Class III MalocclusionNCT06859606
Mandibular Sequential Distalization Versus Class III Elastics With Clear Aligners in Class III Patients
A study testing Lower molar distalization and Class III elastics in people with Class III Malocclusion, run by Saint Camillus International University of Health Sciences at 1 site in Italy.
Trial summary
Distalizing mandibular molars may be indicated for patients with minor skeletal Class III discrepancies or in Class III subjects with mild crowding. Traditionally, mandibular molar distalization was accomplished using elastics, open coils, and the multiloop edgewise archwire technique. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- Lower molar distalization and Class III elastics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 10 Jan 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult age (≥19 years)
- permanent dentition including second permanent molars
- skeletal Class I or slight Class III (-2° < ANB < +2°)
- normal skeletal divergency pattern (SN^GoGn, 27°-37°)
- Class III canine and molar relationship at baseline (T0), moderate lower arch crowding (≤ +4 mm)
- good compliance with aligners and elastics (≥ 20 hours/day)
Who cannot join
- severe skeletal Class III malocclusion (ANB < -2°)
- transversal maxillary deficiency
- use of Temporary Anchorage Devices (TADs)
- extraction treatments other than third molars
- periodontal disease or temporomandibular disorders (TMDs).
Trial locations and contacts
1 site in 1 country.
Italy1 site
Saint Camillus International University of Health Sciences
Rome, 00131
About this study
Official title: Mandibular Sequential Distalization Versus Class III Elastics With Clear Aligners in Class III Patients: a Randomized Controlled Trial
Distalizing mandibular molars may be indicated for patients with minor skeletal Class III discrepancies or in Class III subjects with mild crowding. Traditionally, mandibular molar distalization was accomplished using elastics, open coils, and the multiloop edgewise archwire technique. In recent years, several techniques have been developed to reduce the dependence on patient compliance, such as skeletal anchorage. Recently, several reports have been published on mandibular distal movement using miniscrews and some case reports have shown the possibility of obtaining Class III correction with sequential mandibular distalization in non-growing subjects by means of clear aligners. However, a sound clinical judgment should always be made on the basis of a higher level of evidence. Therefore, the purpose of the present prospective study is to provide a detailed analysis of the underlying skeletal and dental changes determined by mandibular distalization therapy with the sequential Invisalign protocol in permanent dentition. This will be accomplished by testing the following null hypothesis: mandibular molar distalization is not achievable with aligners without the application of TADs.
Read the detailed description
Class III malocclusion is considered one of the most challenging maxillofacial disorders in clinical practice characterized by an antero-posterior discrepancy with mandibular protrusion, maxillary retrusion, or a combination of both. In adult patients, managing this condition is further complicated by the absence of residual skeletal growth, limiting therapeutic options to orthodontic interventions and, in some cases, surgical procedures. Diagnosis in Class III adult patients requires distinguishing between skeletal malocclusion and dento-alveolar discrepancy. The combination of orthognathic surgery and orthodontic therapy represents the gold standard for more severe skeletal Class III disharmonies, leading to an improvement of both function and aesthetics. On the other hand, in Class III cases characterized by a prevalent dental component or mild skeletal discrepancy, the malocclusion can be addressed with a dento-alveolar compensation. In these cases, the clinical objectives are to achieve a correct sagittal, canine and molar Class I relationship, as well as ideal values of overjet and overbite. The non-surgical orthopedic approach involves the application of Class III elastics or the distalization of the lower molars, which can improve the sagittal occlusal relationship. As a matter of fact, mandibular distalization allows the increase of lower arch length along with the achievement of the necessary space to correct a Class III relationship. However, bone density and root anatomy make lower molar distalization difficult to achieve. In addition, one of the most frequent adverse effects is represented by the anterior anchorage loss with a worsening of lower incisor proclination and overjet values. Traditional appliances feature the use of open coil springs, inter arch elastics, and lip bumper device combined with fixed appliances. Nowadays, the development of clear aligner technology provides new opportunities even in the management of complex malocclusion cases, including Class III discrepancies. In particular, molar distalization movements and intermaxillary elastics have been proposed as a valid clinical strategy to improve the occlusal relationship without requiring skeletal anchorage devices. During the sagittal mechanics, over-corrected movements should be planned in order to obtain more bodily movements of the lower molars. Moreover, the best accuracy and predictability of distalization movements are supported by the sequential staging and