Fixed Orthodontic RetainerNCT07414264
Ultrasonographic Evaluation of Periodontal Effects of Fixed Retainers
An observational study of Fixed Orthodontic Retainer, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study aims to evaluate the effects of fixed lingual retainers placed after orthodontic treatment on periodontal soft and hard tissue parameters using ultrasonographic imaging. Read more about this study
- Who is it for?
- Ages 16 to 24 years
- Conditions the study is for
- Fixed Orthodontic Retainer
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 9 Oct 2025
- 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 16 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consisted of individuals who had completed fixed orthodontic treatment at the Department of Orthodontics, Selçuk University Faculty of Dentistry. All participants were systemically healthy, non-smoking young adults aged between 16 and 24 years, with good oral hygiene and no active periodontal disease. Each subject had maxillary and/or mandibular anterior teeth bonded with fixed retainers in passive condition. A total of 53 individuals (636 anterior teeth) were evaluated and categorized into four subgroups according to the inclination of anterior teeth: maxillary retroclination, maxillary proclination, mandibular retroclination, and mandibular proclination.
Who may be able to join
- Patients who have completed comprehensive orthodontic treatment with fixed appliances.
- Patients with a fixed mandibular or maxillary lingual retainer in place for at least 6 months.
- Age between 18 and 40 years.
- Good general health with no systemic conditions affecting periodontal tissues.
- Non-smokers or light smokers (<5 cigarettes/day).
- Presence of all anterior teeth without significant restorations or prosthetic crowns.
Who cannot join
- History of periodontal surgery or advanced periodontitis prior to orthodontic treatment.
- Systemic diseases or medications affecting periodontal health (e.g., diabetes, immunosuppressive therapy).
- Pregnancy or lactation.
- Poor oral hygiene or non-compliance with oral hygiene instructions.
- Teeth with caries, large restorations, or endodontic treatment in the area of interest.
- Patients with removable retainers or interrupted use of fixed retainers.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Faculty of Dentistry
Konya, Selçuklu, 42060
About this study
Official title: Ultrasonographic Analysis of the Effects of Fixed Lingual Retainer Placed After Orthodontic Treatment on Periodontal Parameters
This prospective clinical study aims to evaluate the effects of fixed lingual retainers placed after orthodontic treatment on periodontal soft and hard tissue parameters using ultrasonographic imaging. A total of 53 participants (636 anterior teeth) who had completed fixed orthodontic therapy were examined at baseline, 3 months, and 6 months after retainer placement. Ultrasonographic assessments were performed to measure gingival thickness, marginal bone level, and gingival level. Periodontal clinical parameters, including plaque index, gingival index, probing depth, bleeding on probing, and clinical attachment loss, were also recorded. The study seeks to determine whether fixed retainers induce measurable alterations in periodontal structures and to explore potential correlations between gingival phenotype and ultrasonographic findings.
Read the detailed description
Orthodontic retention is a critical phase following active treatment, aiming to maintain the corrected tooth positions and ensure long-term stability. Fixed lingual retainers are widely used due to their minimal patient compliance requirements and aesthetic advantages. However, the long-term presence of fixed retainers may influence periodontal health by altering plaque accumulation patterns and modifying soft and hard tissue dynamics. The literature remains inconclusive regarding whether these appliances cause clinically significant periodontal changes.
This prospective observational clinical study was conducted to evaluate the ultrasonographic and clinical periodontal changes that occur following the placement of fixed lingual retainers in orthodontically treated individuals. Fifty-three participants (aged 16-24 years) who had completed fixed orthodontic treatment were enrolled. All participants received fixed stainless-steel lingual retainers bonded to the anterior teeth (canine-to-canine) in both maxillary and mandibular arches. Participants were divided into four subgroups according to post-treatment incisor inclination changes determined by cephalometric analysis: Maxillary Retroclination, Maxillary Proclination, Mandibular Retroclination, and Mandibular Proclination groups.
Ultrasonographic imaging was performed using a high-frequency intraoral probe with a custom-designed silicone stabilizing cap to ensure consistent contact with the gingival tissue. Measurements were taken perpendicular to the tooth surface at three time points: immediately after retainer placement (T0), three months (T1), and six months (T2). The following ultrasonographic parameters were recorded:
Gingival thickness (GT)
Marginal bone level (MBL)
Gingival level (GL)
Conventional periodontal indices were also assessed at each visit, including the Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), Bleeding on Probing (BOP), and Clinical Attachment Loss (CAL). Gingival phenotype classification was determined based on gingival thickness and keratinized tissue width.
The main objective of this study is to determine whether fixed lingual retainers induce measurable changes in gingival or bone morphology as assessed by ultrasonography and to evaluate the relationship between periodontal phenotypes and ultrasonographic findings. The study also aims to contribute to the validation of ultrasonography as a noninvasive, radiation-free diagnostic method for longitudinal monitoring of periodontal tissue dynamics following orthodontic retention.
