Comparing 3D-printed and thermoformed retainers for orthodontic stability
Post-Treatment Stability, Changes in Mechanical Properties and Patients' OHRQoL Of Direct 3D-Printed Retainers Versus Thermoformed Retainers: An Open-label Randomized Controlled Trial
This study is testing whether 3D-printed retainers or traditional thermoformed retainers do a better job of keeping teeth stable after orthodontic treatment and how they affect patients' quality of life over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Malaya Academic / other |
| Locations | 1 site (Kuala Lumpur, Wilayah Persekutuan) |
| Trial ID | NCT05968625 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of 3D-printed retainers and conventional thermoformed retainers in maintaining post-treatment stability of teeth after orthodontic treatment. It will assess the changes in mechanical properties and thickness of the retainers over a six-month retention period. Additionally, the study will evaluate the oral health-related quality of life (OHRQoL) of patients using both types of retainers at three different time points: baseline, three months, and six months post-treatment. Participants will be randomly assigned to receive either type of retainer after completing their orthodontic treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals who have completed fixed orthodontic treatment and are ready for the retention phase.
Not a fit: Patients with single-arch appliances, hypodontia, or those requiring fixed retainers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which type of retainer offers better stability and quality of life for orthodontic patients.
How similar studies have performed: Previous studies have shown varying results in the effectiveness of different types of retainers, but this specific comparison of 3D-printed versus thermoformed retainers is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fixed appliance treatment in both arches and indicated for VFR in the retention phase as part of their original treatment plan. * No intention to relocate within the study period; able to attend the three-monthly review appointments for half a year. Exclusion Criteria: * Single-arch or sectional fixed appliances. * Space dentition. * Hypodontia requiring tooth replacement on the retainer as a temporary measure. * Previous treatment with maxillary expansion. * Indicated for fixed retainer or double retention regime (such as VFRs fitted over fixed retainers). * Premature debond from the original fixed appliances course. * Cleft lip and/or palate; or orthognathic cases. * Learning difficulties and inability to read written instructions/ questionnaire in English or Malay
Where this trial is running
Kuala Lumpur, Wilayah Persekutuan
- Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya. — Kuala Lumpur, Wilayah Persekutuan, Malaysia (Recruiting)
Study contacts
- Study coordinator: Dr. Boo Hui Shan
- Email: 17080312@siswa.um.edu.my
- Phone: +60102705306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.