the presence of attachments on the tooth surfaces. Nowadays, scientific evidence on this topic is limited and it is influenced by restrictions in terms of sample size, retrospective design, and lack of long-term observation. Hence, the aim of the present study was to evaluate the efficacy and efficiency of intermaxillary elastics combined with lower molar distalization by means of clear aligners in the treatment of Class III malocclusion in adult patients. More specifically, a randomized controlled trial (RCT) was conducted to evaluate the antero-posterior correction induced by Class III elastics combined with lower distalization movements and the application of Class III elastics alone. The possibility of achieving satisfying clinical outcomes without the use of skeletal anchorage was considered to avoid an invasive orthodontic approach
- Conditions
- Class III Malocclusion
- Being tested
- Lower molar distalization, Class III elastics
- Keywords
- class III malocclusion, lower molar distalization, class III elastics, clear aligner treatment
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower molar distalizationOther
Lower Distalization Protocol included extraction of the lower third molars before starting treatment and a 50% sequential lower distalization with two teeth being distalized at a time. The distalization started with the movement of lower second molars, followed by the first molars halfway through the process, and so on. Once the canine reached the right position, the "en masse" retraction of the four incisors completed the treatment plan. The protocol comprised the use of Class III intermaxillary elastics to support the distalization movement and to control the proclination of lower incisors
Class III elasticsOther
Non-Distalization Protocol featured extraction of the lower third molars before starting treatment, transversal dento-alveolar coordination, strategic interproximal reduction (IPR) in the anterior segment of the lower arch, and the addition of Class III elastics
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Lower Distalization Protocol | Experimental | In Group 1 (Lower Distalization Protocol), all subjects underwent lower molar distalization combined with Class III elastics. Receives: Other: Lower molar distalization |
| Group 2, Non-Distalization Protocol | Experimental | In Group 2 (Non-Distalization Protocol) all subjects were treated with dento-alveolar expansion and Class III elastics Receives: Other: Class III elastics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower molar positional changes expressed by means of linear and angular measurements (L6-MP mm; L6-MP angle; L6 - CoGo mm; L6 apex - CoGo mm)
L6-MP mm: linear distance between the mesial cusp of lower first molar and Mandibular plane L6-MP angle: angle between long axis of lower first molar and Mandibular plane L6 - CoGo mm: linear distance between the mesial cusp of lower first molar and CoGo line L6 apex - CoGo mm: linear distance between the apex of lower first molar and CoGo line
Measured: from the start of treatment to the end at 24 months
Secondary outcomes (7)
Changes in inclination of the lower incisors (IMPA angle)
IMPA angle: angle between long axis of the lower incisor and mandibular plane
Measured: from the start of treatment to the and at 24 months
Changes in position of the lower incisors (L1-CoGo mm; L1apex - CoGo)
L1-CoGo mm: linear distance between the tip crown of the lower incisor L1apex - CoGo mm: linear distance between the apex of the lower incisor and CoGo line
Measured: from the start of treatment to the and at 24 months
Sagittal skeletal changes (SNA angle, SNB angle, ANB angle)
SNA angle: maxillary sagittal position SNB angle: mandibular sagittal position ANB angle: maxillomandibular sagittal discrepancy
Measured: from start of treatment to to the end at 24 months
Sagittal skeletal changes (Wits appraisal)
Wits appraisal: maxillomandibular sagittal discrepancy
Measured: from start of treatment to to the end at 24 months
Vertical skeletal changes (SN^MP angle, Gonial Angle)
SN-MP angle between Sella/Nasion plane and Mandibular plane Gonial angle, angle between Ar-Go plane and Go-Me plane
Measured: from the start of treatment to the end at 24 months
Changes of upper incisors inclination
Incisor inclintion: angle between long axis of upper incisor and Sella Nasion
Measured: from the start of treatment to the and at 24 months
Overbite and Overjet values
Overbite mm: horizontal distance between the upper and lower incisors on the occlusal plane Overjet mm: vertical distance between the upper and lower incisors on the occlusal plane
Measured: from the start of treatment to the and at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Dec 2022
- Primary completion1 Dec 2024
- Study completion10 Jan 2025
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 Class III MalocclusionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Camillus International University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Gazzani, Saint Camillus International University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859606
- Sponsor's protocol ID
- 75.23
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martina H, Stefano Adriana A, Ernesto B, Alessandra I, Roberto AV, Gabriella G. Lower molar distalization using clear aligners: Is it effective? A systematic review. J Orthod Sci. 2024 Feb 16;13:11. doi: 10.4103/jos.jos_174_23. eCollection 2024.
