Mandibular RetrognathismNCT06935032
Functional Appliance Effects on Mandibular Soft Tissues
A study testing Twin block appliance and Fixed orthodontic treatment in people with Mandibular Retrognathism, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the changes in mandibular and cervical soft tissues in Class II patients with mandibular retrognathia treated with the Twin Block appliance, compared to skeletal Class I patients without functional treatment, using profile photographs and cephalometric films. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Mandibular Retrognathism
- What is being tested?
- Twin block appliance and Fixed orthodontic treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2021to 24 Jul 2023
- Phase
- Interventional
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- having Class II malocclusion caused by mandibular retrognathia (ANB > 4°, SNB<78°),
- exhibiting horizontal and/or normal growth pattern (SN-GoGn=32 ±6),
- having profile photographs and cephalometric radiographs taken in the NHP (using the self-balance method one of the dynamic approaches for determining NHP)15,
- not requiring rapid maxillary expansion,
- not having increased initial lower incisor inclination on lateral cephalometric radiographs,
- Class II Division 2 patients presenting with ≥4 mm deepbite and the absence of any prior upper incisor protrusion methods,
- the control group individuals were required to have a skeletal Class I pattern (ANB angle between 0-4°) without any dental deficiencies.
Who cannot join
- previous orthodontic treatment,
- presence of craniofacial anomalies involving the jaw and/or teeth,
- severe facial asymmetry
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Meram, 42090
About this study
Official title: Evaluation of Mandibular Soft Tissue Changes in Patients Using Functional Appliances
This study aimed to evaluate the changes in mandibular and cervical soft tissues in Class II patients with mandibular retrognathia treated with the Twin Block appliance, compared to skeletal Class I patients without functional treatment, using profile photographs and cephalometric films. Sixteen patients with Class II Division 1, fifteen with Class II Division 2, and fifteen with skeletal Class I malocclusion were included. Measurements were performed at the beginning of treatment and after functional therapy. In the Class II Div 1 group, most parameters showed significant reductions, except for neck length and jaw tip contour. In the Class II Div 2 group, only the Sm-E plane measurement remained unchanged, while the control group showed minimal changes. Between-group comparisons indicated significant improvements in cervicomental angle, lip-jaw-throat angle, and other lower face soft tissue parameters, especially in Class II Division 1 patients. The findings suggest that Twin Block therapy effectively improves both skeletal and soft tissue profiles, with more pronounced soft tissue enhancement in Class II Division 1 cases.
Read the detailed description
This retrospective study aims to investigate the changes in the mandibular and cervical soft tissues of patients with Class II malocclusion and mandibular retrognathia treated with the Twin Block appliance. The study includes patients treated in the Department of Orthodontics, Faculty of Dentistry, XXXX University, between 2021 and 2023. Ethical approval was obtained from the relevant ethics committee (Decision No: 2023/351), and informed consent was secured from all participants and their parents.
A total of 46 individuals were included: 16 patients with Class II Division I malocclusion, 15 with Class II Division II malocclusion, and 15 control subjects with skeletal Class I malocclusion. All patients in the treatment groups were in the growth spurt phase (CVMS3-S4) and received Twin Block therapy full-time for 12 months. The control group received fixed orthodontic treatment without functional appliances.
Profile photographs and lateral cephalometric radiographs were obtained at the beginning of treatment (T1) and after 1 year of therapy (T2), using a standardized protocol in natural head position (NHP). Measurements were performed digitally using Dolphin Imaging software. The study assessed angular parameters such as the submental-facial angle, cervicomental angle, lip-jaw-throat angle, and Sm-E plane angle from photographs, as well as linear measurements from cephalometric radiographs, including throat length, jaw tip contour, soft tissue pogonion thickness, soft tissue menton thickness, and lower lip-pogonion distance.
Sample size was determined via power analysis, which indicated that 15 patients per group were sufficient to detect clinically meaningful differences. To ensure measurement reliability, cephalometric analyses were repeated, and intra-observer reliability was confirmed with an intraclass correlation coefficient (ICC) of 0.924.
