Orthodontic RetainersNCT06529601
Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers.
A study testing CAD/CAM mandibular fixed retainer and Conventional mandibular fixed retainer in people with Orthodontic Retainers, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. Read more about this study
- Who is it for?
- Ages 13 to 20 years
- Conditions the study is for
- Orthodontic Retainers
- What is being tested?
- CAD/CAM mandibular fixed retainer and Conventional mandibular fixed retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2025to 1 Aug 2028
- 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 13 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
- Patients whose parents will sign the informed consent
Who cannot join
- Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
- Patients with metal allergies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Orthodontic Clinic, Division of Dentistry, Careggi University Hospital
Florence
Lorenzo Franchi, +390557945602, lorenzo.franchi@unifi.it
About this study
Official title: Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial
The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. In particular, the CAD/CAM device Keeppy patented by the company Leone SpA (Via Ponte a Quaracchi 50, Sesto Fiorentino, Florence) will be compared with the standard retainer made from a steel braided wire (Ortho FlexTech, Reliance Orthodontic Products Inc., 1540 West Thorndale Ave, Itasca, Illinois, USA).
This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.
The aim of this study is to evaluate whether the CAD/CAM retainer results in fewer failures (fractures or detachments) over a period of 6 months and 2 years compared to the standard retainer. In addition, the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer. Other objectives consist of the patient's assessment of pain, difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector.
- Conditions
- Orthodontic Retainers
- Being tested
- CAD/CAM mandibular fixed retainer, Conventional mandibular fixed retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD/CAM mandibular fixed retainerDevice
Also called Keeppy
Keeppy is a Class IIa custom-made medical device manufactured by Digital Service Leone s.r.l. - via Pratese 160/b, Florence, Italy. The Keeppy is an individualized fixed retainer, made of a Nickel-free Chrome Cobalt alloy, produced with a CAD-CAM procedure starting from a digital impression made with an intraoral optical scanner (3 Shape), which allows a perfect adaptation to the lingual surfaces of the 6 lower anterior teeth on which it is bonded. The device is characterized by the presence of applicators that can be placed temporarily on the buccal surface of the canines, which facilitate the clinician in the precise application of the device and which are removed as soon as the bonding phase of the retainer is complete. Bonding is performed using classic composite resins following a preparation phase of the lingual surface of the tooth consisting of the application of etchant (37% orthophosphoric acid) for 30 seconds and adhesive (primer-bonding).
Conventional mandibular fixed retainerDevice
The standard control device, which is among the most commonly used in routine clinical practice, consists of a steel braided wire. The device selected for the Class IIa investigation is the Ortho Flex Tech manufactured by Reliance Orthodontic Products, Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA. The Ortho Flex Tech steel braided wire is manually shaped by the clinician and cut with a wire cutter so that it has the proper length to extend over the 6 dental elements. Once the correct length has been defined, it is then held in place on the lingual surface of the teeth by the use of 2 interdental wires passing doubly through the interdental area (between the lateral incisor and canine on one side and the other). This allows the device to be bonded using composite resin after etching the lingual surfaces of the lower anterior teeth.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM mandibular fixed retainer | Experimental | Not described Receives: Device: CAD/CAM mandibular fixed retainer |
| Conventional mandibular fixed retainer | Active comparator | Not described Receives: Device: Conventional mandibular fixed retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retainer failure at 6-month and 2-year follow-ups
The primary endpoint is retainer failures at 6-month and 2-year follow-ups. Failure is defined as any complication requiring a retainer repair, in particular total or partial detachment and total or partial fracture.
Measured: At 6 months and at 2 years
Secondary outcomes (5)
Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
Measured: At baseline, at 6 months and at 2 years
Pain reported by patients
Pain measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean worse pain.
Measured: At baseline, at one month, at 6 months and at 2 years
Difficulty in speaking reported by patients
Difficulty in speaking measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean worse difficulty in speaking.
Measured: At baseline, at one month, at 6 months and at 2 years
Aesthetic satisfaction reported by patients
Aesthetic satisfaction measured through Visual Analogue Scale (VAS) with minimum value of 0 and maximum value of 10. Higher scores mean higher aesthetic satisfaction.
Measured: At baseline, at one month, at 6 months and at 2 years
Stability of the alignment of the lower anterior teeth
Stability of the alignment of the lower anterior teeth will be assessed with Little's irregularity index and the intercanine diameter measured on the virtual impression of the patient's teeth.
