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CompletedNCT06763900CACIIIEAUpdated Jan 8, 2025

Corticotomy-Assisted Class III Elastic Applications

An interventional study of Skeletal anchorage and intermaxillary elastic assisted maxillary protraction in Class III Malocclusion, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to participants aged 13 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-01-08.

Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2022, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
13 Years to 15 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Class III Malocclusion

Keywords

  • Class III Malocclusion
  • Miniplates
  • Corticotomy
  • Skeletal Anchorage
  • Class III Elastics
03

In context

Malocclusion, Angle Class III

57 studies on the registry are indexed under Malocclusion, Angle Class III; 11 are open to participants now.

This study's enrollment of 20 is below the median of 32 across 53 interventional studies indexed under Malocclusion, Angle Class III.

Browse Malocclusion, Angle Class III studies →

Lead sponsor

TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • requirement for maxillary expansion
  • pseudo-Class III malocclusion
  • inadequate oral hygiene
  • missing tooth in the upper dentition
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Miniplate Group (MP)

    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).

    Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

  • Experimental
    Acrylic Splint Group (AS)

    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).

    Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

  • Experimental
    Palatal Miniscrew Supported Acrylic Splint Group (MS)

    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).

    Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

Interventions

  • DeviceSkeletal anchorage and intermaxillary elastic assisted maxillary protraction

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an avarage of 6 months

  2. 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.

    Time frame: Through study completion, an avarage of 6 months

  3. 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.

    Time frame: Through study completion, an avarage of 6 months

  4. 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.

    Time frame: Through study completion, an avarage of 6 months

07

Study locations

1 site
  • Erciyes University Faculty of Dentistry, Department of Orthodontics
    Kayseri, 38039, Turkey
08

References and documents

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. Erratum In: Am J Orthod Dentofacial Orthop. 2014 May;145(5):553-4. PubMed 24373654 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06763900
Responsible party
Ahmet Yağcı (Professor, TC Erciyes University) — Principal investigator
First posted
Jan 8, 2025
Start date
Mar 14, 2022
Primary completion
Mar 29, 2023
Completion
May 6, 2023
Last update
Jan 8, 2025

Study contacts

Ahmet YAĞCI, Professor
study director

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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