Tooth StabilityNCT06837168
Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer
A study testing Stainless steel fixed retainer and 3D printed CAD/CAM Chrome cobalt fixed lingual retainers in people with Tooth Stability and Periodontal Health, run by University of Baghdad at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Tooth Stability, Periodontal Health, Patient Satisfaction
- What is being tested?
- Stainless steel fixed retainer and 3D printed CAD/CAM Chrome cobalt fixed lingual retainers
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site
University of Baghdad - College of Dentistry
Baghdad, Baghdad Governorate, 10071
University of Baghdad - College of Dentistry, 009647519962021, master@codental.uobaghdad.edu.iq
Prof. Dr. Ali Mohammed Hameed
About this study
Official title: Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer: a Randomized Clinical 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."
Read the detailed description
A multicenter, single-blinded, randomized controlled trial will be consist of three main parts:
- Questionnaire Survey - A cross-sectional survey will be distributed to orthodontists to assess their experience and perception of CAD/CAM retainers.
- 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.
- 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.
- Conditions
- Tooth Stability, Periodontal Health, Patient Satisfaction
- Being tested
- Stainless steel fixed retainer, 3D printed CAD/CAM Chrome cobalt fixed lingual retainers
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stainless steel fixed retainerDevice
The 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 retainersDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Stainless steel fixed retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
Secondary outcomes (9)
Retainer survival
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
Bleeding on Probing
Measured: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tooth StabilityStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba Muhammed, University of Baghdad
- Investigators
- Prof. Dr. Ali Mohammed Hameed, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837168
- Sponsor's protocol ID
- 1021425
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36826880Cokakoglu 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.
PubMed 37786933Shim 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.
PubMed 34464438Gera 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.
PubMed 35964235Alnuaimy 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.
PubMed 39445113ISO.15841, Dentistry-Wires for Use in Orthodontics (Geneva, Switzerland: International Organization for Standardization, 2nd edition, 2014): 5-7.
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.
PubMed 23112930
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Cobalt Chromium CAD-CAM Designed Customized Lingual Retainer: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06837168
- Acronym / sponsor ID
- 1021425
- Conditions
- Tooth Stability, Periodontal Health, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Questionnaire Survey - A cross-sectional survey will be distributed to orthodontists to assess their experience and perception of CAD/CAM retainers.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM 3D Printed Chrome Cobalt Fixed Retainers group | Active comparator | Device: 3D printed CAD/CAM Chrome cobalt fixed lingual retainersThe 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. |
| Stainless steel Fixed Retainer group | Active comparator | Device: Stainless steel fixed retainerparticipants 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. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stainless steel fixed retainerThe Stainless steel fixed orthodontic retainer is fabricated from a 0.0215-inch, five-stranded stainless steel wire | Device | Stainless steel Fixed Retainer group |
| 3D printed CAD/CAM Chrome cobalt fixed lingual retainersCAD/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 | Device | CAD/CAM 3D Printed Chrome Cobalt Fixed Retainers group |
Primary outcome
Evaluate the effectiveness of CAD/CAM 3D printed Chrome Cobalt fixed retainers
Time frame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
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.
9 secondary outcomes
Retainer survival
Time frame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
Patient satisfaction
Time frame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
inter-canine width
Time frame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
The pattern of wire failure
Time frame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
overjet
Time frame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
Overbite
Time frame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention
assessment of plaque accumulation
Time frame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
Periodontal Probing Depth.
Time frame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
Bleeding on Probing
Time frame: after 3 months of retainer insertion to the last of initial (first ) 6 months of retention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 36826880Kumrular 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.
- Background: PubMed 37786933Cokakoglu 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.
- Background: PubMed 34464438Shim 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.
- Background: PubMed 35964235Gera 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.
- Background: PubMed 39445113Alnuaimy 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.
- BackgroundISO.15841, Dentistry-Wires for Use in Orthodontics (Geneva, Switzerland: International Organization for Standardization, 2nd edition, 2014): 5-7.
- Background: PubMed 23112930Baysal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. Dr. Ali Mohammed Hameed study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stainless steel fixed retainer and 3D printed CAD/CAM Chrome cobalt fixed lingual retainers in people with Tooth Stability and Periodontal Health, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hiba Muhammed Abdul-Wahhab (009647711144894, hiba.abd2403p@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of CAD/CAM 3D printed Chrome Cobalt fixed retainers (time frame: from 1st day of retainer insertion to the last of initial (first ) 6 months of retention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06837168, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.