Orthodontic RelapseNCT07730476
3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
A study testing Conventional Multistranded Stainless Steel Fixed Retainer, 3D-Printed Cobalt-Chromium Fixed Retainer and 3D-Printed Titanium Fixed Retainer in people with Orthodontic Relapse and Malocclusion, run by Minia University.
Trial summary
This randomized clinical trial aims to compare the clinical performance of two types of three-dimensionally printed fixed retainers (Cobalt-Chromium and Titanium Grade 5) with the conventional multistranded stainless steel fixed retainer following orthodontic treatment. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Relapse, Malocclusion
- What is being tested?
- Conventional Multistranded Stainless Steel Fixed Retainer, 3D-Printed Cobalt-Chromium Fixed Retainer and 3D-Printed Titanium Fixed Retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Sep 2027
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range 21-35 years old after finishing orthodontic treatment.
- Presence of all maxillary and mandibular anterior teeth with normal shape and size.
- Completion of orthodontic treatment with full fixed appliances.
Who cannot join
- Patients with cleft lip and/or palate or any other craniofacial syndrome
- Patients with compromised oral hygiene or periodontal disease
- Patients who had orthognathic surgery
- Lingual appliance treatments
- Enamel hypoplasia, fluorosis, active caries, restorations, or fractures in the anterior teeth
- Patients who had separate arch debondings with a difference of more than 2 months in-between jaws
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Three-Dimensionally Printed Fixed Retainers Versus Conventional Multistranded Stainless Steel Fixed Retainers: Randomized Clinical Trial
This randomized clinical trial aims to compare the clinical performance of two types of three-dimensionally printed fixed retainers (Cobalt-Chromium and Titanium Grade 5) with the conventional multistranded stainless steel fixed retainer following orthodontic treatment. Thirty-six participants will be randomly allocated into three parallel groups with a 1:1:1 allocation ratio. The primary outcome is post-treatment stability assessed by Little's Irregularity Index and lower arch dimensions. Secondary outcomes include bond failure rate and periodontal parameters over a 12-month follow-up period.
Read the detailed description
Orthodontic relapse remains one of the greatest challenges following the completion of orthodontic treatment. Conventional multistranded stainless steel fixed retainers are considered the gold standard for long-term retention; however, they have several limitations, including operator-dependent adaptation, prolonged chairside time, structural instability, and possible unwanted tooth movement.
Advances in digital dentistry have introduced CAD/CAM technology and additive manufacturing (3D printing), enabling the fabrication of customized fixed retainers with improved adaptation and manufacturing accuracy. Three-dimensional printed retainers fabricated from Cobalt-Chromium (Co-Cr) and Titanium Grade 5 (Ti-6Al-4V) alloys may provide superior mechanical properties, greater manufacturing precision, and potentially improved clinical performance compared with conventional retainers.
- Conditions
- Orthodontic Relapse, Malocclusion
- Being tested
- Conventional Multistranded Stainless Steel Fixed Retainer, 3D-Printed Cobalt-Chromium Fixed Retainer, 3D-Printed Titanium Fixed Retainer
- Keywords
- Orthodontic retention, Fixed retainer, 3D-printed retainer, Cobalt-Chromium, Titanium, Multistranded stainless steel retainer, Randomized clinical trial, Little's Irregularity Index
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Multistranded Stainless Steel Fixed RetainerDevice
Conventional 0.0215-inch six-stranded stainless steel bonded fixed retainer.
3D-Printed Cobalt-Chromium Fixed RetainerDevice
Customized 3D-printed cobalt-chromium bonded fixed retainer fabricated from intraoral scans.
