Class III MalocclusionCACIIIEANCT06763900

Corticotomy-Assisted Class III Elastic Applications

A study testing Skeletal anchorage and intermaxillary elastic assisted maxillary protraction in people with Class III Malocclusion, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This prospective randomized clinical study aimed to evaluate the effectiveness of corticotomy-assisted maxillary protraction with three different miniplate and intermaxillary elastic applications after corticotomy in patients with skeletal Class III malocclusion. Read more about this study

Who is it for?: Ages 13 to 15 years
Conditions the study is for: Class III Malocclusion
What is being tested?: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 14 Mar 2022to 6 May 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 13 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Skeletal Class III malocclusion
ANB angle between 0 and -4°
normal or horizontal growth pattern
anterior crossbite or edge-to-edge incisor relationship
permanent dentition

Who cannot join

requirement for maxillary expansion
pseudo-Class III malocclusion
inadequate oral hygiene
missing tooth in the upper dentition

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Erciyes University Faculty of Dentistry, Department of Orthodontics
Kayseri, Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of Corticotomy-Assisted Different Miniplate and Intermaxillary Elastic Applications After Growth Spurt in Individuals with Skeletal Class III Malocclusion

Read the detailed description

In acrylic splint group (AS) and palatal miniscrew group (MS), an acrylic splint containing hooks in the upper molar region was prepared and cemented. In the MS group, two miniscrews were used in the palatal region for additional anchorage. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery.

Conditions: Class III Malocclusion
Being tested: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction
Keywords: Class III Malocclusion, Miniplates, Corticotomy, Skeletal Anchorage, Class III Elastics
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.

Skeletal anchorage and intermaxillary elastic assisted maxillary protractionDevice
maxillary protraction with corticotomy-assisted different miniplate and intermaxillary elastic applications after growth spurt in patients with skeletal Class III malocclusion

Study groups in NCT06763900
Study group	Role	What they receive
Miniplate Group (MP)	Experimental	An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region. Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1). Receives: Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction
Acrylic Splint Group (AS)	Experimental	An acrylic splint containing hooks in the upper molar region was prepared and cemented to the upper dentition. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1). Receives: Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction
Palatal Miniscrew Supported Acrylic Splint Group (MS)	Experimental	An acrylic splint containing hooks in the upper molar region was prepared and cemented to the upper dentition. Two miniscrews were used in the palatal region for additional anchorage. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1). Receives: Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

What is being measured

The primary outcome is the main question the study is designed to answer.

Maxillomandibular sagittal changes
Investigation of Angular changes in SNA (°), SNB (°), ANB (°) measurements. Investigation of Distance changes in Wits (mm), A-Na Perp (mm), Co-A (mm), A-VRL (mm), and B-VRL (mm) measurements.
Measured: Through study completion, an avarage of 6 months
Vertical changes
Investigation of Angular changes in Y-axis angle (°), SN-GoGN (°), SN-PP (°), Jarabak ratio measurements.
Investigation of Distance changes in A-HRL (mm) measurement.
Measured: Through study completion, an avarage of 6 months
Dentoalveolar changes
Investigation of Angular changes in U1-SN (°), U1-PP (°), IMPA (°) measurements.
Investigation of Distance changes in Overjet (mm), Overbite (mm), U1-VRL (mm), and U6-VRL (mm) measurements.
Measured: Through study completion, an avarage of 6 months
Soft tissue changes
Investigation of Angular changes in soft tissue convexity (°), NA-Pog (°) measurements.
Investigation of Distance changes in VRL-prn (mm), VRL-Is (mm), VRL-li (mm), VRL-pog (mm), and ANS-Me (mm) measurements.
Measured: Through study completion, an avarage of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 20226 May 2023

First posted8 Jan 2025
Study start14 Mar 2022
Primary completion29 Mar 2023
Study completion6 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)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
Model description: Twenty patients aged between 13-15 years were randomly divided into three groups. In acrylic splint group (AS) and palatal miniscrew group (MS), an acrylic splint containing hooks in the upper molar region was prepared and cemented. In the MS group, two miniscrews were used in the palatal region for additional anchorage. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06763900
Sponsor's protocol ID: TDH-2022-11536
Acronym: CACIIIEA
Status last verified: Jun 2023
First submitted: 7 Jun 2023
Last updated: 8 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

