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Completed

NCT Number: NCT06763900

Corticotomy-Assisted Class III Elastic Applications

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.

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Key information

Conditions

Class III Malocclusion Malocclusion Malocclusion, Angle Class III Stomatognathic Diseases Tooth Diseases

Age range

13 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University Faculty of Dentistry, Department of Orthodontics

Kayseri, 38039, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Maxillomandibular sagittal changes

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

    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.

  2. Vertical changes

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

    Investigation of Angular changes in Y-axis angle (°), SN-GoGN (°), SN-PP (°), Jarabak ratio measurements.

    Investigation of Distance changes in A-HRL (mm) measurement.

  3. Dentoalveolar changes

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

    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.

  4. Soft tissue changes

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

    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.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

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

Acronym: CACIIIEA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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