3D-Printed Titanium Fixed RetainerDevice
Customized 3D-printed titanium (Ti-6Al-4V) bonded fixed retainer fabricated from intraoral scans.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Stainless Steel Fixed Retainer | Experimental | Participants receive a conventional multistranded stainless steel fixed retainer bonded after orthodontic debonding. Receives: Device: Conventional Multistranded Stainless Steel Fixed Retainer |
| 3D-Printed Cobalt-Chromium Fixed Retainer | Experimental | Participants receive a customized 3D-printed cobalt-chromium fixed retainer bonded after orthodontic debonding Receives: Device: 3D-Printed Cobalt-Chromium Fixed Retainer |
| 3D-Printed Titanium Fixed Retainer | Experimental | Participants receive a customized 3D-printed titanium (Ti-6Al-4V) fixed retainer bonded after orthodontic debonding. Receives: Device: 3D-Printed Titanium Fixed Retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthodontic stability assessed using Little's Irregularity Index
Orthodontic stability will be assessed using Little's Irregularity Index on digital models. The Little's Irregularity Index ranges from 0 mm to higher positive values. A score of 0 mm indicates perfect alignment. Higher scores indicate greater relapse, whereas lower scores indicate better orthodontic stability.
Measured: 12 months
Secondary outcomes (5)
Retainer failure rate
Assessment of the failure rate of conventional stainless steel, 3D-printed cobalt-chromium, and 3D-printed titanium fixed retainers.
Measured: 12 months
Plaque Index (Silness and Löe Plaque Index)
Dental plaque accumulation will be assessed using the Silness and Löe Plaque Index, which is scored from 0 to 3:
0: No plaque
- A film of plaque detectable by probe
- Moderate plaque accumulation
- Abundant plaque accumulation
Lower scores indicate better oral hygiene.
Measured: 12 months
Gingival Index (Löe and Silness Gingival Index)
Gingival inflammation will be assessed using the Löe and Silness Gingival Index, which is scored from 0 to 3:
0: Normal gingiva
- Mild inflammation
- Moderate inflammation
- Severe inflammation
Lower scores indicate better gingival health.
Measured: 12 months
Bleeding on Probing (BOP)
Assessment of bleeding on probing as an indicator of gingival inflammation. Bleeding on probing will be assessed as the percentage of bleeding sites (0-100%). Lower percentages indicate better periodontal health.
Measured: 12 months
Probing Pocket Depth (PPD)
Assessment of periodontal pocket depth using a periodontal probe. Pocket depth will be recorded in millimeters (mm). Lower values indicate better periodontal health.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RelapseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio into three parallel groups to receive either a conventional multistranded stainless steel fixed retainer, a 3D-printed Cobalt-Chromium fixed retainer, or a 3D-printed Titanium Grade 5 fixed retainer.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Daabis, Minia University
- Investigators
- Salma A daabis, BDS, Principal investigator, Minia UniversityAhmed Sh Hashem, Professor, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730476
- Sponsor's protocol ID
- SDD-RCT-2026-01
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data (IPD).
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Three-Dimensionally Printed Fixed Retainers Versus Conventional Multistranded Stainless Steel Fixed Retainers: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07730476
- Acronym / sponsor ID
- SDD-RCT-2026-01
- Conditions
- Orthodontic Relapse, Malocclusion
- Keywords
- Orthodontic retention, Fixed retainer, 3D-printed retainer, Cobalt-Chromium, Titanium, Multistranded stainless steel retainer, Randomized clinical trial, Little's Irregularity Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Jul 2026 (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 randomized clinical trial aims to compare the clinical performance of two types of three-dimensionally printed fixed retainers (Cobalt-Chromium and Titanium Grade 5) with the conventional multistranded stainless steel fixed retainer following orthodontic treatment. Thirty-six participants will be randomly allocated into three parallel groups with a 1:1:1 allocation ratio. The primary outcome is post-treatment stability assessed by Little's Irregularity Index and lower arch dimensions. Secondary outcomes include bond failure rate and periodontal parameters over a 12-month follow-up period.
Detailed description
Orthodontic relapse remains one of the greatest challenges following the completion of orthodontic treatment. Conventional multistranded stainless steel fixed retainers are considered the gold standard for long-term retention; however, they have several limitations, including operator-dependent adaptation, prolonged chairside time, structural instability, and possible unwanted tooth movement.