Measured: At 6 months and at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start12 Feb 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic RetainersStudies 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
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529601
- Sponsor's protocol ID
- LF15
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between CAD/CAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06529601
- Acronym / sponsor ID
- LF15
- Conditions
- Orthodontic Retainers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 31 Jul 2024 (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.
The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. In particular, the CAD/CAM device Keeppy patented by the company Leone SpA (Via Ponte a Quaracchi 50, Sesto Fiorentino, Florence) will be compared with the standard retainer made from a steel braided wire (Ortho FlexTech, Reliance Orthodontic Products Inc., 1540 West Thorndale Ave, Itasca, Illinois, USA).
This is a single-center, national, controlled, superiority, randomized, crossover, open-label study.
The aim of this study is to evaluate whether the CAD/CAM retainer results in fewer failures (fractures or detachments) over a period of 6 months and 2 years compared to the standard retainer. In addition, the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer. Other objectives consist of the patient's assessment of pain, difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM mandibular fixed retainer | Experimental | Device: CAD/CAM mandibular fixed retainer |
| Conventional mandibular fixed retainer | Active comparator | Device: Conventional mandibular fixed retainer |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;
- Patients whose parents will sign the informed consent
Key exclusion criteria (2 listed)
- Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth
- Patients with metal allergies.
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 |
|---|---|---|
| CAD/CAM mandibular fixed retainerAlso: KeeppyKeeppy is a Class IIa custom-made medical device manufactured by Digital Service Leone s.r.l. - via Pratese 160/b, Florence, Italy. The Keeppy is an individualized fixed retainer, made of a Nickel-free Chrome Cobalt alloy, produced with a CAD-CAM procedure starting from a digital impression made with an intraoral optical scanner (3 Shape), which allows a perfect adaptation to the lingual surfaces of the 6 lower anterior teeth on which it is bonded. The device is characterized by the presence of applicators that can be placed temporarily on the buccal surface of the canines, which facilitate the clinician in the precise application of the device and which are removed as soon as the bonding phase of the retainer is complete. Bonding is performed using classic composite resins following a preparation phase of the lingual surface of the tooth consisting of the application of etchant (37% orthophosphoric acid) for 30 seconds and adhesive (primer-bonding). | Device | CAD/CAM mandibular fixed retainer |
| Conventional mandibular fixed retainerThe standard control device, which is among the most commonly used in routine clinical practice, consists of a steel braided wire. The device selected for the Class IIa investigation is the Ortho Flex Tech manufactured by Reliance Orthodontic Products, Inc. 1540 West Thorndale Ave. Itasca, IL 60143 USA. The Ortho Flex Tech steel braided wire is manually shaped by the clinician and cut with a wire cutter so that it has the proper length to extend over the 6 dental elements. Once the correct length has been defined, it is then held in place on the lingual surface of the teeth by the use of 2 interdental wires passing doubly through the interdental area (between the lateral incisor and canine on one side and the other). This allows the device to be bonded using composite resin after etching the lingual surfaces of the lower anterior teeth. | Device | Conventional mandibular fixed retainer |
Primary outcome
Retainer failure at 6-month and 2-year follow-ups
Time frame: At 6 months and at 2 years
The primary endpoint is retainer failures at 6-month and 2-year follow-ups. Failure is defined as any complication requiring a retainer repair, in particular total or partial detachment and total or partial fracture.
5 secondary outcomes
Assessment of the plaque and gingival bleeding index at the central and lateral incisors and lower canines.
Time frame: At baseline, at 6 months and at 2 years
Pain reported by patients
Time frame: At baseline, at one month, at 6 months and at 2 years
Difficulty in speaking reported by patients
Time frame: At baseline, at one month, at 6 months and at 2 years
Aesthetic satisfaction reported by patients
Time frame: At baseline, at one month, at 6 months and at 2 years
Stability of the alignment of the lower anterior teeth
Time frame: At 6 months and at 2 years
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 9 Jul 2026.
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Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
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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.
Orthodontic Clinic, Division of Dentistry, Careggi University Hospital
Florence, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD/CAM mandibular fixed retainer and Conventional mandibular fixed retainer in people with Orthodontic Retainers, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retainer failure at 6-month and 2-year follow-ups (time frame: At 6 months and at 2 years). 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 9 Jul 2026.