Mandibular RetrognathiaNCT07056829
The Effect of Mandibular Advancement With Clear Aligners on Maxillary and Mandibular Volumes
A study testing Mandibular Advancement Appliance (Invisalign MA) and Activator Appliance in people with Mandibular Retrognathia, run by Batman University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effectiveness of two different orthodontic treatment methods used in patients with skeletal Class II malocclusion, a condition in which the lower jaw is positioned backward. Approximately 80% of Class II malocclusions are due to mandibular retrusion. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mandibular Retrognathia
- What is being tested?
- Mandibular Advancement Appliance (Invisalign MA) and Activator Appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cervical vertebral maturation (CVM) stage 2 or 3
- Bilateral full or half cusp Class II molar relationship
- Skeletal Class II relationship associated with mandibular retrognathia (ANB angle > 4° and SNB angle < 78°)
- Horizontal or average growth pattern (SN-GoGn ≤ 38°)
- Overjet distance between +4 mm and +8 mm; (6) Good patient compliance throughout the treatment.
Who cannot join
- CVM stage 5 or 6;(2) Previous orthodontic treatment;
- Presence of maxillary prognathism
- High-angle growth pattern (SN-GoGn > 38°)
- Transverse orthodontic anomalies or facial asymmetry
- Palpation-induced tenderness or pain in the masticatory muscles
- Presence of clicking, crepitus, pain, or tenderness in the temporomandibular joint (TMJ)
Show all 9Show fewer
- Congenital or acquired craniofacial deformities
- Poor patient compliance or oral hygiene
- Any condition that could interfere with CBCT imaging.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandibular Advancement With Clear Aligners on Maxillary and Mandibular Volumes: A Randomized Controlled Trial Using CBCT
The aim of this study is to compare the effectiveness of two different orthodontic treatment methods used in patients with skeletal Class II malocclusion, a condition in which the lower jaw is positioned backward. Approximately 80% of Class II malocclusions are due to mandibular retrusion. Therefore, functional appliances that stimulate mandibular growth in growing individuals have been widely used in orthodontics for many years.
In recent years, clear aligner systems have become increasingly popular in orthodontic practice. A mandibular advancement feature was recently integrated into these aligners, allowing for simultaneous tooth alignment and forward positioning of the lower jaw. In this study, the newly developed Mandibular Advancement Appliance (MAA), based on clear aligners, will be compared to the traditional functional appliance known as the Activator.
Read more
Who Can Participate in the Study? Children with retrusive lower jaws who are in the growth and development period Individuals with no prior orthodontic treatment Patients with specific levels of dental protrusion (overjet) Those with good general health and no contraindications for CBCT imaging What Will the Treatment Process Involve?
Participants will be randomly assigned to one of three groups:
MAA group (clear aligners with mandibular advancement) Activator group (traditional removable appliance) Control group (no treatment, only observation) The active treatment period will last approximately 7-8 months, followed by a retention phase. All patients will be monitored regularly, and strict adherence to appliance use will be expected.
How Will the Outcomes Be Assessed? Before and after the treatment period, participants will undergo cone-beam computed tomography (CBCT) scans to obtain detailed three-dimensional images of the jaws. These images will be analyzed to evaluate volumetric changes. All measurements will be performed by a trained orthodontic specialist using dedicated software.
Potential Benefits for Participants:
Participants will receive close clinical monitoring throughout the study period. The use of advanced imaging technologies may support the development of more effective and individualized treatment plans.
Safety and Confidentiality:
This study has received ethical approval and will be conducted in accordance with relevant data protection and research ethics standards. All personal data will be kept confidential. Written informed consent will be obtained from all participants and/or their legal guardians.
- Conditions
- Mandibular Retrognathia
- Being tested
- Mandibular Advancement Appliance (Invisalign MA), Activator Appliance
- Keywords
- clear aligners, mandibular retrognathia, mandibular advancement
- Medical subject headings
- Micrognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement Appliance (Invisalign MA)Device
Clear aligner system with integrated buccal precision wings to posture the mandible forward.
Advancement protocol: 2 mm increments every 8 weeks. Total active treatment duration: ~8.15 months, followed by retention phase. Patients instructed to wear aligners ≥20 h/day, removing only for eating and oral hygiene.
Activator ApplianceDevice
Traditional removable functional appliance fabricated on a standardized bite registration.
Patients instructed to wear appliance 24 h/day except during meals and sports. Total active treatment duration: ~7.15 months, followed by retention phase.
| Study group | Role | What they receive |
|---|---|---|
| MAA Group | Experimental | Patients receive orthodontic treatment using clear aligners (Invisalign) with integrated mandibular advancement features (MAA). Advancement is performed in 2 mm increments every 8 weeks over ~8 months. Receives: Device: Mandibular Advancement Appliance (Invisalign MA) |
| Activator Group | Active comparator | Patients receive traditional removable functional appliance therapy (Activator) for ~7 months. Receives: Device: Activator Appliance |
| Control Group | No intervention | Patients receive no orthodontic treatment but are monitored for the same duration as the treatment groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mandibular volume (mm³)
Mandibular volume change will be measured using CBCT scans analyzed via Mimics software. The MAA and Activator groups will be compared to evaluate treatment effects.
Measured: Baseline and post-treatment (~8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 May 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 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 Mandibular RetrognathiaStudies 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
- This study follows a parallel assignment model. Participants are randomly assigned to one of three groups: the Mandibular Advancement Appliance (MAA) group, the Activator group, or the control group. Each group receives a different intervention or, in the case of the control group, no treatment, and all groups are observed over the same period without crossover between interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursezen Kavasoglu, Batman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056829
- Sponsor's protocol ID
- NK02
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kavasoglu N, Nai̇boglu E. The effect of mandibular advancement with clear aligners compared with activator therapy on maxillary and mandibular volumes: a randomized controlled trial using CBCT. BMC Oral Health. 2026 Feb 19;26(1):443. doi: 10.1186/s12903-026-07924-4.
