Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic Treatment (NCT07687329) | Clinical Trial Compass
CompletedNot Applicable
Direct vs Indirect In-House Clear Aligners vs Fixed Appliances in Orthodontic Treatment
Turkey (Türkiye)36 participantsStarted 2024-02-15
Plain-language summary
Clear aligner therapy has become increasingly popular as an esthetic alternative to conventional braces in orthodontic treatment. While clear aligners are traditionally manufactured by commercial laboratories using a thermoforming technique, recent advances in 3D printing technology now allow clinicians to produce aligners directly in their own clinic, either by printing the aligner itself (direct method) or by printing a model and then thermoforming the aligner over it (indirect method)." "This study compares three approaches to orthodontic treatment in patients with mild to moderate dental crowding who do not require tooth extraction: clear aligners produced directly in-house using 3D printing with a shape-memory resin, clear aligners produced indirectly in-house using a 3D-printed model and thermoforming, and conventional fixed orthodontic treatment with metal brackets and wires." "A total of 36 patients aged 12 to 30 years were randomly assigned to one of these three treatment groups, and 33 patients completed the study. Treatment quality was evaluated using the American Board of Orthodontics Objective Grading System (ABO-OGS), an objective scoring method based on dental models obtained at the end of treatment. The total duration of treatment, from the start of active treatment to its completion, was also compared among the three groups." "The findings of this study may help clinicians and patients better understand the advantages and limitations of in-house clear aligner production compared to conventional fixed appliances, particularly regarding treatment efficiency and duration.
Who can participate
Age range
12 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Presence of permanent dentition (no primary teeth remaining)
* Non-extraction orthodontic treatment plan
* Age between 12 and 30 years
* Mild to moderate dental crowding (0-6 mm)
* Skeletal Class I classification (ANB: 2±2°)
* Normal vertical growth direction (Sn-GoGn: 32±6°)
* No congenital tooth agenesis (excluding third molars)
* No atypical tooth shapes
* No extracted permanent teeth
* No dental caries
* Good oral hygiene
* Healthy periodontal tissues
Exclusion Criteria:
* Presence of craniofacial anomalies
* Systemic disease or condition
* Previous fixed orthodontic treatment
* History of allergy to dental materials
* History of xerostomia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared in-house clear aligners made directly versus indirectly with traditional fixed braces — can you explain which of these approaches you think would work best for my specific Class I malocclusion, and why?
2Since this study used the ABO-OGS scoring system to judge treatment quality, can you tell me what scores were achieved across the three groups, and how that might help us decide which method is most likely to give me the best result?
3Given that this trial is already completed, is there published data from it we could look at together to understand how in-house clear aligners actually performed compared to fixed braces in real patients?
4In-house clear aligners are made differently from commercial aligner brands — does your practice have the equipment and experience to offer this option, and would it even be appropriate for my case?
5Before considering a newer approach like in-house aligners, should we discuss whether traditional fixed appliances or a well-established commercial aligner system might be a safer or more predictable first choice for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment Quality Assessed by the American Board of Orthodontics Objective Grading System (ABO-OGS)
Timeframe: From the date of treatment initiation (attachment placement or bracket bonding) until the date of treatment completion (final day of aligner use or bracket debonding), assessed up to 13 months