Statistical analyses were conducted using R software. Paired t-tests were employed for within-group comparisons, while independent t-tests and ANOVA with Tukey's post hoc tests were used for intergroup comparisons. Mixed-effects models and chi-square tests were utilized where appropriate. A significance level of p < 0.05 was adopted for all analyses.
This study was designed to contribute to the understanding of how Twin Block functional appliance therapy influences the morphology of the mandibular and cervical soft tissues, using both photographic and radiographic assessments in a growing patient population.
- Conditions
- Mandibular Retrognathism
- Being tested
- Twin block appliance, Fixed orthodontic treatment
- Keywords
- : Functional appliances, soft tissue change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twin block applianceDevice
An appliance that facilitates forward positioning of the mandible and soft tissues
Fixed orthodontic treatmentOther
Patients undergoing orthodontic treatment with fixed appliances
| Study group | Role | What they receive |
|---|---|---|
| Class II Division I malocclusion caused by mandibular retrognathia | Experimental | Class II Division I patients treated with the Twin Block appliance Receives: Device: Twin block appliance |
| Class II Division II malocclusion caused by mandibular retrognathia | Experimental | Class II Division II patients treated with the Twin Block appliance Receives: Device: Twin block appliance |
| Skeletal Class I patients | Experimental | Class I patients who received fixed treatment Receives: Other: Fixed orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients treated with the Twin Block appliance
The changes in certain angular (degrees) and linear (millimeters) measurements may be considered favorable for the mandibular soft tissues.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start25 Nov 2021
- Primary completion28 Jun 2023
- Study completion24 Jul 2023
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 Mandibular RetrognathismStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Sağoğlu, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Seda Sağoğlu, Principal investigator, Konya Necmettin Erbaka University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935032
- Sponsor's protocol ID
- 2023/351
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malkoc S, Demir A, Uysal T, Canbuldu N. Angular photogrammetric analysis of the soft tissue facial profile of Turkish adults. Eur J Orthod. 2009 Apr;31(2):174-9. doi: 10.1093/ejo/cjn082. Epub 2008 Dec 8.
PubMed 19064675
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mandibular Soft Tissue Changes in Patients Using Functional Appliances
- ClinicalTrials.gov ID
- NCT06935032
- Acronym / sponsor ID
- 2023/351
- Conditions
- Mandibular Retrognathism
- Keywords
- : Functional appliances, soft tissue change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 24 Jul 2023 (actual)
- First posted
- 18 Apr 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 aimed to evaluate the changes in mandibular and cervical soft tissues in Class II patients with mandibular retrognathia treated with the Twin Block appliance, compared to skeletal Class I patients without functional treatment, using profile photographs and cephalometric films. Sixteen patients with Class II Division 1, fifteen with Class II Division 2, and fifteen with skeletal Class I malocclusion were included. Measurements were performed at the beginning of treatment and after functional therapy. In the Class II Div 1 group, most parameters showed significant reductions, except for neck length and jaw tip contour. In the Class II Div 2 group, only the Sm-E plane measurement remained unchanged, while the control group showed minimal changes. Between-group comparisons indicated significant improvements in cervicomental angle, lip-jaw-throat angle, and other lower face soft tissue parameters, especially in Class II Division 1 patients. The findings suggest that Twin Block therapy effectively improves both skeletal and soft tissue profiles, with more pronounced soft tissue enhancement in Class II Division 1 cases.
Detailed description
This retrospective study aims to investigate the changes in the mandibular and cervical soft tissues of patients with Class II malocclusion and mandibular retrognathia treated with the Twin Block appliance. The study includes patients treated in the Department of Orthodontics, Faculty of Dentistry, XXXX University, between 2021 and 2023. Ethical approval was obtained from the relevant ethics committee (Decision No: 2023/351), and informed consent was secured from all participants and their parents.
