Corticotomy-Assisted Class III Elastic Applications (CACIIIEA)

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

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.

Study Overview

• Status: Completed
• Conditions: Class III Malocclusion
• Intervention / Treatment: Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; maxillary protraction with corticotomy-assisted different miniplate and intermaxillary elastic applications after growth spurt in patients with skeletal Class III malocclusion
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; maxillary protraction with corticotomy-assisted different miniplate and intermaxillary elastic applications after growth spurt in patients with skeletal Class III malocclusion
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; maxillary protraction with corticotomy-assisted different miniplate and intermaxillary elastic applications after growth spurt in patients with skeletal Class III malocclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Through study completion, an avarage of 6 months

Collaborators and Investigators

• Sponsor: TC Erciyes University
• Investigators: Study Director: Ahmet YAĞCI, Professor

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: June 7, 2023
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Class III Malocclusion; Corticotomy; Miniplates; Skeletal Anchorage; Class III Elastics
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Jaw Diseases; Tooth Diseases; Jaw Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: TDH-2022-11536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No