- Conditions
- Fixed Orthodontic Retainer
- Keywords
- Fixed Lingual Retainer, Orthodontic Retention, Ultrasonography, Gingival Thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. Maxillary Retroclination Group | Participants with completed fixed orthodontic treatment presenting retroclined maxillary anterior teeth. This group represents patients whose upper incisors show a lingual inclination relative to the Sella-Nasion (SN) plane. Periodontal and ultrasound (USG) parameters are evaluated at baseline, 3 months, and 6 months following retention. | |
| 2. Maxillary Proclination Group | Participants with completed fixed orthodontic treatment showing proclined maxillary anterior teeth. The upper incisors present a labial inclination relative to the SN plane. Periodontal and ultrasound (USG) parameters are compared across time intervals during retention. | |
| 3. Mandibular Retroclination Group | Participants with completed fixed orthodontic treatment and retroclined mandibular anterior teeth. The lower incisors exhibit lingual inclination relative to the mandibular plane. Periodontal and ultrasound (USG) parameters are longitudinally monitored during retention. | |
| Mandibular Proclination Group | Participants with completed fixed orthodontic treatment presenting proclined mandibular anterior teeth. The lower incisors display labial inclination relative to the mandibular plane. Periodontal and ultrasound (USG) measurements are performed at baseline, 3-month, and 6-month follow-ups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Thickness Measured by Ultrasonography
Gingival thickness will be measured at baseline (T0), 3 months (T1), and 6 months (T2) after placement of fixed lingual retainers using high-frequency intraoral ultrasonography.
Measurements will be performed at the mid-facial aspect of anterior teeth, perpendicular to the long axis of the tooth, through a customized silicone probe cap to ensure consistent contact and accuracy.
The primary outcome is the mean change in gingival thickness (in millimeters) between baseline and 6-month evaluations, reflecting potential soft tissue alterations associated with fixed lingual retainers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start24 Oct 2024
- Primary completion4 Aug 2025
- Study completion9 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fixed Orthodontic RetainerStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, metehan özdemir, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414264
- Sponsor's protocol ID
- SelcukU-DHF-MO-01
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozdemir M, Aydindogan S, Ileri Z. Clinical and ultrasonographic assessment of periodontal tissue response during the early fixed-retention phase: A prospective cohort study. Clin Oral Investig. 2026 Oct 17;30(11):535. doi: 10.1007/s00784-026-07225-8.
PubMed 42891729
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Analysis of the Effects of Fixed Lingual Retainer Placed After Orthodontic Treatment on Periodontal Parameters
- ClinicalTrials.gov ID
- NCT07414264
- Acronym / sponsor ID
- SelcukU-DHF-MO-01
- Conditions
- Fixed Orthodontic Retainer
- Keywords
- Fixed Lingual Retainer, Orthodontic Retention, Ultrasonography, Gingival Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 9 Oct 2025 (actual)
- First posted
- 17 Feb 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 prospective clinical study aims to evaluate the effects of fixed lingual retainers placed after orthodontic treatment on periodontal soft and hard tissue parameters using ultrasonographic imaging. A total of 53 participants (636 anterior teeth) who had completed fixed orthodontic therapy were examined at baseline, 3 months, and 6 months after retainer placement. Ultrasonographic assessments were performed to measure gingival thickness, marginal bone level, and gingival level. Periodontal clinical parameters, including plaque index, gingival index, probing depth, bleeding on probing, and clinical attachment loss, were also recorded. The study seeks to determine whether fixed retainers induce measurable alterations in periodontal structures and to explore potential correlations between gingival phenotype and ultrasonographic findings.
Detailed description
Orthodontic retention is a critical phase following active treatment, aiming to maintain the corrected tooth positions and ensure long-term stability. Fixed lingual retainers are widely used due to their minimal patient compliance requirements and aesthetic advantages. However, the long-term presence of fixed retainers may influence periodontal health by altering plaque accumulation patterns and modifying soft and hard tissue dynamics. The literature remains inconclusive regarding whether these appliances cause clinically significant periodontal changes.
This prospective observational clinical study was conducted to evaluate the ultrasonographic and clinical periodontal changes that occur following the placement of fixed lingual retainers in orthodontically treated individuals. Fifty-three participants (aged 16-24 years) who had completed fixed orthodontic treatment were enrolled. All participants received fixed stainless-steel lingual retainers bonded to the anterior teeth (canine-to-canine) in both maxillary and mandibular arches. Participants were divided into four subgroups according to post-treatment incisor inclination changes determined by cephalometric analysis: Maxillary Retroclination, Maxillary Proclination, Mandibular Retroclination, and Mandibular Proclination groups.
