NCT04863404

Brief Summary

The aim of this prospective randomized controlled clinical study is to compare the effects of bone-anchored and tooth borne maxillary protraction on dentofacial structures in skeletal Class III patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 21, 2021

Last Update Submit

April 27, 2021

Conditions

Anterior CrossbiteClass III MalocclusionMaxillary Deficiency

Keywords

maxillary protractiontooth-borne vs bone-anchoredface maskAltRamecrmeTemporary anchorage devices (TADs) in the anterior palatehybrid hyrax

Outcome Measures

Primary Outcomes (2)

  • Pre-treatment (T0) cephalometric analysis measures

    A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions

    0 month

  • Pre-treatment (T0) soft tissues measurements

    Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry

    0 month

Secondary Outcomes (2)

  • Post-treatment (T1) cephalometric analysis measurements

    An average of 6 month

  • Post-treatment (T1) soft tissues measurements

    An average of 6 month

Study Arms (3)

Bone-anchored maxillary protraction group

EXPERIMENTAL

Face mask with hybrid-hyrax

Other: Face mask with hybrid-hyrax

Tooth-borne maxillary protraction group

EXPERIMENTAL

Face mask with conventional bonded RME

Other: Face mask with conventional bonded RME

Control group

NO INTERVENTION

Control group consisting of 14 non-treated Class III malocclusion subjects

Interventions

Face mask with hybrid-hyraxOTHER

Face mask with hybrid-hyrax

Bone-anchored maxillary protraction group
Face mask with conventional bonded RMEOTHER

Face mask with conventional bonded RME

Tooth-borne maxillary protraction group

Eligibility Criteria

Age10 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Late mixed or early permanent dentition
  • C3 or C4 period according to the cervical vertebral maturation method
  • Presence of skeletal class III malocclusion (ANB \<0 °).
  • Retrusive nasomaxillary complex (Nperp-A \<1 mm).
  • Presence of dental class III malocclusion
  • Normal or horizontal growth pattern (SNGoGn \<40 °).
  • Negative overjet (overjet \<0)
  • Good cooperation
  • Absence of any systemic disease
  • Periodontal health
  • No previous orthodontic treatment
  • No craniofacial deformity
  • No neuromuscular deformity
  • The absence of a congenital anomaly

You may not qualify if:

  • Poor cooperation
  • Early mixed dentition
  • Individuals who have passed the C4 period
  • Craniofacial deformity
  • Congenital anomaly
  • A history of facial trauma Syndromes such as cleft lip and palate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics

Izmir, Çiğli, 35640, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class IIIRetrognathiaTietz syndrome

Interventions

Masks

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic DiseasesJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Burcin AKAN, Phd

    Academician

    STUDY DIRECTOR

Central Study Contacts

Burcin AKAN, Phd

CONTACT

+90 5367103040Burcin.yksel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
3 arm parallel clinical trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 28, 2021

Study Start

June 15, 2020

Primary Completion

May 20, 2021

Study Completion

October 20, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

TU(1)