Advances in digital dentistry have introduced CAD/CAM technology and additive manufacturing (3D printing), enabling the fabrication of customized fixed retainers with improved adaptation and manufacturing accuracy. Three-dimensional printed retainers fabricated from Cobalt-Chromium (Co-Cr) and Titanium Grade 5 (Ti-6Al-4V) alloys may provide superior mechanical properties, greater manufacturing precision, and potentially improved clinical performance compared with conventional retainers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio into three parallel groups to receive either a conventional multistranded stainless steel fixed retainer, a 3D-printed Cobalt-Chromium fixed retainer, or a 3D-printed Titanium Grade 5 fixed retainer.
| Arm | Type | Receives |
|---|---|---|
| Conventional Stainless Steel Fixed Retainer | Experimental | Device: Conventional Multistranded Stainless Steel Fixed RetainerParticipants receive a conventional multistranded stainless steel fixed retainer bonded after orthodontic debonding. |
| 3D-Printed Cobalt-Chromium Fixed Retainer | Experimental | Device: 3D-Printed Cobalt-Chromium Fixed RetainerParticipants receive a customized 3D-printed cobalt-chromium fixed retainer bonded after orthodontic debonding |
| 3D-Printed Titanium Fixed Retainer | Experimental | Device: 3D-Printed Titanium Fixed RetainerParticipants receive a customized 3D-printed titanium (Ti-6Al-4V) fixed retainer bonded after orthodontic debonding. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age range 21-35 years old after finishing orthodontic treatment.
- Presence of all maxillary and mandibular anterior teeth with normal shape and size.
- Completion of orthodontic treatment with full fixed appliances.
Key exclusion criteria (6 listed)
- Patients with cleft lip and/or palate or any other craniofacial syndrome
- Patients with compromised oral hygiene or periodontal disease
- Patients who had orthognathic surgery
- Lingual appliance treatments
- Enamel hypoplasia, fluorosis, active caries, restorations, or fractures in the anterior teeth
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 |
|---|---|---|
| Conventional Multistranded Stainless Steel Fixed RetainerConventional 0.0215-inch six-stranded stainless steel bonded fixed retainer. | Device | Conventional Stainless Steel Fixed Retainer |
| 3D-Printed Cobalt-Chromium Fixed RetainerCustomized 3D-printed cobalt-chromium bonded fixed retainer fabricated from intraoral scans. | Device | 3D-Printed Cobalt-Chromium Fixed Retainer |
| 3D-Printed Titanium Fixed RetainerCustomized 3D-printed titanium (Ti-6Al-4V) bonded fixed retainer fabricated from intraoral scans. | Device | 3D-Printed Titanium Fixed Retainer |
Primary outcome
Orthodontic stability assessed using Little's Irregularity Index
Time frame: 12 months
Orthodontic stability will be assessed using Little's Irregularity Index on digital models. The Little's Irregularity Index ranges from 0 mm to higher positive values. A score of 0 mm indicates perfect alignment. Higher scores indicate greater relapse, whereas lower scores indicate better orthodontic stability.
5 secondary outcomes
Retainer failure rate
Time frame: 12 months
Plaque Index (Silness and Löe Plaque Index)
Time frame: 12 months
Gingival Index (Löe and Silness Gingival Index)
Time frame: 12 months
Bleeding on Probing (BOP)
Time frame: 12 months
Probing Pocket Depth (PPD)
Time frame: 12 months
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 31 Jul 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data (IPD).
Related trials for Orthodontic Relapse
Not yet recruiting
Effectiveness, Patient Acceptance, and Cost Estimation of 3D-printed Retainer Compared to Hawley Retainer in Expansion Case: a Randomized Controlled Trial
Orthodontic Relapse, Retention in Orthodontic
Active, not recruiting
The Use of Remote Monitoring for Orthodontic Retention Review
Orthodontic Relapse
Recruiting
Effectiveness of Gold Fixed Retainers Compared to Conventional Stainless Steel Retainers
Orthodontic Retention Appliance, Orthodontic Relapse
Active, not recruiting
The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession
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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.
Salma A daabis, BDS principal investigator
Minia University
Ahmed Sh Hashem, Professor principal investigator
Minia University
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Multistranded Stainless Steel Fixed Retainer, 3D-Printed Cobalt-Chromium Fixed Retainer and 3D-Printed Titanium Fixed Retainer in people with Orthodontic Relapse and Malocclusion, run by Minia University.
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 3 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Salma A Daabis, BDS (+201066600270, salma.daabis@pua.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthodontic stability assessed using Little's Irregularity Index (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.