Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-25
SponsorUniversity of Baghdad
About this trial
This study aims to evaluate the clinical effectiveness of CAD/CAM 3D printed Chrome Cobalt fixed retainer in maintaining mandibular anterior teeth stability.
The Research Question; "Does the Cobalt-Chromium CAD/CAM designed customized lingual retainer better than Stainless steel lingual retainer in improving tooth stability after orthodontic treatment?" The null hypothesis "There is no differences between the fixed CAD/CAM 3D printed Chrome Cobalt customized retainer and the multi-stranded stainless-steel fixed retainer in maintaining mandibular anterior teeth stability."
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Completion of a course of fixed appliance therapy.
with a satisfactory correction of malocclusion and dental alignment.
Class I canine relationship based on Andrew's criteria for finishing.
Patients with a history of constant oral hygiene measures daily.
Disqualifiers
Patients with a deep overbite
Patients with traumatic parafunctional habits such as bruxism and clenching.
Patients with carious, restored, fractured, or missing lower anterior teeth.
Patients with medical health problems that may influence gingival health, like uncontrolled type II diabetic patients.
Trial design
Design model
Parallel
Treatments tested in this trial
Stainless steel fixed retainer
DeviceThe Stainless steel fixed orthodontic retainer is fabricated from a 0.0215-inch, five-stranded stainless steel wire
3D printed CAD/CAM Chrome cobalt fixed lingual retainers
DeviceCAD/CAM Chrome cobalt retainers; will be digitally designed by the dental technician using EXOCAD software. Then, they will be printed by DMP Flex100 metal 3D printer and then will be polished. Also, a projection like extensions will be added at the ends of the retainers to avoid slippage in addition to gingivally directed V notch shaped bend in the retainer to increase the retention in the anterior region
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: CAD/CAM 3D Printed Chrome Cobalt Fixed Retainers groupActive comparator 1 intervention
Group B: Stainless steel Fixed Retainer groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the effectiveness of CAD/CAM 3D printed Chrome Cobalt fixed retainers
Evaluate the effectiveness of CAD/CAM 3D printed Chrome Cobalt fixed retainers a in term of post-treatment stability of mandibular anterior teeth over a 6-month period by using Little's Irregularity Index. Post-treatment changes in millimeters will be defined as change in labial segment alignment.
Time frame
from 1st day of retainer insertion to the last of initial (first ) 6 months of retentionSecondary outcomes
1
Retainer survival
Time frame
from 1st day of retainer insertion to the last of initial (first ) 6 months of retention2
Patient satisfaction
the patient experience with the new retainer will be evaluated through the Visual Analogue Scale regarding comfort/satisfaction with the Fixed retainers. There will be five questions relating to how comfortable he/she finds the retainers and how they affect the daily life. Each question must be answered by number from 0 to 100; The left side represents 0 = complete satisfaction/comfort The right side represents 100 = complete discomfort/unsatisfaction
Time frame
after 3 months of retainer insertion to the last of initial (first ) 6 months of retention3
inter-canine width
the distance between cusp tips of right and left mandibular canines in millimeters.
Time frame
from 1st day of retainer insertion to the last of initial (first ) 6 months of retention4
The pattern of wire failure
The pattern of failure will be recorded: the wire-composite interface; the enamel-composite interface; wire fracture; or complete detachment from all teeth
Time frame
from 1st day of retainer insertion to the last of initial (first ) 6 months of retentionSponsors 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: