Clinical trial NCT06837168: Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer
Official title: Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tooth Stability
Periodontal Health
Patient Satisfaction
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 42
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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."

Detailed description: A multicenter, single-blinded, randomized controlled trial will be consist of three main parts:

1. Questionnaire Survey - A cross-sectional survey will be distributed to orthodontists to assess their experience and perception of CAD/CAM retainers.
2. In Vitro Study - Laboratory tests will be performed on different diameters of CAD/CAM cobalt-chromium retainers to evaluate their mechanical properties, including tensile strength, load deflection, and shear bond strength.
3. Clinical trial to to evaluate the effectiveness of CAD/CAM retainer group in minimizing the 6month post-orthodontic treatment change in term of a Little's Irregularity Index (LII).

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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Good general health.
* Subjects had a full and normal complement of teeth in the lower labial segments.
* Teeth within the labial segments should be regularly sized and shaped.
* Subjects willing to consent to the trial.

Exclusion Criteria:

* 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.
* patients under systemic drug administration that affects oral health.
* Smokers

Primary outcomes:
measure: Evaluate the effectiveness of CAD/CAM 3D printed Chrome Cobalt fixed retainers
timeFrame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
Secondary outcomes:
measure: Retainer survival
timeFrame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
measure: Patient satisfaction
timeFrame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
measure: inter-canine width
timeFrame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
measure: The pattern of wire failure
timeFrame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
measure: overjet
timeFrame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
measure: Overbite
timeFrame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
measure: assessment of plaque accumulation
timeFrame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
measure: Periodontal Probing Depth.
timeFrame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
measure: Bleeding on Probing
timeFrame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad - College of Dentistry
Study officials:
affiliation: University of Baghdad
name: Prof. Dr. Ali Mohammed Hameed
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: ISO.15841, Dentistry-Wires for Use in Orthodontics (Geneva, Switzerland: International Organization for Standardization, 2nd edition, 2014): 5-7.
citation: 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.