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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."
A multicenter, single-blinded, randomized controlled trial will be consist of three main parts:
42 Patients will be enrolled; at the last appointment of orthodontic treatment before debonding, subjects will be assessed for the presence of good gingival health parameters using the BPE. Then the patients will have supra gingival debridement followed by an intraoral scan for lower arch; Intraoral scans will be taken for all the participants and STL files will be generated. In addition, a stone model will be made for the lower arch of the control group.
Group 1 (CAD/CAM retainers): STL files will be sent to lab. Group 2 (conventional retainers): The retainer wire will be shaped to adapt passively to the lingual surfaces of lower anterior teeth on the stone model. A silicone transfer key will be prepared to facilitate the positioning of the retainers Laboratory work: CAD/CAM Chrome cobalt retainers; will be digitally designed by the dental technician using EXOCAD software. Then, they will be 3D printed by 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.
Bonding procedures: The operators will first check the fitting and adaptation of the retainers on the teeth. After cleaning the teeth and isolate them by placement the rubber dam; 35% phosphoric acid etchant gel will be applied. Bonding agent, as the manufacturer's recommendations will be used, After completing the bonding procedure, the patient will be recalled after one week to measure the parameters of gingival health to exclude the plaque retentive fixed appliance effect. The patient will be given oral hygiene instructions and encouraged to use the interdental brush and will be advised to contact the clinician as soon as possible if they have any concerns or problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/CAM 3D Printed Chrome Cobalt Fixed Retainers group | Active Comparator | The participant will receive a fixed retainer fabricated using computer-aided design and computer-aided manufacturing (CAD/CAM) technology. The retainer will be constructed from cobalt-chromium. The CAD/CAM process involved scanning the patient's dental arch to create a digital model, which was then used to design the retainer. The retainer will be bonded to the lingual surfaces of the mandibular incisors and canines, extending from canine to canine. Participants were instructed to maintain proper oral hygiene and attend regular follow-up appointments. |
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| Stainless steel Fixed Retainer group | Active Comparator | participants will receive a fixed orthodontic retainer fabricated from a 0.0215-inch, five-stranded stainless steel wire. The retainer will be bonded to the lingual surfaces of the mandibular incisors and canines, extending from canine to canine. Participants were instructed to maintain proper oral hygiene and attend regular follow-up appointments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stainless steel fixed retainer | Device | The Stainless steel fixed orthodontic retainer is fabricated from a 0.0215-inch, five-stranded stainless steel wire |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | from 1st day of retainer insertion to the last of initial (first ) 6 months of retention |
| Measure | Description | Time Frame |
|---|---|---|
| Retainer survival | from 1st day of retainer insertion to the last of initial (first ) 6 months of retention | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiba Muhammed Abdul-Wahhab | Contact | 009647711144894 | hiba.abd2403p@codental.uobaghdad.edu.iq |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Ali Mohammed Hameed | University of Baghdad | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Baghdad - College of Dentistry | Baghdad | Baghdad Governorate | 10071 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36826880 | Background | Kumrular B, Cicek O, Dag IE, Avar B, Erener H. Evaluation of the Corrosion Resistance of Different Types of Orthodontic Fixed Retention Appliances: A Preliminary Laboratory Study. J Funct Biomater. 2023 Jan 31;14(2):81. doi: 10.3390/jfb14020081. | |
| 37786933 | Background | Cokakoglu S, Adanur-Atmaca R, Cakir M, Ozturk F. Stability and failure rate during 3 years of fixed retention: A follow-up of an randomized clinical trial on adolescents with four different lingual retainers. Orthod Craniofac Res. 2024 Apr;27(2):251-258. doi: 10.1111/ocr.12714. Epub 2023 Oct 3. |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 3D printed CAD/CAM Chrome cobalt fixed lingual retainers | Device | CAD/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 |
|
| after 3 months of retainer insertion to the last of initial (first ) 6 months of retention |
| inter-canine width | the distance between cusp tips of right and left mandibular canines in millimeters. | from 1st day of retainer insertion to the last of initial (first ) 6 months of retention |
| 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 | from 1st day of retainer insertion to the last of initial (first ) 6 months of retention |
| overjet | The horizontal distance ( in millimeters) between Maxillary incisor edge labial surface of Mandibular incisors | from 1st day of retainer insertion to the last of initial (first ) 6 months of retention |
| Overbite | The distance of maximum vertical overlap ( in millimeters) between Maxillary and Mandibular incisors in maximum intercuspation. | from 1st day of retainer insertion to the last of initial (first ) 6 months of retention |
| assessment of plaque accumulation | by using plaque- disclosing agent and painting all the surfaces of the teeth Plaque index then calculated. | after 3 months of retainer insertion to the last of initial (first ) 6 months of retention |
| Periodontal Probing Depth. | measured in mm using periodontal prob. | after 3 months of retainer insertion to the last of initial (first ) 6 months of retention |
| Bleeding on Probing | after 3 months of retainer insertion to the last of initial (first ) 6 months of retention |
| 34464438 | Background | Shim H, Foley P, Bankhead B, Kim KB. Comparative assessment of relapse and failure between CAD/CAM stainless steel and standard stainless steel fixed retainers in orthodontic retention patients. Angle Orthod. 2022 Jan 1;92(1):87-94. doi: 10.2319/121720-1015.1. |
| 35964235 | Background | Gera A, Pullisaar H, Cattaneo PM, Gera S, Vandevska-Radunovic V, Cornelis MA. Stability, survival, and patient satisfaction with CAD/CAM versus conventional multistranded fixed retainers in orthodontic patients: a 6-month follow-up of a two-centre randomized controlled clinical trial. Eur J Orthod. 2023 Feb 10;45(1):58-67. doi: 10.1093/ejo/cjac042. |
| 39445113 | Background | Alnuaimy NS, Alhuwaizi AF. A Novel 3-Dimensional Printed Nanoceramic Hybrid Resin Fixed Lingual Retainer: Characterization and Mechanical Tests. Int J Dent. 2024 Oct 15;2024:3540846. doi: 10.1155/2024/3540846. eCollection 2024. |
| Background | ISO.15841, Dentistry-Wires for Use in Orthodontics (Geneva, Switzerland: International Organization for Standardization, 2nd edition, 2014): 5-7. |
| 23112930 | Background | Baysal A, Uysal T, Gul N, Alan MB, Ramoglu SI. Comparison of three different orthodontic wires for bonded lingual retainer fabrication. Korean J Orthod. 2012 Feb;42(1):39-46. doi: 10.4041/kjod.2012.42.1.39. Epub 2012 Feb 27. |