De Clerck HJ, Cornelis MA, Cevidanes LH, Heymann GC, Tulloch CJ. Orthopedic traction of the maxilla with miniplates: a new perspective for treatment of midface deficiency. J Oral Maxillofac Surg. 2009 Oct;67(10):2123-9. doi: 10.1016/j.joms.2009.03.007. No abstract available.
PubMed 19761906
Yilmaz HN, Garip H, Satilmis T, Kucukkeles N. Corticotomy-assisted maxillary protraction with skeletal anchorage and Class III elastics. Angle Orthod. 2015 Jan;85(1):48-57. doi: 10.2319/121513-921.1.
PubMed 24913740
Willmann JH, Nienkemper M, Tarraf NE, Wilmes B, Drescher D. Early Class III treatment with Hybrid-Hyrax - Facemask in comparison to Hybrid-Hyrax-Mentoplate - skeletal and dental outcomes. Prog Orthod. 2018 Oct 22;19(1):42. doi: 10.1186/s40510-018-0239-8.
PubMed 30345472
Kircelli BH, Pektas ZO. Midfacial protraction with skeletally anchored face mask therapy: a novel approach and preliminary results. Am J Orthod Dentofacial Orthop. 2008 Mar;133(3):440-9. doi: 10.1016/j.ajodo.2007.06.011.
PubMed 18331946
Sar C, Sahinoglu Z, Ozcirpici AA, Uckan S. Dentofacial effects of skeletal anchored treatment modalities for the correction of maxillary retrognathia. Am J Orthod Dentofacial Orthop. 2014 Jan;145(1):41-54. doi: 10.1016/j.ajodo.2013.09.009.
PubMed 24373654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Not yet recruiting
3D Printed Occlusal Splints for Intraoperative Use
Malocclusion, Angle Class I, Malocclusion, Angle Class II
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion

All Class III Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Effectiveness of Corticotomy-Assisted Different Miniplate and Intermaxillary Elastic Applications After Growth Spurt in Individuals with Skeletal Class III Malocclusion
ClinicalTrials.gov ID: NCT06763900
Acronym / sponsor ID: CACIIIEA / TDH-2022-11536
Conditions: Class III Malocclusion
Keywords: Class III Malocclusion, Miniplates, Corticotomy, Skeletal Anchorage, Class III Elastics
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: TC Erciyes UniversityUniversity, hospital or other
Study start: 14 Mar 2022 (actual)
Primary completion: 29 Mar 2023 (actual)
Study completion: 6 May 2023 (actual)
First posted: 8 Jan 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Twenty patients aged between 13-15 years were randomly divided into three groups. In acrylic splint group (AS) and palatal miniscrew group (MS), an acrylic splint containing hooks in the upper molar region was prepared and cemented. In the MS group, two miniscrews were used in the palatal region for additional anchorage. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).

Arm	Type	Receives
Miniplate Group (MP)	Experimental	Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protractionAn incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region. Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).
Acrylic Splint Group (AS)	Experimental	Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protractionAn acrylic splint containing hooks in the upper molar region was prepared and cemented to the upper dentition. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).
Palatal Miniscrew Supported Acrylic Splint Group (MS)	Experimental	Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protractionAn acrylic splint containing hooks in the upper molar region was prepared and cemented to the upper dentition. Two miniscrews were used in the palatal region for additional anchorage. An incomplete Le Fort 1 osteotomy was performed in all patients to free the maxilla. Miniplates were placed vertically between the mandibular canine and first premolar in all groups, and horizontally under the osteotomy line in the maxillary molar region in miniplate group (MP). Class III elastics were applied 5 days after the surgery. Treatment was continued until a positive overjet was achieved. Cephalometric radiographs were taken at the beginning of treatment (T0) and at the end of the protraction period (T1).

