Effect of Lingual Retainers on Tooth StabilityNCT06284499
Effect of Different Fixed Lingual Retainers on Tooth Stability
An observational study of Effect of Lingual Retainers on Tooth Stability, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device. Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower… Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Lingual Retainers on Tooth Stability
- What is being tested?
- measuring tooth stability after orthodontic treatment using a Periotest® device.
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jan 2020to 13 Oct 2023
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients seeking orthodontic treatment in an university hospital
Who may be able to join
- Successful completion of orthodontic treatment with optimum oral hygiene
- A duration of orthodontic treatment with fixed appliances of more than 12 months
- No missing teeth, restorations, or morphological crown anomalies
- No radiological alveolar bone loss in the mandibular inter-canine region.
Who cannot join
- Individuals with periodontal problems, such as gingival bleeding and recession, parafunctional habits (e.g., clenching and grinding),
- Any radiological pathology around the lower anterior teeth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University, Faculty of Dentistry
Hatay, 31060
About this study
Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.
Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests.
- Being tested
- measuring tooth stability after orthodontic treatment using a Periotest® device.
- Keywords
- Mobility, Lingual Retainer, Retention, Periotest®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring tooth stability after orthodontic treatment using a Periotest® device.Other
The tooth mobility was determined by taking three repeat measurements from each tooth and calculating the average of these measurements, using a Periotest® device.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 (n = 31), which contained patients fitted with 0.038 × 0.016" stainless steel wire (Ortho FlexTech® chain, Reliance Orthodontic Products, Itasca, IL, USA) Receives: Other: measuring tooth stability after orthodontic treatment using a Periotest® device. | |
| Group 2 | Group 2 (n = 23), which contained patients fitted with 0.010 × 0.026" 8-braided dead soft wire (Bond-A-Braid,Reliance Orthodontic Products, Itasca, IL, USA) Receives: Other: measuring tooth stability after orthodontic treatment using a Periotest® device. | |
| Group 3 | Group 3 (n = 28), which contained patients fitted with 0.0215" 5-stranded stainless steel wire (Penta-One®, Masel Orthodontics, Carlsbad, CA, USA) Receives: Other: measuring tooth stability after orthodontic treatment using a Periotest® device. | |
| Control group | Control group (n = 20), which contained individuals who had not received any orthodontic treatment Receives: Other: measuring tooth stability after orthodontic treatment using a Periotest® device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device
Tooth mobility measured just before and after lingual retainer wire application
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start16 Jan 2020
- Primary completion15 Jan 2023
- Study completion13 Oct 2023
Why it stopped: Completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Effect of Lingual Retainers on Tooth StabilityStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Fatih Arpag, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284499
- Sponsor's protocol ID
- 26308819120
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Littlewood SJ, Kandasamy S, Huang G. Retention and relapse in clinical practice. Aust Dent J. 2017 Mar;62 Suppl 1:51-57. doi: 10.1111/adj.12475.
PubMed 28297088Bishara SE, Treder JE, Damon P, Olsen M. Changes in the dental arches and dentition between 25 and 45 years of age. Angle Orthod. 1996;66(6):417-22. doi: 10.1043/0003-3219(1996)0662.3.CO;2.
PubMed 8974177Johnston CD, Littlewood SJ. Retention in orthodontics. Br Dent J. 2015 Feb 16;218(3):119-22. doi: 10.1038/sj.bdj.2015.47.
PubMed 25686428Golshah A, Feyli SA. Bond Strength and Deflection of Four Types of Bonded Lingual Retainers. Int J Dent. 2022 Feb 24;2022:1707520. doi: 10.1155/2022/1707520. eCollection 2022.
PubMed 35251180Kucera J, Marek I, Littlewood SJ. The effect of different bonded retainer wires on tooth mobility immediately after orthodontic treatment. Eur J Orthod. 2022 Mar 30;44(2):178-186. doi: 10.1093/ejo/cjab038.
PubMed 34374751Kucuk EB, Celik Guler O, Fatih Arpag O, Eren HK. Effect of different fixed lingual retainers on tooth mobility: prospective clinical study. Acta Odontol Scand. 2025 Dec 10;84:577-582. doi: 10.2340/aos.v84.44808.
PubMed 41369988
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Fixed Lingual Retainers on Tooth Stability
- ClinicalTrials.gov ID
- NCT06284499
- Acronym / sponsor ID
- 26308819120
- Keywords
- Mobility, Lingual Retainer, Retention, Periotest®
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Completed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 29 Feb 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.
Objective: The aim of this study was to compare the effect of different fixed lingual retainers (LRs) on tooth stability after orthodontic treatment using a Periotest® device.