PubMed 38516119Rota E, Parrini S, Malekian K, Cugliari G, Mampieri G, Deregibus A, Castroflorio T. Lower molar distalization using clear aligners: bodily movement or uprighting? A preliminary study. Appl. Sci. 2022, 12(14), 7123.
Han J, Ning N, Du H, Zhou M, Cai C, Hong Y, et al. Efficacy of clear aligners on mandibular molar distalization: A retrospective study. Digit Med 2021; 7:1.
Padmanabhan A, Khan Y, Lambate V, K U, Naveed N, Singh M, Nagi PK. Efficacy of Clear Aligners in Treating Class III Malocclusion With Mandibular Molar Distalization: A Systematic Review. Cureus. 2023 Nov 1;15(11):e48134. doi: 10.7759/cureus.48134. eCollection 2023 Nov.
PubMed 38046776Pavoni C, Gazzani F, Franchi L, Loberto S, Lione R, Cozza P. Soft tissue facial profile in Class III malocclusion: long-term post-pubertal effects produced by the Face Mask Protocol. Eur J Orthod. 2019 Sep 21;41(5):531-536. doi: 10.1093/ejo/cjz003.
PubMed 30865768Gazzani F, Pavoni C, De Razza FC, Lugli L, Cozza P, Lione R. Clear aligner treatment in adult patients with class III malocclusion: lower distalization and class III elastics vs class III elastics alone - a RCT. Eur J Orthod. 2025 Jun 12;47(4):cjaf052. doi: 10.1093/ejo/cjaf052.
PubMed 40600239
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Sequential Distalization Versus Class III Elastics With Clear Aligners in Class III Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06859606
- Acronym / sponsor ID
- 75.23
- Conditions
- Class III Malocclusion
- Keywords
- class III malocclusion, lower molar distalization, class III elastics, clear aligner treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Saint Camillus International University of Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 5 Mar 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.
Distalizing mandibular molars may be indicated for patients with minor skeletal Class III discrepancies or in Class III subjects with mild crowding. Traditionally, mandibular molar distalization was accomplished using elastics, open coils, and the multiloop edgewise archwire technique. In recent years, several techniques have been developed to reduce the dependence on patient compliance, such as skeletal anchorage. Recently, several reports have been published on mandibular distal movement using miniscrews and some case reports have shown the possibility of obtaining Class III correction with sequential mandibular distalization in non-growing subjects by means of clear aligners. However, a sound clinical judgment should always be made on the basis of a higher level of evidence. Therefore, the purpose of the present prospective study is to provide a detailed analysis of the underlying skeletal and dental changes determined by mandibular distalization therapy with the sequential Invisalign protocol in permanent dentition. This will be accomplished by testing the following null hypothesis: mandibular molar distalization is not achievable with aligners without the application of TADs.
