Corticotomy-Assisted Class III Elastic Applications

NCT ID: NCT06763900

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2023-05-06

Brief Summary

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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.

Detailed Description

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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

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Class III Malocclusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

Intervention Type 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)

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).

Group Type EXPERIMENTAL

Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

Intervention Type DEVICE

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

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).

Group Type EXPERIMENTAL

Skeletal anchorage and intermaxillary elastic assisted maxillary protraction

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Yağcı

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmet YAĞCI, Professor

Role: STUDY_DIRECTOR

Locations

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Erciyes University Faculty of Dentistry, Department of Orthodontics

Kayseri, Kayseri, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 19761906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24913740 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30345472 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18331946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24373654 (View on PubMed)

Other Identifiers

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TDH-2022-11536

Identifier Type: -

Identifier Source: org_study_id

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