Survival, Success, Stability, and Patient Comfort of TADs Placed by Steady Oblique-Angled Versus Two-Step Angulation Insertion Techniques | NCT07715851

NCT07715851

Overview

NCT ID: NCT07715851
Lead Sponsor: University of MalayaOTHER
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
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)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Jul 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 28Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Wan Ying Lee, Master of Oral ScienceContact
17125177@siswa.um.edu.my

Similar Studies

Participant Group/Arms

Two-step Angulation with Partial Unwinding TechniqueExperimental

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.

Device: Temporary Anchorage Device (TAD)

Device: Two-step Angulation with Partial Unwinding Technique

Steady Oblique Angulation TechniqueActive 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.

Device: Temporary Anchorage Device (TAD)