Clinical trial NCT06763900: Corticotomy-Assisted Class III Elastic Applications
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Keywords: Class III Malocclusion
Miniplates
Corticotomy
Skeletal Anchorage
Class III Elastics
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maxillomandibular sagittal changes
timeFrame: Through study completion, an avarage of 6 months
measure: Vertical changes
timeFrame: Through study completion, an avarage of 6 months
measure: Dentoalveolar changes
timeFrame: Through study completion, an avarage of 6 months
measure: Soft tissue changes
timeFrame: Through study completion, an avarage of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University Faculty of Dentistry, Department of Orthodontics
Study officials:
name: Ahmet YAĞCI, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.