Who may qualify

Ages: 13 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Skeletal Class III malocclusion
ANB angle between 0 and -4°
normal or horizontal growth pattern
anterior crossbite or edge-to-edge incisor relationship
permanent dentition

Key exclusion criteria (4 listed)

requirement for maxillary expansion
pseudo-Class III malocclusion
inadequate oral hygiene
missing tooth in the upper dentition

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
Skeletal anchorage and intermaxillary elastic assisted maxillary protractionmaxillary protraction with corticotomy-assisted different miniplate and intermaxillary elastic applications after growth spurt in patients with skeletal Class III malocclusion	Device	Acrylic Splint Group (AS), Miniplate Group (MP), Palatal Miniscrew Supported Acrylic Splint Group (MS)

Primary outcome

Maxillomandibular sagittal changes
Time frame: Through study completion, an avarage of 6 months
Investigation of Angular changes in SNA (°), SNB (°), ANB (°) measurements. Investigation of Distance changes in Wits (mm), A-Na Perp (mm), Co-A (mm), A-VRL (mm), and B-VRL (mm) measurements.
Vertical changes
Time frame: Through study completion, an avarage of 6 months
Investigation of Angular changes in Y-axis angle (°), SN-GoGN (°), SN-PP (°), Jarabak ratio measurements. Investigation of Distance changes in A-HRL (mm) measurement.
Dentoalveolar changes
Time frame: Through study completion, an avarage of 6 months
Investigation of Angular changes in U1-SN (°), U1-PP (°), IMPA (°) measurements. Investigation of Distance changes in Overjet (mm), Overbite (mm), U1-VRL (mm), and U6-VRL (mm) measurements.
Soft tissue changes
Time frame: Through study completion, an avarage of 6 months
Investigation of Angular changes in soft tissue convexity (°), NA-Pog (°) measurements. Investigation of Distance changes in VRL-prn (mm), VRL-Is (mm), VRL-li (mm), VRL-pog (mm), and ANS-Me (mm) measurements.

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 8 Jan 2025.
Background: PubMed 19761906De Clerck HJ, Cornelis MA, Cevidanes LH, Heymann GC, Tulloch CJ. Orthopedic traction of the maxilla with miniplates: a new perspective for treatment of midface deficiency. J Oral Maxillofac Surg. 2009 Oct;67(10):2123-9. doi: 10.1016/j.joms.2009.03.007. No abstract available.
Background: PubMed 24913740Yilmaz HN, Garip H, Satilmis T, Kucukkeles N. Corticotomy-assisted maxillary protraction with skeletal anchorage and Class III elastics. Angle Orthod. 2015 Jan;85(1):48-57. doi: 10.2319/121513-921.1.
Background: PubMed 30345472Willmann JH, Nienkemper M, Tarraf NE, Wilmes B, Drescher D. Early Class III treatment with Hybrid-Hyrax - Facemask in comparison to Hybrid-Hyrax-Mentoplate - skeletal and dental outcomes. Prog Orthod. 2018 Oct 22;19(1):42. doi: 10.1186/s40510-018-0239-8.
Background: PubMed 18331946Kircelli BH, Pektas ZO. Midfacial protraction with skeletally anchored face mask therapy: a novel approach and preliminary results. Am J Orthod Dentofacial Orthop. 2008 Mar;133(3):440-9. doi: 10.1016/j.ajodo.2007.06.011.
Background: PubMed 24373654Sar C, Sahinoglu Z, Ozcirpici AA, Uckan S. Dentofacial effects of skeletal anchored treatment modalities for the correction of maxillary retrognathia. Am J Orthod Dentofacial Orthop. 2014 Jan;145(1):41-54. doi: 10.1016/j.ajodo.2013.09.009.
Individual participant dataSharing planned: No

Related trials for Class III Malocclusion

Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Not yet recruiting
3D Printed Occlusal Splints for Intraoperative Use
Malocclusion, Angle Class I, Malocclusion, Angle Class II
Not yet recruiting
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
Skeletal Class II Malocclusion, Skeletal Class III Malocclusion

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.

Ahmet YAĞCI, Professor study director

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Skeletal anchorage and intermaxillary elastic assisted maxillary protraction in people with Class III Malocclusion, run by TC Erciyes 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 4 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 8 Jan 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?

Maxillomandibular sagittal changes (time frame: Through study completion, an avarage of 6 months). The study lists 4 primary outcomes in all. 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 NCT06763900, which also lists 5 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 8 Jan 2025.