PubMed 41709259
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandibular Advancement With Clear Aligners on Maxillary and Mandibular Volumes: A Randomized Controlled Trial Using CBCT
- ClinicalTrials.gov ID
- NCT07056829
- Acronym / sponsor ID
- NK02
- Conditions
- Mandibular Retrognathia
- Keywords
- clear aligners, mandibular retrognathia, mandibular advancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Batman UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 9 Jul 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.
The aim of this study is to compare the effectiveness of two different orthodontic treatment methods used in patients with skeletal Class II malocclusion, a condition in which the lower jaw is positioned backward. Approximately 80% of Class II malocclusions are due to mandibular retrusion. Therefore, functional appliances that stimulate mandibular growth in growing individuals have been widely used in orthodontics for many years.
In recent years, clear aligner systems have become increasingly popular in orthodontic practice. A mandibular advancement feature was recently integrated into these aligners, allowing for simultaneous tooth alignment and forward positioning of the lower jaw. In this study, the newly developed Mandibular Advancement Appliance (MAA), based on clear aligners, will be compared to the traditional functional appliance known as the Activator.
Who Can Participate in the Study? Children with retrusive lower jaws who are in the growth and development period Individuals with no prior orthodontic treatment Patients with specific levels of dental protrusion (overjet) Those with good general health and no contraindications for CBCT imaging What Will the Treatment Process Involve?
Participants will be randomly assigned to one of three groups:
MAA group (clear aligners with mandibular advancement) Activator group (traditional removable appliance) Control group (no treatment, only observation) The active treatment period will last approximately 7-8 months, followed by a retention phase. All patients will be monitored regularly, and strict adherence to appliance use will be expected.
How Will the Outcomes Be Assessed? Before and after the treatment period, participants will undergo cone-beam computed tomography (CBCT) scans to obtain detailed three-dimensional images of the jaws. These images will be analyzed to evaluate volumetric changes. All measurements will be performed by a trained orthodontic specialist using dedicated software.
Potential Benefits for Participants:
Participants will receive close clinical monitoring throughout the study period. The use of advanced imaging technologies may support the development of more effective and individualized treatment plans.
Safety and Confidentiality:
This study has received ethical approval and will be conducted in accordance with relevant data protection and research ethics standards. All personal data will be kept confidential. Written informed consent will be obtained from all participants and/or their legal guardians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study follows a parallel assignment model. Participants are randomly assigned to one of three groups: the Mandibular Advancement Appliance (MAA) group, the Activator group, or the control group. Each group receives a different intervention or, in the case of the control group, no treatment, and all groups are observed over the same period without crossover between interventions.
| Arm | Type | Receives |
|---|---|---|
| MAA Group | Experimental | Device: Mandibular Advancement Appliance (Invisalign MA)Patients receive orthodontic treatment using clear aligners (Invisalign) with integrated mandibular advancement features (MAA). Advancement is performed in 2 mm increments every 8 weeks over ~8 months. |
| Activator Group | Active comparator | Device: Activator AppliancePatients receive traditional removable functional appliance therapy (Activator) for ~7 months. |
| Control Group | No intervention | –Patients receive no orthodontic treatment but are monitored for the same duration as the treatment groups. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Cervical vertebral maturation (CVM) stage 2 or 3
- Bilateral full or half cusp Class II molar relationship
- Skeletal Class II relationship associated with mandibular retrognathia (ANB angle > 4° and SNB angle < 78°)
- Horizontal or average growth pattern (SN-GoGn ≤ 38°)
- Overjet distance between +4 mm and +8 mm; (6) Good patient compliance throughout the treatment.
Key exclusion criteria (9 listed)
- CVM stage 5 or 6;(2) Previous orthodontic treatment;
- Presence of maxillary prognathism
- High-angle growth pattern (SN-GoGn > 38°)
- Transverse orthodontic anomalies or facial asymmetry
- Palpation-induced tenderness or pain in the masticatory muscles
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 |
|---|---|---|
| Mandibular Advancement Appliance (Invisalign MA)Clear aligner system with integrated buccal precision wings to posture the mandible forward. Advancement protocol: 2 mm increments every 8 weeks. Total active treatment duration: ~8.15 months, followed by retention phase. Patients instructed to wear aligners ≥20 h/day, removing only for eating and oral hygiene. | Device | MAA Group |
| Activator ApplianceTraditional removable functional appliance fabricated on a standardized bite registration. Patients instructed to wear appliance 24 h/day except during meals and sports. Total active treatment duration: ~7.15 months, followed by retention phase. | Device | Activator Group |
Primary outcome
Change in mandibular volume (mm³)
Time frame: Baseline and post-treatment (~8 months)
Mandibular volume change will be measured using CBCT scans analyzed via Mimics software. The MAA and Activator groups will be compared to evaluate treatment effects.
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 9 Jul 2025.
- Derived from this study: PubMed 41709259Kavasoglu N, Nai̇boglu E. The effect of mandibular advancement with clear aligners compared with activator therapy on maxillary and mandibular volumes: a randomized controlled trial using CBCT. BMC Oral Health. 2026 Feb 19;26(1):443. doi: 10.1186/s12903-026-07924-4.
- 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?
A study testing Mandibular Advancement Appliance (Invisalign MA) and Activator Appliance in people with Mandibular Retrognathia, run by Batman 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 5 inclusion and 9 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 9 Jul 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?
Change in mandibular volume (mm³) (time frame: Baseline and post-treatment (~8 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 NCT07056829, 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 9 Jul 2025.