Detailed description
Class III malocclusion is considered one of the most challenging maxillofacial disorders in clinical practice characterized by an antero-posterior discrepancy with mandibular protrusion, maxillary retrusion, or a combination of both. In adult patients, managing this condition is further complicated by the absence of residual skeletal growth, limiting therapeutic options to orthodontic interventions and, in some cases, surgical procedures. Diagnosis in Class III adult patients requires distinguishing between skeletal malocclusion and dento-alveolar discrepancy. The combination of orthognathic surgery and orthodontic therapy represents the gold standard for more severe skeletal Class III disharmonies, leading to an improvement of both function and aesthetics. On the other hand, in Class III cases characterized by a prevalent dental component or mild skeletal discrepancy, the malocclusion can be addressed with a dento-alveolar compensation. In these cases, the clinical objectives are to achieve a correct sagittal, canine and molar Class I relationship, as well as ideal values of overjet and overbite. The non-surgical orthopedic approach involves the application of Class III elastics or the distalization of the lower molars, which can improve the sagittal occlusal relationship. As a matter of fact, mandibular distalization allows the increase of lower arch length along with the achievement of the necessary space to correct a Class III relationship. However, bone density and root anatomy make lower molar distalization difficult to achieve. In addition, one of the most frequent adverse effects is represented by the anterior anchorage loss with a worsening of lower incisor proclination and overjet values. Traditional appliances feature the use of open coil springs, inter arch elastics, and lip bumper device combined with fixed appliances. Nowadays, the development of clear aligner technology provides new opportunities even in the management of complex malocclusion cases, including Class III discrepancies. In particular, molar distalization movements and intermaxillary elastics have been proposed as a valid clinical strategy to improve the occlusal relationship without requiring skeletal anchorage devices. During the sagittal mechanics, over-corrected movements should be planned in order to obtain more bodily movements of the lower molars. Moreover, the best accuracy and predictability of distalization movements are supported by the sequential staging and the presence of attachments on the tooth surfaces. Nowadays, scientific evidence on this topic is limited and it is influenced by restrictions in terms of sample size, retrospective design, and lack of long-term observation. Hence, the aim of the present study was to evaluate the efficacy and efficiency of intermaxillary elastics combined with lower molar distalization by means of clear aligners in the treatment of Class III malocclusion in adult patients. More specifically, a randomized controlled trial (RCT) was conducted to evaluate the antero-posterior correction induced by Class III elastics combined with lower distalization movements and the application of Class III elastics alone. The possibility of achieving satisfying clinical outcomes without the use of skeletal anchorage was considered to avoid an invasive orthodontic approach
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Lower Distalization Protocol | Experimental | Other: Lower molar distalizationIn Group 1 (Lower Distalization Protocol), all subjects underwent lower molar distalization combined with Class III elastics. |
| Group 2, Non-Distalization Protocol | Experimental | Other: Class III elasticsIn Group 2 (Non-Distalization Protocol) all subjects were treated with dento-alveolar expansion and Class III elastics |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adult age (≥19 years)
- permanent dentition including second permanent molars
- skeletal Class I or slight Class III (-2° < ANB < +2°)
- normal skeletal divergency pattern (SN^GoGn, 27°-37°)
- Class III canine and molar relationship at baseline (T0), moderate lower arch crowding (≤ +4 mm)
Key exclusion criteria (5 listed)
- severe skeletal Class III malocclusion (ANB < -2°)
- transversal maxillary deficiency
- use of Temporary Anchorage Devices (TADs)
- extraction treatments other than third molars
- periodontal disease or temporomandibular disorders (TMDs).
