Corticotomy-Assisted Class III Elastic Applications

NCT06763900 | Completed

• 1 other identifier: TDH-2022-11536
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Class III Malocclusion

Keywords

Class III Malocclusion; Miniplates; Corticotomy; Skeletal Anchorage; Class III Elastics

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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).

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).

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).

Device: Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

Interventions

Skeletal anchorage and intermaxillary elastic assisted maxillary protraction DEVICE

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

Acrylic Splint Group (AS); Miniplate Group (MP); Palatal Miniscrew Supported Acrylic Splint Group (MS)

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Faculty of Dentistry, Department of Orthodontics

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 19761906 BACKGROUND

• 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.

  PMID: 24913740 BACKGROUND

• 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.

  PMID: 30345472 BACKGROUND

• 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.

  PMID: 18331946 BACKGROUND

• 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.

  PMID: 24373654 BACKGROUND

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ahmet YAĞCI, Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: January 8, 2025
• Study Start: March 14, 2022
• Primary Completion: March 29, 2023
• Study Completion: May 6, 2023
• Last Updated: January 8, 2025

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)