Materials and methods: A total of 82 patients (43 females and 39 males; mean age = 18.61 ± 3.71 years) with no missing teeth in the lower inter-canine region were treated with fixed orthodontic mechanics. At the completion of the orthodontic treatment, each patient was fitted with either Ortho FlexTech (Reliance; Group I), dead soft 8-braided (Bond-A-Braid, Reliance; Group II), or 5-stranded (PentaOne, Masel; Group III) LR wire. A control group consisting of people with a healthy periodontal condition and no bone loss was included (Control; Group C). The mobility of the lower anterior teeth on the right and left sides was measured using a Periotest® device before (T0), immediately after (T1), and 10 months after (T2) the application of the LR. Statistical analyses were performed using one-way ANOVA followed by post hoc LSD, repeated ANOVA with Bonferroni post hoc test, and Pearson χ2 tests.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: measuring tooth stability after orthodontic treatment using a Periotest® device.Group 1 (n = 31), which contained patients fitted with 0.038 × 0.016" stainless steel wire (Ortho FlexTech® chain, Reliance Orthodontic Products, Itasca, IL, USA) |
| Group 2 | – | Other: measuring tooth stability after orthodontic treatment using a Periotest® device.Group 2 (n = 23), which contained patients fitted with 0.010 × 0.026" 8-braided dead soft wire (Bond-A-Braid,Reliance Orthodontic Products, Itasca, IL, USA) |
| Group 3 | – | Other: measuring tooth stability after orthodontic treatment using a Periotest® device.Group 3 (n = 28), which contained patients fitted with 0.0215" 5-stranded stainless steel wire (Penta-One®, Masel Orthodontics, Carlsbad, CA, USA) |
| Control group | – | Other: measuring tooth stability after orthodontic treatment using a Periotest® device.Control group (n = 20), which contained individuals who had not received any orthodontic treatment |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients seeking orthodontic treatment in an university hospital
Key inclusion criteria (4 listed)
- Successful completion of orthodontic treatment with optimum oral hygiene
- A duration of orthodontic treatment with fixed appliances of more than 12 months
- No missing teeth, restorations, or morphological crown anomalies
- No radiological alveolar bone loss in the mandibular inter-canine region.
Key exclusion criteria (2 listed)
- Individuals with periodontal problems, such as gingival bleeding and recession, parafunctional habits (e.g., clenching and grinding),
- Any radiological pathology around the lower 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 |
|---|---|---|
| measuring tooth stability after orthodontic treatment using a Periotest® device.The tooth mobility was determined by taking three repeat measurements from each tooth and calculating the average of these measurements, using a Periotest® device. | Other | Control group, Group 1, Group 2, Group 3 |
Primary outcome
Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device
Time frame: Up to 10 months
Tooth mobility measured just before and after lingual retainer wire application
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 28297088Littlewood SJ, Kandasamy S, Huang G. Retention and relapse in clinical practice. Aust Dent J. 2017 Mar;62 Suppl 1:51-57. doi: 10.1111/adj.12475.
- Background: PubMed 8974177Bishara SE, Treder JE, Damon P, Olsen M. Changes in the dental arches and dentition between 25 and 45 years of age. Angle Orthod. 1996;66(6):417-22. doi: 10.1043/0003-3219(1996)0662.3.CO;2.
- Background: PubMed 25686428Johnston CD, Littlewood SJ. Retention in orthodontics. Br Dent J. 2015 Feb 16;218(3):119-22. doi: 10.1038/sj.bdj.2015.47.
- Background: PubMed 35251180Golshah A, Feyli SA. Bond Strength and Deflection of Four Types of Bonded Lingual Retainers. Int J Dent. 2022 Feb 24;2022:1707520. doi: 10.1155/2022/1707520. eCollection 2022.
- Background: PubMed 34374751Kucera J, Marek I, Littlewood SJ. The effect of different bonded retainer wires on tooth mobility immediately after orthodontic treatment. Eur J Orthod. 2022 Mar 30;44(2):178-186. doi: 10.1093/ejo/cjab038.
- Derived from this study: PubMed 41369988Kucuk EB, Celik Guler O, Fatih Arpag O, Eren HK. Effect of different fixed lingual retainers on tooth mobility: prospective clinical study. Acta Odontol Scand. 2025 Dec 10;84:577-582. doi: 10.2340/aos.v84.44808.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effect of Lingual Retainers on Tooth Stability, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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 4 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: withdrawn, as of the sponsor's last update on 29 Feb 2024. 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 Turkey (Türkiye). 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of tooth stability after orthodontic lingual retainer wire application using periotest device (time frame: Up to 10 months). 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 NCT06284499, which also lists 6 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 29 Feb 2024.