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 |
|---|---|---|
| Lower molar distalizationLower Distalization Protocol included extraction of the lower third molars before starting treatment and a 50% sequential lower distalization with two teeth being distalized at a time. The distalization started with the movement of lower second molars, followed by the first molars halfway through the process, and so on. Once the canine reached the right position, the "en masse" retraction of the four incisors completed the treatment plan. The protocol comprised the use of Class III intermaxillary elastics to support the distalization movement and to control the proclination of lower incisors | Other | Group 1 - Lower Distalization Protocol |
| Class III elasticsNon-Distalization Protocol featured extraction of the lower third molars before starting treatment, transversal dento-alveolar coordination, strategic interproximal reduction (IPR) in the anterior segment of the lower arch, and the addition of Class III elastics | Other | Group 2, Non-Distalization Protocol |
Primary outcome
Lower molar positional changes expressed by means of linear and angular measurements (L6-MP mm; L6-MP angle; L6 - CoGo mm; L6 apex - CoGo mm)
Time frame: from the start of treatment to the end at 24 months
L6-MP mm: linear distance between the mesial cusp of lower first molar and Mandibular plane L6-MP angle: angle between long axis of lower first molar and Mandibular plane L6 - CoGo mm: linear distance between the mesial cusp of lower first molar and CoGo line L6 apex - CoGo mm: linear distance between the apex of lower first molar and CoGo line
7 secondary outcomes
Changes in inclination of the lower incisors (IMPA angle)
Time frame: from the start of treatment to the and at 24 months
Changes in position of the lower incisors (L1-CoGo mm; L1apex - CoGo)
Time frame: from the start of treatment to the and at 24 months
Sagittal skeletal changes (SNA angle, SNB angle, ANB angle)
Time frame: from start of treatment to to the end at 24 months
Sagittal skeletal changes (Wits appraisal)
Time frame: from start of treatment to to the end at 24 months
Vertical skeletal changes (SN^MP angle, Gonial Angle)
Time frame: from the start of treatment to the end at 24 months
Changes of upper incisors inclination
Time frame: from the start of treatment to the and at 24 months
Overbite and Overjet values
Time frame: from the start of treatment to the and at 24 months
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 5 Mar 2025.
- Background: PubMed 38516119Martina H, Stefano Adriana A, Ernesto B, Alessandra I, Roberto AV, Gabriella G. Lower molar distalization using clear aligners: Is it effective? A systematic review. J Orthod Sci. 2024 Feb 16;13:11. doi: 10.4103/jos.jos_174_23. eCollection 2024.
- BackgroundRota E, Parrini S, Malekian K, Cugliari G, Mampieri G, Deregibus A, Castroflorio T. Lower molar distalization using clear aligners: bodily movement or uprighting? A preliminary study. Appl. Sci. 2022, 12(14), 7123.
- BackgroundHan J, Ning N, Du H, Zhou M, Cai C, Hong Y, et al. Efficacy of clear aligners on mandibular molar distalization: A retrospective study. Digit Med 2021; 7:1.
- Background: PubMed 38046776Padmanabhan A, Khan Y, Lambate V, K U, Naveed N, Singh M, Nagi PK. Efficacy of Clear Aligners in Treating Class III Malocclusion With Mandibular Molar Distalization: A Systematic Review. Cureus. 2023 Nov 1;15(11):e48134. doi: 10.7759/cureus.48134. eCollection 2023 Nov.
- Background: PubMed 30865768Pavoni C, Gazzani F, Franchi L, Loberto S, Lione R, Cozza P. Soft tissue facial profile in Class III malocclusion: long-term post-pubertal effects produced by the Face Mask Protocol. Eur J Orthod. 2019 Sep 21;41(5):531-536. doi: 10.1093/ejo/cjz003.
- Derived from this study: PubMed 40600239Gazzani F, Pavoni C, De Razza FC, Lugli L, Cozza P, Lione R. Clear aligner treatment in adult patients with class III malocclusion: lower distalization and class III elastics vs class III elastics alone - a RCT. Eur J Orthod. 2025 Jun 12;47(4):cjaf052. doi: 10.1093/ejo/cjaf052.
- Individual participant dataSharing planned: Undecided
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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 Lower molar distalization and Class III elastics in people with Class III Malocclusion, run by Saint Camillus International University of Health Sciences 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 6 inclusion and 5 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 5 Mar 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 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?
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?
Lower molar positional changes expressed by means of linear and angular measurements (L6-MP mm; L6-MP angle; L6 - CoGo mm; L6 apex - CoGo mm) (time frame: from the start of treatment to the end at 24 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 NCT06859606, 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 5 Mar 2025.