device: Two-step Angulation with Partial Unwinding TechniqueThis 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. |
| Steady Oblique Angulation Technique | Active comparator | Device: Temporary Anchorage Device (TAD), Device: Two-step Angulation with Partial Unwinding TechniqueThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Steady Oblique Angulation Technique, Two-step Angulation with Partial Unwinding Technique |
| 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 | Device | Steady Oblique Angulation Technique, Two-step Angulation with Partial Unwinding Technique |
Primary outcome
Survival rate
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
Patient- reported outcome
Time frame: 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)
Time frame: During enmasse retraction at Month 6
Complications (inflammation, mobility, or need for replacement)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Anchorage Device (TAD) and Two-step Angulation with Partial Unwinding Technique in people with Bimaxillary Proclination and Bimaxillary Protrusion, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wan Ying Lee, Master of Oral Science (014-8416384, 17125177@siswa.um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.