Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer

NCT06837168 | Not Yet Recruiting DMC

• 1 other identifier: 1021425
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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."

Conditions

Tooth Stability; Periodontal Health; Patient Satisfaction

Outcome Measures

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.

  from 1st day of retainer insertion to the last of initial (first ) 6 months of retention

Secondary Outcomes (9)

• Retainer survival

  from 1st day of retainer insertion to the last of initial (first ) 6 months of retention

• Patient satisfaction

  after 3 months of retainer insertion to the last of initial (first ) 6 months of retention

• inter-canine width

  from 1st day of retainer insertion to the last of initial (first ) 6 months of retention

• The pattern of wire failure

  from 1st day of retainer insertion to the last of initial (first ) 6 months of retention

• overjet

  from 1st day of retainer insertion to the last of initial (first ) 6 months of retention

Study Arms (2)

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.

Device: 3D printed CAD/CAM Chrome cobalt fixed lingual retainers

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.

Device: Stainless steel fixed retainer

Interventions

Stainless steel fixed retainer DEVICE

The Stainless steel fixed orthodontic retainer is fabricated from a 0.0215-inch, five-stranded stainless steel wire

Stainless steel Fixed Retainer group

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

CAD/CAM 3D Printed Chrome Cobalt Fixed Retainers group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad - College of Dentistry

Baghdad, Baghdad Governorate, 10071, Iraq

Location

Related Publications (7)

• 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.

  PMID: 36826880 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.

  PMID: 37786933 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.

  PMID: 34464438 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.

  PMID: 35964235 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.

  PMID: 39445113 BACKGROUND

• ISO.15841, Dentistry-Wires for Use in Orthodontics (Geneva, Switzerland: International Organization for Standardization, 2nd edition, 2014): 5-7.

  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.

  PMID: 23112930 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Prof. Dr. Ali Mohammed Hameed

  University of Baghdad

  STUDY DIRECTOR

Central Study Contacts

Hiba Muhammed Abdul-Wahhab

CONTACT

009647711144894; hiba.abd2403p@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)