Ultrasonographic imaging was performed using a high-frequency intraoral probe with a custom-designed silicone stabilizing cap to ensure consistent contact with the gingival tissue. Measurements were taken perpendicular to the tooth surface at three time points: immediately after retainer placement (T0), three months (T1), and six months (T2). The following ultrasonographic parameters were recorded:
Gingival thickness (GT)
Marginal bone level (MBL)
Gingival level (GL)
Conventional periodontal indices were also assessed at each visit, including the Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), Bleeding on Probing (BOP), and Clinical Attachment Loss (CAL). Gingival phenotype classification was determined based on gingival thickness and keratinized tissue width.
The main objective of this study is to determine whether fixed lingual retainers induce measurable changes in gingival or bone morphology as assessed by ultrasonography and to evaluate the relationship between periodontal phenotypes and ultrasonographic findings. The study also aims to contribute to the validation of ultrasonography as a noninvasive, radiation-free diagnostic method for longitudinal monitoring of periodontal tissue dynamics following orthodontic retention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. Maxillary Retroclination Group | – | –Participants with completed fixed orthodontic treatment presenting retroclined maxillary anterior teeth. This group represents patients whose upper incisors show a lingual inclination relative to the Sella-Nasion (SN) plane. Periodontal and ultrasound (USG) parameters are evaluated at baseline, 3 months, and 6 months following retention. |
| 2. Maxillary Proclination Group | – | –Participants with completed fixed orthodontic treatment showing proclined maxillary anterior teeth. The upper incisors present a labial inclination relative to the SN plane. Periodontal and ultrasound (USG) parameters are compared across time intervals during retention. |
| 3. Mandibular Retroclination Group | – | –Participants with completed fixed orthodontic treatment and retroclined mandibular anterior teeth. The lower incisors exhibit lingual inclination relative to the mandibular plane. Periodontal and ultrasound (USG) parameters are longitudinally monitored during retention. |
| Mandibular Proclination Group | – | –Participants with completed fixed orthodontic treatment presenting proclined mandibular anterior teeth. The lower incisors display labial inclination relative to the mandibular plane. Periodontal and ultrasound (USG) measurements are performed at baseline, 3-month, and 6-month follow-ups. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of individuals who had completed fixed orthodontic treatment at the Department of Orthodontics, Selçuk University Faculty of Dentistry. All participants were systemically healthy, non-smoking young adults aged between 16 and 24 years, with good oral hygiene and no active periodontal disease. Each subject had maxillary and/or mandibular anterior teeth bonded with fixed retainers in passive condition. A total of 53 individuals (636 anterior teeth) were evaluated and categorized into four subgroups according to the inclination of anterior teeth: maxillary retroclination, maxillary proclination, mandibular retroclination, and mandibular proclination.
Key inclusion criteria (6 listed)
- Patients who have completed comprehensive orthodontic treatment with fixed appliances.
- Patients with a fixed mandibular or maxillary lingual retainer in place for at least 6 months.
- Age between 18 and 40 years.
- Good general health with no systemic conditions affecting periodontal tissues.
- Non-smokers or light smokers (<5 cigarettes/day).
Key exclusion criteria (6 listed)
- History of periodontal surgery or advanced periodontitis prior to orthodontic treatment.
- Systemic diseases or medications affecting periodontal health (e.g., diabetes, immunosuppressive therapy).
- Pregnancy or lactation.
- Poor oral hygiene or non-compliance with oral hygiene instructions.
- Teeth with caries, large restorations, or endodontic treatment in the area of interest.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Gingival Thickness Measured by Ultrasonography
Time frame: 6 months
Gingival thickness will be measured at baseline (T0), 3 months (T1), and 6 months (T2) after placement of fixed lingual retainers using high-frequency intraoral ultrasonography. Measurements will be performed at the mid-facial aspect of anterior teeth, perpendicular to the long axis of the tooth, through a customized silicone probe cap to ensure consistent contact and accuracy. The primary outcome is the mean change in gingival thickness (in millimeters) between baseline and 6-month evaluations, reflecting potential soft tissue alterations associated with fixed lingual retainers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 42891729Ozdemir M, Aydindogan S, Ileri Z. Clinical and ultrasonographic assessment of periodontal tissue response during the early fixed-retention phase: A prospective cohort study. Clin Oral Investig. 2026 Oct 17;30(11):535. doi: 10.1007/s00784-026-07225-8.
- 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. 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 Fixed Orthodontic Retainer, run by Selcuk 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 6 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: finished, as of the sponsor's last update on 17 Feb 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Gingival Thickness Measured by Ultrasonography (time frame: 6 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 NCT07414264, which also lists 1 linked publication.
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 17 Feb 2026.