A total of 46 individuals were included: 16 patients with Class II Division I malocclusion, 15 with Class II Division II malocclusion, and 15 control subjects with skeletal Class I malocclusion. All patients in the treatment groups were in the growth spurt phase (CVMS3-S4) and received Twin Block therapy full-time for 12 months. The control group received fixed orthodontic treatment without functional appliances.
Profile photographs and lateral cephalometric radiographs were obtained at the beginning of treatment (T1) and after 1 year of therapy (T2), using a standardized protocol in natural head position (NHP). Measurements were performed digitally using Dolphin Imaging software. The study assessed angular parameters such as the submental-facial angle, cervicomental angle, lip-jaw-throat angle, and Sm-E plane angle from photographs, as well as linear measurements from cephalometric radiographs, including throat length, jaw tip contour, soft tissue pogonion thickness, soft tissue menton thickness, and lower lip-pogonion distance.
Sample size was determined via power analysis, which indicated that 15 patients per group were sufficient to detect clinically meaningful differences. To ensure measurement reliability, cephalometric analyses were repeated, and intra-observer reliability was confirmed with an intraclass correlation coefficient (ICC) of 0.924.
Statistical analyses were conducted using R software. Paired t-tests were employed for within-group comparisons, while independent t-tests and ANOVA with Tukey's post hoc tests were used for intergroup comparisons. Mixed-effects models and chi-square tests were utilized where appropriate. A significance level of p < 0.05 was adopted for all analyses.
This study was designed to contribute to the understanding of how Twin Block functional appliance therapy influences the morphology of the mandibular and cervical soft tissues, using both photographic and radiographic assessments in a growing patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Class II Division I malocclusion caused by mandibular retrognathia | Experimental | Device: Twin block applianceClass II Division I patients treated with the Twin Block appliance |
| Class II Division II malocclusion caused by mandibular retrognathia | Experimental | Device: Twin block applianceClass II Division II patients treated with the Twin Block appliance |
| Skeletal Class I patients | Experimental | Other: Fixed orthodontic treatmentClass I patients who received fixed treatment |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- having Class II malocclusion caused by mandibular retrognathia (ANB > 4°, SNB<78°),
- exhibiting horizontal and/or normal growth pattern (SN-GoGn=32 ±6),
- having profile photographs and cephalometric radiographs taken in the NHP (using the self-balance method one of the dynamic approaches for determining NHP)15,
- not requiring rapid maxillary expansion,
- not having increased initial lower incisor inclination on lateral cephalometric radiographs,
Key exclusion criteria (3 listed)
- previous orthodontic treatment,
- presence of craniofacial anomalies involving the jaw and/or teeth,
- severe facial asymmetry
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 |
|---|---|---|
| Twin block applianceAn appliance that facilitates forward positioning of the mandible and soft tissues | Device | Class II Division I malocclusion caused by mandibular retrognathia, Class II Division II malocclusion caused by mandibular retrognathia |
| Fixed orthodontic treatmentPatients undergoing orthodontic treatment with fixed appliances | Other | Skeletal Class I patients |
Primary outcome
Patients treated with the Twin Block appliance
Time frame: 12 month
The changes in certain angular (degrees) and linear (millimeters) measurements may be considered favorable for the mandibular soft tissues.
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 18 Apr 2025.
- Results publication: PubMed 19064675Malkoc S, Demir A, Uysal T, Canbuldu N. Angular photogrammetric analysis of the soft tissue facial profile of Turkish adults. Eur J Orthod. 2009 Apr;31(2):174-9. doi: 10.1093/ejo/cjn082. Epub 2008 Dec 8.
- Individual participant dataSharing planned: No
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Comparative Evaluation of Functional and Aesthetic Outcomes of Box and Mini-Wing Genioplasty Techniques
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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.
Seda Sağoğlu principal investigator
Konya Necmettin Erbaka University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twin block appliance and Fixed orthodontic treatment in people with Mandibular Retrognathism, run by Konya Necmettin Erbakan Üniversitesi 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 7 inclusion and 3 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 18 Apr 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 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?
Patients treated with the Twin Block appliance (time frame: 12 month). 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 NCT06935032, 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 18 Apr 2025.