Relapse Clinical Trial
— RetentionOfficial title:
CAD/CAM Fixed Retainers vs. Conventional Multistranded Fixed Retainers in Orthodontic Patients. Comparison of Stability, Retainer Failure Rate, Adverse Effects, Cost-effectiveness, and Patient Satisfaction. A Randomized Controlled Clinical Trial.
Verified date | November 2022 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction: Orthodontic retainers are used after the completion of orthodontic treatment to assure dental occlusal stability and to maintain the achieved end-result. However, without retention teeth could go back to their initial dental malposition or could even take a different unpredicted position resulting once again in dental malocclusion (a deviation from normal occlusion). There are different types of retainers, some are fixed (glued to the back of the front teeth), and others are removable (can be removed and replaced into the mouth by the patient). While there are various retainers used for retention (stability), there is no perfect method. Fixed retainers (FRs) are used worldwide. On the one hand, FRs focus on preventing relapse. On the other hand, there are sometimes some adverse effects of retainers; they could fail at a certain point (break/get loose), or cause unwanted tooth movements. Until now, the choice of a retention method is based solely on clinicians' experience as there is no substantial evidence regarding the best retention method or the duration of the retention period. Some clinicians prolong the retention period while others prefer to keep the retainers for an indefinite time. As the world is advancing, so is the orthodontic science. New FR fabricated by CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), are assumed to have greater accuracy, better fit, and most importantly, might offer a passive positioning of the retainer. However, the evidence about CAD/CAM FRs is very limited. Purpose: To investigate and compare the clinical effectiveness of two types of FRs; CAD/CAM vs. multistranded wire, in terms of stability (primary outcome), failure rate, adverse effects, cost-effectiveness, and patient satisfaction (secondary outcomes), substantial up to 5 years after retainer placement. Hypotheses: Compared to traditional multistranded FRs, CAD/CAM FRs have: - Better long term stability, - Similar failure rate, - Fewer adverse effects, - Similar cost-effectiveness and patient satisfaction.
Status | Active, not recruiting |
Enrollment | 126 |
Est. completion date | December 2025 |
Est. primary completion date | November 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. Healthy patients. 2. Age: 12-25 years old (at time of debonding). 3. Presence of all maxillary and mandibular anterior teeth, with normal shape and size. 4. Completion of a course of fixed appliance therapy involving both dental arches. 5. Subjects willing to consent to the trial and comply with the trial regime. No restriction to presenting initial malocclusion, type of active orthodontic treatment undertaken provided that it included full fixed appliances (functional/removable appliances in combination with fixed appliances - extraction or non-extraction) Exclusion Criteria: 1. Patients with cleft lip or palate, or both or any other craniofacial syndrome. 2. Patients who had surgical correction of the jaws: Le fort I (2- or 3-piece maxilla) or SARPE (surgically assisted rapid palatal expansion). 3. Lingual appliance treatments. 4. Periodontal disease. 5. Hypoplasia of enamel. 6. Fluorosis. 7. Active caries, restorations or fractures in the anterior teeth. 8. Patients who have had separate debonding appointments for each jaw, with a difference of more than 2 months in between. 9. Re-treated patients. |
Country | Name | City | State |
---|---|---|---|
Denmark | Marie Anne Michele Cornelis | Aarhus | |
Norway | University of Oslo | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | University of Oslo |
Denmark, Norway,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stability | Change in lower incisor crowding will be assessed using Little's Irregularity Index (LII). Change in overall occlusal stability will be assessed by the Peer Assessment Rating (PAR) index. In addition, changes in arch dimensions, occlusal relationships, and re-opening of extraction spaces will be recorded. | From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively) | |
Secondary | Failure rate and survival time | Calculated from the first day of retainer's bonding to the day of the first failure episode | From the time of retainer bonding to the first failure episode: From debonding, and up to 60 months later | |
Secondary | Adverse effects | Screen for unexpected posttreatment changes in the mandibular anterior region associated with the use of both types of fixed retainers | From debonding, and up to 60 months later | |
Secondary | Cost-effectiveness | Unit costs in euros (€) will be used to value the resources included | From debonding, and up to 60 months later | |
Secondary | Patient satisfaction | Visual Analogue Scale (VAS) | From debonding, and after 1, 6 and 12 months in retention phase |
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