3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-35
SponsorMinia University
About this trial
This randomized clinical trial aims to compare the clinical performance of two types of three-dimensionally printed fixed retainers (Cobalt-Chromium and Titanium Grade 5) with the conventional multistranded stainless steel fixed retainer following orthodontic treatment. Thirty-six participants will be randomly allocated into three parallel groups with a 1:1:1 allocation ratio. The primary outcome is post-treatment stability assessed by Little's Irregularity Index and lower arch dimensions. Secondary outcomes include bond failure rate and periodontal parameters over a 12-month follow-up period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age range 21-35 years old after finishing orthodontic treatment.
Presence of all maxillary and mandibular anterior teeth with normal shape and size.
Completion of orthodontic treatment with full fixed appliances.
Disqualifiers
Patients with cleft lip and/or palate or any other craniofacial syndrome
Patients with compromised oral hygiene or periodontal disease
Patients who had orthognathic surgery
Lingual appliance treatments
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Multistranded Stainless Steel Fixed Retainer
DeviceConventional 0.0215-inch six-stranded stainless steel bonded fixed retainer.
3D-Printed Cobalt-Chromium Fixed Retainer
DeviceCustomized 3D-printed cobalt-chromium bonded fixed retainer fabricated from intraoral scans.
3D-Printed Titanium Fixed Retainer
DeviceCustomized 3D-printed titanium (Ti-6Al-4V) bonded fixed retainer fabricated from intraoral scans.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Conventional Stainless Steel Fixed RetainerExperimental treatment 1 intervention
Group B: 3D-Printed Cobalt-Chromium Fixed RetainerExperimental treatment 1 intervention
Group C: 3D-Printed Titanium Fixed RetainerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Orthodontic stability assessed using Little's Irregularity Index
Orthodontic stability will be assessed using Little's Irregularity Index on digital models. The Little's Irregularity Index ranges from 0 mm to higher positive values. A score of 0 mm indicates perfect alignment. Higher scores indicate greater relapse, whereas lower scores indicate better orthodontic stability.
Time frame
12 monthsSecondary outcomes
1
Retainer failure rate
Assessment of the failure rate of conventional stainless steel, 3D-printed cobalt-chromium, and 3D-printed titanium fixed retainers.
Time frame
12 months2
Plaque Index (Silness and Löe Plaque Index)
Dental plaque accumulation will be assessed using the Silness and Löe Plaque Index, which is scored from 0 to 3: 0: No plaque 1. A film of plaque detectable by probe 2. Moderate plaque accumulation 3. Abundant plaque accumulation Lower scores indicate better oral hygiene.
Time frame
12 months3
Gingival Index (Löe and Silness Gingival Index)
Gingival inflammation will be assessed using the Löe and Silness Gingival Index, which is scored from 0 to 3: 0: Normal gingiva 1. Mild inflammation 2. Moderate inflammation 3. Severe inflammation Lower scores indicate better gingival health.
Time frame
12 months4
Bleeding on Probing (BOP)
Assessment of bleeding on probing as an indicator of gingival inflammation. Bleeding on probing will be assessed as the percentage of bleeding sites (0-100%). Lower percentages indicate better periodontal health.
Time frame
12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: